Vice President, Quality Assurance - GMP
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Also remove the accommodation email line? That's part of application instructions? It's a contact for accommodation; likely considered application instructions, remove. Also remove disclaimer, EEO statement. Also remove Working Conditions? It's not a required heading but could be included as a section if content present. The allowed headings list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can also add other headings if needed? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are examples; we could also use other headings if appropriate, but better to stick to those. We have content: Summary/Job Purpose could be "About the role". Essential Duties/Responsibilities -> "Responsibilities". Supervisory Responsibilities maybe also part of Responsibilities; could combine. Education/Experience/Knowledge/Skills & Abilities -> could be "Qualifications" or "Requirements" and "Skills". We need to decide.
We have compensation (Pay) and benefits (Benefits). No schedule info. So we will include About the role, Responsibilities, Qualifications, Skills, Benefits, Pay.
We must not invent or summarize away detail. Preserve ALL substantive information. So we need to include all duties, responsibilities, supervisory responsibilities, education/experience, knowledge/skills/abilities, compensation, benefits. Also maybe Working Conditions? Not in allowed headings but could be omitted. The instruction: "Prefer a few substantive sections over many thin ones." So we can combine.
We need to use - for any list of duties/requirements/benefits. For prose, use
. So we need to decide which parts are lists.
Essential Duties/Responsibilities is a long list of bullet-like sentences but not formatted as bullets. We can turn each sentence into a
- . Similarly Supervisory Responsibilities can be list items. Education/Experience/Knowledge/Skills & Abilities: we have Education (multiple options), Experience (bullet points), Required Knowledge, Skills and Abilities (bullet points). We'll make lists.
Benefits: list of benefits: 401k plan, medical/dental/vision, life/disability insurance, flexible spending accounts, discretionary annual bonus, opportunity to purchase company stock, long-term incentives, 15 accrued vacation days first year, 17 paid holidays including company-wide winter shutdown, up to 10 sick days. We'll list.
Pay: we have base pay range $315,500 - $366,500 annually, plus note about geographic region adjustments. We'll put in
.
We must not include boilerplate like "Complies with all policies and standards" maybe part of responsibilities? It's a line at end of Essential Duties/Responsibilities: "Performs other duties as assignedComplies with all policies and standards". Actually it's "Performs other duties as assignedComplies with all policies and standards". That's part of responsibilities; we can keep as a duty.
We need to remove the accommodation email line and disclaimer, EEO statement.
Also remove "Working Conditions" paragraph? It's not boilerplate but it's not in allowed headings; we could omit it as it's not required. However it's substantive info about office environment. Could we include as a section "Working Conditions"? Not in examples but maybe allowed. The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are typical but not exclusive. Safer to stick to those. So we omit Working Conditions.
Now produce HTML fragment.
Structure:
About the role
Summary/Job Purpose text.
Responsibilities
- Lead and oversee the GMP Quality Assurance department
- Drive compliant execution across all GMP QA responsibilities in alignment with the enterprise GMP Quality Assurance strategy
- Lead organizational readiness for GMP inspections at Exelixis and third-party vendors, including regulatory inspections by the FDA and other agencies and audits or inspections by collaboration partners
- Lead Quality input into GMP quality agreements to ensure they support operational needs, compliance expectations and appropriate Quality oversight
- Oversee final review and disposition of clinical and commercial materials and products in compliance with global regulatory standards to ensure reliability, quality, efficacy and compliance
- Lead GMP Operations QA, Labeling QA, Audit and Inspection Readiness and associated Quality functions to ensure QA GMP operates at the highest standards
- Partner with the Head of Quality Systems to ensure GMP QA requirements are reflected in Quality systems, governance processes, and continuous improvement activities
- Oversee labeling governance for clinical and commercial products to support regulatory compliance and consistency
- Partner with PSC functions to establish effective GMP supplier quality and vendor audit programs
- Ensure independent Quality oversight of manufacturing, testing, distribution and external partners
- Ensure effective execution of investigations, root cause analysis, risk assessments, change controls and CAPAs at Exelixis and third-party contractors
- Ensure performance metrics for GMP QA are established, appropriate and regularly assessed
- Identify, evaluate and escalate product quality risks to senior leadership
- Represent GMP Quality in cross-functional governance forums and regulatory interactions
- Lead and develop organizational capability, including talent strategy and succession planning
- Performs other duties as assigned
- Complies with all policies and standards
Maybe also include supervisory responsibilities as part of responsibilities; we could add them as additional list items.
Add supervisory responsibilities items:
continue? Could add another Supervisory Responsibilities
but not in allowed headings. Better to merge into Responsibilities.
Add items:
- Provide executive leadership for GMP Quality Assurance, including GMP Operations QA, audit, inspection readiness and associated Quality functions
- Develop organizational structure, recruit talent and manage performance of direct and indirect reports
- Set organizational priorities and align resources to meet business objectives
- Partner across functions to achieve organizational goals and ensure compliance
- Serve on the enterprise Quality leadership team, providing independent oversight, cross-functional governance, and escalation of Quality-related risks and decisions in partnership with GCP/GVP QA and Quality Systems and Process functions
Now Education/Experience/Knowledge/Skills & Abilities.
We could have Qualifications
with sub-sections? But we need to use - for any list. Could break into Education, Experience, Required Knowledge, Skills and Abilities as separate lists under Qualifications? Might be okay to have multiple
under same heading.
We'll do:
Qualifications
Education
but h4 not allowed? Only h3 for section headings. Could just use for Education prose? But we have multiple options; better to use
.
We can do:
Qualifications
Education: BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or, MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or, PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or, Equivalent combination of education and experience. Advanced degree preferred.
Then Experience list:
Experience
maybe not allowed but could be considered a section. The instruction says use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Experience could be part of Qualifications. But we need to preserve all substantive info; we can include Experience as a list under Qualifications.
Simplify: Under Qualifications, we have subheadings? Not allowed. Could just make a single list combining all bullet points: Education options, Experience bullet points, Required Knowledge, Skills and Abilities bullet points. That would be a long list but okay.
But we need to differentiate? Not required. The instruction: "Use - for any list of duties/requirements/benefits". So we can make a list for requirements/qualifications.
Thus:
Qualifications
- BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or equivalent combination of education and experience. Advanced degree preferred.
- Extensive experience in biotechnology, pharmaceutical or regulated industry
- Significant leadership experience in GMP Quality Assurance
- Experience with regulatory inspections and global GMP audit programs
- Experience overseeing external manufacturing and supply networks
- Experience leading Quality organizations through commercialization, expansion or organizational change (preferred)
- Comprehensive knowledge of global GMP regulations and Quality systems
- Advanced leadership, analytical and problem-solving skills
- Strong executive communication skills with the ability to translate technical concepts for diverse audiences
- Ability to work with ambiguity and make risk-based decisions
- Ability to align Quality strategies across functions and GxP domains
- Demonstrated ability to lead organizational transformation and change
- Experience interacting with global regulatory agencies and executive governance bodies
- Ability to influence enterprise strategy and organizational decision-making
Now Benefits:
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program (or sales-based incentive plan for field sales staff)
- Opportunity to purchase company stock and receive long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
Pay:
Pay
The base pay range for this position is $315,500 - $366,
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Also remove the accommodation email line? That's part of application instructions? It's a contact for accommodation; likely considered application instructions, remove. Also remove disclaimer, EEO statement. Also remove Working Conditions? It's not a required heading but could be included as a section if content present. The allowed headings list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can also add other headings if needed? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are examples; we could also use other headings if appropriate, but better to stick to those. We have content: Summary/Job Purpose could be "About the role". Essential Duties/Responsibilities -> "Responsibilities". Supervisory Responsibilities maybe also part of Responsibilities; could combine. Education/Experience/Knowledge/Skills & Abilities -> could be "Qualifications" or "Requirements" and "Skills". We need to decide.
We have compensation (Pay) and benefits (Benefits). No schedule info. So we will include About the role, Responsibilities, Qualifications, Skills, Benefits, Pay.
We must not invent or summarize away detail. Preserve ALL substantive information. So we need to include all duties, responsibilities, supervisory responsibilities, education/experience, knowledge/skills/abilities, compensation, benefits. Also maybe Working Conditions? Not in allowed headings but could be omitted. The instruction: "Prefer a few substantive sections over many thin ones." So we can combine.
We need to use - for any list of duties/requirements/benefits. For prose, use
. So we need to decide which parts are lists.
Essential Duties/Responsibilities is a long list of bullet-like sentences but not formatted as bullets. We can turn each sentence into a
- . Similarly Supervisory Responsibilities can be list items. Education/Experience/Knowledge/Skills & Abilities: we have Education (multiple options), Experience (bullet points), Required Knowledge, Skills and Abilities (bullet points). We'll make lists.
Benefits: list of benefits: 401k plan, medical/dental/vision, life/disability insurance, flexible spending accounts, discretionary annual bonus, opportunity to purchase company stock, long-term incentives, 15 accrued vacation days first year, 17 paid holidays including company-wide winter shutdown, up to 10 sick days. We'll list.
Pay: we have base pay range $315,500 - $366,500 annually, plus note about geographic region adjustments. We'll put in
.
We must not include boilerplate like "Complies with all policies and standards" maybe part of responsibilities? It's a line at end of Essential Duties/Responsibilities: "Performs other duties as assignedComplies with all policies and standards". Actually it's "Performs other duties as assignedComplies with all policies and standards". That's part of responsibilities; we can keep as a duty.
We need to remove the accommodation email line and disclaimer, EEO statement.
Also remove "Working Conditions" paragraph? It's not boilerplate but it's not in allowed headings; we could omit it as it's not required. However it's substantive info about office environment. Could we include as a section "Working Conditions"? Not in examples but maybe allowed. The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are typical but not exclusive. Safer to stick to those. So we omit Working Conditions.
Now produce HTML fragment.
Structure:
About the role
Summary/Job Purpose text.
Responsibilities
- Lead and oversee the GMP Quality Assurance department
- Drive compliant execution across all GMP QA responsibilities in alignment with the enterprise GMP Quality Assurance strategy
- Lead organizational readiness for GMP inspections at Exelixis and third-party vendors, including regulatory inspections by the FDA and other agencies and audits or inspections by collaboration partners
- Lead Quality input into GMP quality agreements to ensure they support operational needs, compliance expectations and appropriate Quality oversight
- Oversee final review and disposition of clinical and commercial materials and products in compliance with global regulatory standards to ensure reliability, quality, efficacy and compliance
- Lead GMP Operations QA, Labeling QA, Audit and Inspection Readiness and associated Quality functions to ensure QA GMP operates at the highest standards
- Partner with the Head of Quality Systems to ensure GMP QA requirements are reflected in Quality systems, governance processes, and continuous improvement activities
- Oversee labeling governance for clinical and commercial products to support regulatory compliance and consistency
- Partner with PSC functions to establish effective GMP supplier quality and vendor audit programs
- Ensure independent Quality oversight of manufacturing, testing, distribution and external partners
- Ensure effective execution of investigations, root cause analysis, risk assessments, change controls and CAPAs at Exelixis and third-party contractors
- Ensure performance metrics for GMP QA are established, appropriate and regularly assessed
- Identify, evaluate and escalate product quality risks to senior leadership
- Represent GMP Quality in cross-functional governance forums and regulatory interactions
- Lead and develop organizational capability, including talent strategy and succession planning
- Performs other duties as assigned
- Complies with all policies and standards
Maybe also include supervisory responsibilities as part of responsibilities; we could add them as additional list items.
Add supervisory responsibilities items:
continue? Could add another Supervisory Responsibilities
but not in allowed headings. Better to merge into Responsibilities.
Add items:
- Provide executive leadership for GMP Quality Assurance, including GMP Operations QA, audit, inspection readiness and associated Quality functions
- Develop organizational structure, recruit talent and manage performance of direct and indirect reports
- Set organizational priorities and align resources to meet business objectives
- Partner across functions to achieve organizational goals and ensure compliance
- Serve on the enterprise Quality leadership team, providing independent oversight, cross-functional governance, and escalation of Quality-related risks and decisions in partnership with GCP/GVP QA and Quality Systems and Process functions
Now Education/Experience/Knowledge/Skills & Abilities.
We could have Qualifications
with sub-sections? But we need to use - for any list. Could break into Education, Experience, Required Knowledge, Skills and Abilities as separate lists under Qualifications? Might be okay to have multiple
under same heading.
We'll do:
Qualifications
Education
but h4 not allowed? Only h3 for section headings. Could just use for Education prose? But we have multiple options; better to use
.
We can do:
Qualifications
Education: BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or, MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or, PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or, Equivalent combination of education and experience. Advanced degree preferred.
Then Experience list:
Experience
maybe not allowed but could be considered a section. The instruction says use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Experience could be part of Qualifications. But we need to preserve all substantive info; we can include Experience as a list under Qualifications.
Simplify: Under Qualifications, we have subheadings? Not allowed. Could just make a single list combining all bullet points: Education options, Experience bullet points, Required Knowledge, Skills and Abilities bullet points. That would be a long list but okay.
But we need to differentiate? Not required. The instruction: "Use - for any list of duties/requirements/benefits". So we can make a list for requirements/qualifications.
Thus:
Qualifications
- BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or equivalent combination of education and experience. Advanced degree preferred.
- Extensive experience in biotechnology, pharmaceutical or regulated industry
- Significant leadership experience in GMP Quality Assurance
- Experience with regulatory inspections and global GMP audit programs
- Experience overseeing external manufacturing and supply networks
- Experience leading Quality organizations through commercialization, expansion or organizational change (preferred)
- Comprehensive knowledge of global GMP regulations and Quality systems
- Advanced leadership, analytical and problem-solving skills
- Strong executive communication skills with the ability to translate technical concepts for diverse audiences
- Ability to work with ambiguity and make risk-based decisions
- Ability to align Quality strategies across functions and GxP domains
- Demonstrated ability to lead organizational transformation and change
- Experience interacting with global regulatory agencies and executive governance bodies
- Ability to influence enterprise strategy and organizational decision-making
Now Benefits:
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program (or sales-based incentive plan for field sales staff)
- Opportunity to purchase company stock and receive long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
Pay:
Pay
The base pay range for this position is $315,500 - $366,
. So we need to decide which parts are lists. Essential Duties/Responsibilities is a long list of bullet-like sentences but not formatted as bullets. We can turn each sentence into a
. We must not include boilerplate like "Complies with all policies and standards" maybe part of responsibilities? It's a line at end of Essential Duties/Responsibilities: "Performs other duties as assignedComplies with all policies and standards". Actually it's "Performs other duties as assignedComplies with all policies and standards". That's part of responsibilities; we can keep as a duty. We need to remove the accommodation email line and disclaimer, EEO statement. Also remove "Working Conditions" paragraph? It's not boilerplate but it's not in allowed headings; we could omit it as it's not required. However it's substantive info about office environment. Could we include as a section "Working Conditions"? Not in examples but maybe allowed. The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are typical but not exclusive. Safer to stick to those. So we omit Working Conditions.
Now produce HTML fragment.
Structure:
About the role
About the role
Summary/Job Purpose text.
Responsibilities
- Lead and oversee the GMP Quality Assurance department
- Drive compliant execution across all GMP QA responsibilities in alignment with the enterprise GMP Quality Assurance strategy
- Lead organizational readiness for GMP inspections at Exelixis and third-party vendors, including regulatory inspections by the FDA and other agencies and audits or inspections by collaboration partners
- Lead Quality input into GMP quality agreements to ensure they support operational needs, compliance expectations and appropriate Quality oversight
- Oversee final review and disposition of clinical and commercial materials and products in compliance with global regulatory standards to ensure reliability, quality, efficacy and compliance
- Lead GMP Operations QA, Labeling QA, Audit and Inspection Readiness and associated Quality functions to ensure QA GMP operates at the highest standards
- Partner with the Head of Quality Systems to ensure GMP QA requirements are reflected in Quality systems, governance processes, and continuous improvement activities
- Oversee labeling governance for clinical and commercial products to support regulatory compliance and consistency
- Partner with PSC functions to establish effective GMP supplier quality and vendor audit programs
- Ensure independent Quality oversight of manufacturing, testing, distribution and external partners
- Ensure effective execution of investigations, root cause analysis, risk assessments, change controls and CAPAs at Exelixis and third-party contractors
- Ensure performance metrics for GMP QA are established, appropriate and regularly assessed
- Identify, evaluate and escalate product quality risks to senior leadership
- Represent GMP Quality in cross-functional governance forums and regulatory interactions
- Lead and develop organizational capability, including talent strategy and succession planning
- Performs other duties as assigned
- Complies with all policies and standards
- continue? Could add another
- Provide executive leadership for GMP Quality Assurance, including GMP Operations QA, audit, inspection readiness and associated Quality functions
- Develop organizational structure, recruit talent and manage performance of direct and indirect reports
- Set organizational priorities and align resources to meet business objectives
- Partner across functions to achieve organizational goals and ensure compliance
- Serve on the enterprise Quality leadership team, providing independent oversight, cross-functional governance, and escalation of Quality-related risks and decisions in partnership with GCP/GVP QA and Quality Systems and Process functions Now Education/Experience/Knowledge/Skills & Abilities. We could have
- for any list. Could break into Education, Experience, Required Knowledge, Skills and Abilities as separate lists under Qualifications? Might be okay to have multiple
- under same heading.
We'll do:
- for any list of duties/requirements/benefits". So we can make a list for requirements/qualifications.
Thus:
Qualifications
- BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or equivalent combination of education and experience. Advanced degree preferred.
- Extensive experience in biotechnology, pharmaceutical or regulated industry
- Significant leadership experience in GMP Quality Assurance
- Experience with regulatory inspections and global GMP audit programs
- Experience overseeing external manufacturing and supply networks
- Experience leading Quality organizations through commercialization, expansion or organizational change (preferred)
- Comprehensive knowledge of global GMP regulations and Quality systems
- Advanced leadership, analytical and problem-solving skills
- Strong executive communication skills with the ability to translate technical concepts for diverse audiences
- Ability to work with ambiguity and make risk-based decisions
- Ability to align Quality strategies across functions and GxP domains
- Demonstrated ability to lead organizational transformation and change
- Experience interacting with global regulatory agencies and executive governance bodies
- Ability to influence enterprise strategy and organizational decision-making
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program (or sales-based incentive plan for field sales staff)
- Opportunity to purchase company stock and receive long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
Pay
The base pay range for this position is $315,500 - $366,
Qualifications
Education
but h4 not allowed? Only h3 for section headings. Could just usefor Education prose? But we have multiple options; better to use
- .
We can do:
Qualifications
Education: BS/BA degree in life sciences, engineering or related discipline and a minimum of 21 years of relevant experience; or, MS/MA degree in life sciences, engineering or related discipline and a minimum of 19 years of relevant experience; or, PhD in life sciences, engineering or related discipline and a minimum of 17 years of relevant experience; or, Equivalent combination of education and experience. Advanced degree preferred.
Then Experience list:Experience
maybe not allowed but could be considered a section. The instruction says use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Experience could be part of Qualifications. But we need to preserve all substantive info; we can include Experience as a list under Qualifications. Simplify: Under Qualifications, we have subheadings? Not allowed. Could just make a single list combining all bullet points: Education options, Experience bullet points, Required Knowledge, Skills and Abilities bullet points. That would be a long list but okay. But we need to differentiate? Not required. The instruction: "Use - for any list of duties/requirements/benefits". So we can make a list for requirements/qualifications.
Thus: