Executive Director, Quality
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content.
We have content: description (overview) maybe "About the role". Then "Essential Duties and Responsibilities" -> Responsibilities. Then "Qualifications" -> Qualifications. Also there are some skills mentioned: knowledge of regulations, etc. Could be Skills section. There's no explicit Benefits, Pay, Schedule. So we omit those.
We must not repeat job title as heading. No Job ID. Remove boilerplate EEO etc. Also remove "Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future" maybe that's fluff but it's substantive? It's more of a tagline; could be considered part of About the role? Might keep as prose.
We need to preserve all substantive information, not invent or summarize away detail. Must not include filler like "commensurate with experience". Not present.
We need to use - for any list of duties/requirements/benefits. The duties are in paragraphs; we could convert each sentence into list items? The instruction: Use
- for any list of duties/requirements/benefits. The posting has a block of duties described in paragraphs, not explicitly a list. But we could still treat them as list items? Might be safer to keep as
for prose, but if we have a list we need to use
. The duties are not bullet list; they are sentences. So we can keep as . However the instruction says "Use
- for any list of duties/requirements/benefits". If not a list, we don't need to use.
Qualifications: also paragraph.
We could extract bullet-like items: but better to keep as prose.
We need to include sections only when posting has real specific content. So we will have:
About the role
... overview ...
Responsibilities
... duties ...
Qualifications
... qualifications ...
Possibly also a Skills section: we could pull out skills like "Strong knowledge base in production, aseptic operations, microbiology, analytical chemistry, and validation", "Experience in facilitating Regulatory Agency inspections", etc. But those are within qualifications. Might be redundant.
We should not create sections with filler. So we stick to three sections.
Now we need to preserve all substantive information. Let's extract the overview text:
"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Executive Director, Quality provides strategic and operational leadership for Quality across the Development & Manufacturing Bedford campus, overseeing QA, QC, Validation, and the Quality Management System. This role is accountable for regulatory compliance, inspection readiness, patient safety, and Right-First-Time manufacturing while positioning Quality as a competitive advantage for PCI. As a key member of the Site Leadership Team and strategic partner to the Site GM, the Executive Director balances quality, safety, production, financial, supply, and customer priorities while building a high-performing Quality organization. The role also drives long-term Quality strategy, talent development, continuous improvement, regulatory readiness, and resource planning."
That's the overview.
Now Responsibilities: The block after "Essential Duties and Responsibilities:" includes many sentences. Let's capture them:
"Develop, implement and communicate a clear strategic vision for Quality to be a Competitive Advantage throughout PCI.
Ensure QMS and other systems are functioning to maximize employee focus and enable Right-First-Time manufacturing.
Takes accountability for a constant state of inspection readiness, prioritizing regulatory compliance as a foundational requirement for stable patient supply.
Ability to anticipate changes in the regulatory climate, and redesign processes accordingly.
As a senior leader on site and direct quality partner to the Site GM, understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met.
The SQH will develop a Quality Team capable of finding solutions that meet all must-have needs of all partners without ever compromising the safety of patients or the reputation of PCI.
Lead a team with overall responsibilities for QA, QC, & Validation across the D&M campus. This requires leadership in the day, to meet current needs. It also requires leadership for tomorrow to ensure development of personnel, succession planning, investment planning in systems and equipment, and continual pressure across the Site Leadership Team (SLT) to always have robustness and reliability at the forefront of all decisions.
The SQH is highly visible as a core member of the SLT.
The SQH is aware that their behavior influences the behavior of everyone within Quality and on the site.
The SQH models senior leadership behaviors.
Responsible for the quality aspects associated with manufacturing, testing, packaging, storage and release of clinical, commercial drug products and medical devices (as applicable) produced at the Development and Manufacturing facilities.
Responsible for compliance to global standards of cGMP, as applicable.
Maintaining alignment with the SLT, the SQH translates Corporate and Segment requirements into Site Quality Strategic Planning and Quality yearly objectives, setting that meet compliance requirements and business needs.
Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards.
Oversees compliance operations, responsible for complaint evaluation, internal and external investigations, internal and external supplier auditing, batch audit and disposition, and product data trending, etc.
Manages and coordinates all the regulatory inspections for Development and Manufacturing facilities.
Acts as primary interface for communication with Regulatory Agency field inspectors.
Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our clients, partners and suppliers.
Annually, develops Quality budget and then maintains budget throughout the fiscal year."
We need to keep all that. Could be a single paragraph but it's long; maybe break into but it's okay.
Now Qualifications: The block after "Qualifications:" includes many sentences. Let's capture:
"Approximately 15+ years’ experience in a similar organization with at least five of those years in a senior management role, with the majority of this experience gained in an aseptic or sterile production environment.
Contract Manufacturing experience is a plus
Experience in Operations or Supply Chain, as well as core experience in Quality is a plus
Requires a solid knowledge of global regulatory guidance in including, but not limited to, CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1).
Ability to interpret other global regulations as necessary is required (e.g., WHO, ANVISA, etc).
Must have a demonstrable record of implementing and maintaining and total quality system, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.
This person will assure that systems are in place and that inter- and intradepartmental communications are such that “things be done only once – the right way.”
Successful development and implementation of a quality strategy for a manufacturing operations environment.
Successful in implementing consistent standards.
Strong knowledge base in production, aseptic operations, microbiology, analytical chemistry, and validation is required.
It is acknowledged that background across these fields may be developed in many different forms.
Experience in facilitating Regulatory Agency inspections and communicating with global Regulatory Agencies.
Requires a minimum of a bachelor’s degree, with preference for those in life sciences, chemistry, engineering or other science disciplines.
An advanced degree is desirable.
Hands-on experience with QMS data management software (eQMS), process mapping tools, risk assessments, data analysis, and software for presentation of all of these is required.
The ability to communicate the compliance status as well as measure it is paramount to success in this role.
Cross-functional leadership and influence is necessary for success, with this role leading process risk assessments, program improvements, and other activities that require input from multiple stakeholders with multiple priorities, all of which must be met sufficiently."
We need to preserve all that.
Now we need to output HTML fragment only, no or . Use
for headings. Use
for prose. No lists unless we have list; we have paragraphs.
We should ensure we don't include boilerplate like EEO statement etc. Also remove "Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future" maybe it's fluff but it's part of the posting after Qualifications? Actually it's after Qualifications before EEO. It's a tagline; could be considered part of About the role? Might be considered substantive? It's a call to action; but it's not essential info about role. Might be considered boilerplate? It's not navigation/legal/EEO. It's a motivational line. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This line is not those. It's more of a tagline; could be kept. But it's not really about the role; it's a generic closing. Might be considered filler but not explicitly prohibited. Safer to keep it as part of About the role? It appears after Qualifications before EEO. Could be considered a separate paragraph but we could include it in About the role? Might be odd.
Better to include it as a separate paragraph after Qualifications? But we have no section for that. Could add a
after Qualifications before closing. However instruction: Prefer a few substantive sections over many thin ones. Adding a separate paragraph without heading might be okay as part of the flow? But we need to output only HTML fragment; we could just include it as a
after Qualifications without heading. But that would be stray content not under a heading. The instruction didn't forbid stray paragraphs; just said use
for section headings, - for lists,
for prose. So we can have multiple
elements.
Thus we can output:
About the role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Executive Director, Quality provides strategic and operational leadership for Quality across the Development & Manufacturing Bedford campus, overseeing QA, QC, Validation, and the Quality Management System. This role is accountable for regulatory compliance, inspection readiness, patient safety, and Right-First-Time manufacturing while positioning Quality as a competitive advantage for PCI. As a key member of the Site Leadership Team and strategic partner to the Site GM, the Executive Director balances quality, safety, production, financial, supply, and customer priorities while building a high-performing Quality organization. The role also drives long-term Quality strategy, talent development, continuous improvement, regulatory readiness, and resource planning.
Responsibilities
Develop, implement and communicate a clear strategic vision for Quality to be a Competitive Advantage throughout PCI. Ensure QMS and other systems are functioning to maximize employee focus and enable Right-First-Time manufacturing. Takes accountability for a constant state of inspection readiness, prioritizing regulatory compliance as a foundational requirement for stable patient supply. Ability to anticipate changes in the regulatory climate, and redesign processes accordingly. As a senior leader on site and direct quality partner to the Site GM, understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met. The SQH will develop a Quality Team capable of finding solutions that meet all must-have needs of all partners without ever compromising the safety of patients or the reputation of PCI. Lead a team with overall responsibilities for QA, QC, & Validation across the
- for any list of duties/requirements/benefits. The posting has a block of duties described in paragraphs, not explicitly a list. But we could still treat them as list items? Might be safer to keep as
for prose, but if we have a list we need to use
- . The duties are not bullet list; they are sentences. So we can keep as
- for any list of duties/requirements/benefits". If not a list, we don't need to use.
Qualifications: also paragraph.
We could extract bullet-like items: but better to keep as prose.
We need to include sections only when posting has real specific content. So we will have:
About the role
... overview ...
Responsibilities
... duties ...
Qualifications
... qualifications ...
Possibly also a Skills section: we could pull out skills like "Strong knowledge base in production, aseptic operations, microbiology, analytical chemistry, and validation", "Experience in facilitating Regulatory Agency inspections", etc. But those are within qualifications. Might be redundant. We should not create sections with filler. So we stick to three sections. Now we need to preserve all substantive information. Let's extract the overview text: "Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Executive Director, Quality provides strategic and operational leadership for Quality across the Development & Manufacturing Bedford campus, overseeing QA, QC, Validation, and the Quality Management System. This role is accountable for regulatory compliance, inspection readiness, patient safety, and Right-First-Time manufacturing while positioning Quality as a competitive advantage for PCI. As a key member of the Site Leadership Team and strategic partner to the Site GM, the Executive Director balances quality, safety, production, financial, supply, and customer priorities while building a high-performing Quality organization. The role also drives long-term Quality strategy, talent development, continuous improvement, regulatory readiness, and resource planning." That's the overview. Now Responsibilities: The block after "Essential Duties and Responsibilities:" includes many sentences. Let's capture them: "Develop, implement and communicate a clear strategic vision for Quality to be a Competitive Advantage throughout PCI. Ensure QMS and other systems are functioning to maximize employee focus and enable Right-First-Time manufacturing. Takes accountability for a constant state of inspection readiness, prioritizing regulatory compliance as a foundational requirement for stable patient supply. Ability to anticipate changes in the regulatory climate, and redesign processes accordingly. As a senior leader on site and direct quality partner to the Site GM, understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met. The SQH will develop a Quality Team capable of finding solutions that meet all must-have needs of all partners without ever compromising the safety of patients or the reputation of PCI. Lead a team with overall responsibilities for QA, QC, & Validation across the D&M campus. This requires leadership in the day, to meet current needs. It also requires leadership for tomorrow to ensure development of personnel, succession planning, investment planning in systems and equipment, and continual pressure across the Site Leadership Team (SLT) to always have robustness and reliability at the forefront of all decisions. The SQH is highly visible as a core member of the SLT. The SQH is aware that their behavior influences the behavior of everyone within Quality and on the site. The SQH models senior leadership behaviors. Responsible for the quality aspects associated with manufacturing, testing, packaging, storage and release of clinical, commercial drug products and medical devices (as applicable) produced at the Development and Manufacturing facilities. Responsible for compliance to global standards of cGMP, as applicable. Maintaining alignment with the SLT, the SQH translates Corporate and Segment requirements into Site Quality Strategic Planning and Quality yearly objectives, setting that meet compliance requirements and business needs. Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards. Oversees compliance operations, responsible for complaint evaluation, internal and external investigations, internal and external supplier auditing, batch audit and disposition, and product data trending, etc. Manages and coordinates all the regulatory inspections for Development and Manufacturing facilities. Acts as primary interface for communication with Regulatory Agency field inspectors. Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our clients, partners and suppliers. Annually, develops Quality budget and then maintains budget throughout the fiscal year." We need to keep all that. Could be a single paragraph but it's long; maybe break intobut it's okay. Now Qualifications: The block after "Qualifications:" includes many sentences. Let's capture: "Approximately 15+ years’ experience in a similar organization with at least five of those years in a senior management role, with the majority of this experience gained in an aseptic or sterile production environment. Contract Manufacturing experience is a plus Experience in Operations or Supply Chain, as well as core experience in Quality is a plus Requires a solid knowledge of global regulatory guidance in including, but not limited to, CFR 210 and 211, 820, cGXP, ICH Q8, Q9 and Q10, and EU/Eudralex (including Annex 1). Ability to interpret other global regulations as necessary is required (e.g., WHO, ANVISA, etc). Must have a demonstrable record of implementing and maintaining and total quality system, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. This person will assure that systems are in place and that inter- and intradepartmental communications are such that “things be done only once – the right way.” Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards. Strong knowledge base in production, aseptic operations, microbiology, analytical chemistry, and validation is required. It is acknowledged that background across these fields may be developed in many different forms. Experience in facilitating Regulatory Agency inspections and communicating with global Regulatory Agencies. Requires a minimum of a bachelor’s degree, with preference for those in life sciences, chemistry, engineering or other science disciplines. An advanced degree is desirable. Hands-on experience with QMS data management software (eQMS), process mapping tools, risk assessments, data analysis, and software for presentation of all of these is required. The ability to communicate the compliance status as well as measure it is paramount to success in this role. Cross-functional leadership and influence is necessary for success, with this role leading process risk assessments, program improvements, and other activities that require input from multiple stakeholders with multiple priorities, all of which must be met sufficiently." We need to preserve all that. Now we need to output HTML fragment only, no or . Use
for headings. Use
for prose. No lists unless we have list; we have paragraphs. We should ensure we don't include boilerplate like EEO statement etc. Also remove "Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future" maybe it's fluff but it's part of the posting after Qualifications? Actually it's after Qualifications before EEO. It's a tagline; could be considered part of About the role? Might be considered substantive? It's a call to action; but it's not essential info about role. Might be considered boilerplate? It's not navigation/legal/EEO. It's a motivational line. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This line is not those. It's more of a tagline; could be kept. But it's not really about the role; it's a generic closing. Might be considered filler but not explicitly prohibited. Safer to keep it as part of About the role? It appears after Qualifications before EEO. Could be considered a separate paragraph but we could include it in About the role? Might be odd. Better to include it as a separate paragraph after Qualifications? But we have no section for that. Could add a
after Qualifications before closing. However instruction: Prefer a few substantive sections over many thin ones. Adding a separate paragraph without heading might be okay as part of the flow? But we need to output only HTML fragment; we could just include it as a
after Qualifications without heading. But that would be stray content not under a heading. The instruction didn't forbid stray paragraphs; just said use
for section headings,
- for lists,
for prose. So we can have multiple
elements. Thus we can output:
About the role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Executive Director, Quality provides strategic and operational leadership for Quality across the Development & Manufacturing Bedford campus, overseeing QA, QC, Validation, and the Quality Management System. This role is accountable for regulatory compliance, inspection readiness, patient safety, and Right-First-Time manufacturing while positioning Quality as a competitive advantage for PCI. As a key member of the Site Leadership Team and strategic partner to the Site GM, the Executive Director balances quality, safety, production, financial, supply, and customer priorities while building a high-performing Quality organization. The role also drives long-term Quality strategy, talent development, continuous improvement, regulatory readiness, and resource planning.
Responsibilities
Develop, implement and communicate a clear strategic vision for Quality to be a Competitive Advantage throughout PCI. Ensure QMS and other systems are functioning to maximize employee focus and enable Right-First-Time manufacturing. Takes accountability for a constant state of inspection readiness, prioritizing regulatory compliance as a foundational requirement for stable patient supply. Ability to anticipate changes in the regulatory climate, and redesign processes accordingly. As a senior leader on site and direct quality partner to the Site GM, understands that the needs of worker safety, quality, environmental compliance, finance and production, supply and our customers must all be met. The SQH will develop a Quality Team capable of finding solutions that meet all must-have needs of all partners without ever compromising the safety of patients or the reputation of PCI. Lead a team with overall responsibilities for QA, QC, & Validation across the
- for lists,
. However the instruction says "Use
- for any list of duties/requirements/benefits". If not a list, we don't need to use.
Qualifications: also paragraph.
We could extract bullet-like items: but better to keep as prose.
We need to include sections only when posting has real specific content. So we will have: