Senior Director, GMP Quality
for each section heading. Use - for lists. Use
for prose.
We must not include sections with filler like "commensurate with experience". Not present.
We need to decide what goes where.
Section "About the role": could be the introductory paragraph: "The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality."
That's substantive.
Section "Responsibilities": the list after "Here's how you will contribute:" includes many bullet-like sentences. We'll turn each sentence into
- .
Section "Requirements": maybe the "Leadership Qualities:"? Or "The Ideal Candidate will have:" includes mandatory qualifications. Could treat "The Ideal Candidate will have:" as Requirements (mandatory). Then "Nice to Have" as Qualifications? Or Skills? The headings list includes Requirements, Qualifications, Skills. We need to map.
We could do:
- Requirements: The Ideal Candidate will have: list (Bachelors degree, 15+ years, etc.) (these are mandatory)
- Qualifications: Leadership Qualities (maybe describing desired leadership traits)
- Skills: Nice to Have (additional desirable experience)
But we need to ensure we don't invent content. Use actual text.
Let's extract each.
From posting:
**Leadership Qualities:** (paragraph with multiple sentences). We'll keep as prose or list? It's a paragraph describing qualities. Could be
.
**The Ideal Candidate will have:** list of items (each separated by period). We'll make
- .
**Nice to Have:** list of items.
**About Generate Biomedicines:** paragraph.
**Compensation:** includes base salary range, annual bonus, equity compensation, competitive benefits package. Also "Per Year Salary Range $210,000—$290,000 USD". We'll make Pay section with that info. Benefits section: mention annual bonus, equity compensation, competitive benefits package. Could combine? But we have separate Benefits and Pay headings. Pay: salary range. Benefits: bonus, equity, benefits package.
Schedule: none -> omit.
Now ensure we don't include boilerplate: EEO statement, recruitment agency statement, etc. Remove.
Now produce HTML.
Structure:
About the role
...
Responsibilities
- Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments.
- Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management.
- Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory Affairs, Supply Chain, executive leadership, and cross-functional teams on product quality, supply continuity, regulatory readiness, and business objectives.
- Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners.
- Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation.
- Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management activities.
- Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities.
- Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch review and release, deviations, investigations, OOS/OOT results, CAPAs, change controls, product disposition, and other significant quality events.
- Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements, and Generate standards.
- Support global regulatory submissions and health authority interactions by developing and reviewing CMC/QC Quality content, assessing data and control strategies, and supporting responses to regulatory questions.
- Establish and monitor Quality performance indicators, identify evolving regulations and industry pr
Note: last item truncated: "identify evolving regulations and industry pr" maybe cut off. We need to preserve as is? The posting cut off: "identify evolving regulations and industry pr". Probably meant "industry practices". We'll keep as given.
Now Requirements:
Requirements
- Bachelors degree in a relevant scientific discipline and 15+ years of biopharmaceutical industry experience
- Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP operations.
- Strong understanding of quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, data integrity, and inspection readiness.
- Experience providing quality oversight across preclinical, CMC, clinical manufacturing, quality control, supply chain, and product lifecycle activities.
- Strong knowledge of biologic products regulations, process validation, method validation, stability, comparability, specifications, and control strategies.
- Proven ability to establish phase-appropriate Quality strategies and scalable systems for early- and late-stage development programs.
- Significant quality oversight experience working with CDMOs, CROs, contract testing laboratories, suppliers, and other external partners.
- Experience leading audits, quality agreements, partner performance management, investigations, remediation, and risk mitigation.
- Demonstrated success supporting regulatory submissions, health authority interactions, inspections, and responses to regulatory findings.
- Experience partnering with Technical Operations, Preclinical, Regulatory, Clinical, Manufacturing, and Supply Chain teams.
- Proven ability to build, mentor, develop and lead high performing Quality Teams
- Excellent communication and influencing skills, with the ability to explain complex scientific, regulatory, and quality matters to executive leadership and external stakeholders.
- A strategic, proactive, and hands-on leader who anticipates risk, makes sound decisions, and holds teams and partners accountable.
- Commitment to patient safety, product quality, data integrity, compliance, and continuous improvement.
Now Qualifications: maybe Leadership Qualities paragraph.
Qualifications
Brings deep GMP, GLP, manufacturing, and regulatory expertise with sound judgment, business partnership, and strong people leadership. Sets a clear Quality vision while remaining engaged in critical operational issues and making timely, well-reasoned decisions. Identifies and prioritizes compliance and product risks, maintaining Quality’s objectivity and challenging decisions when patient safety, data integrity, or regulatory compliance may be compromised. Provides practical, timely, and science-based guidance that enables development progress while protecting product quality, participant safety, data reliability, and regulatory integrity. Builds trust and alignment across Technical Operations, Preclinical, Regulatory, Clinical, Supply Chain, and internal and external partners through credibility, listening, diplomacy, and consistency. Creates a culture in which Quality is owned across the organization, while maintaining strong oversight of documentation, data integrity, systems, and remediation commitments. Develops fit-for-purpose Quality systems that support growth without unnecessary complexity, using metrics, lessons learned, and root-cause thinking to strengthen processes and prevent recurrence. Provides day-to-day leadership to Quality contractors and other team members; may assume broader people-management responsibilities as the organization grows
Now Skills: Nice to Have list.
Skills
- Involvement in pre-approval inspections, regulatory inspections, and commercialization readiness for biologics.
- Exposure to highly outsourced or virtual biotechnology operating model.
- Involved in implementing new quality technologies, electronic systems, automation, or data-driven quality tools
- Global experience with health authorities, suppliers, and development or manufacturing partners.
- Strategic Quality and GMP leadership for combination drug product development
Now Benefits:
Benefits
Eligible for an annual bonus, equity compensation, and a competitive benefits package.
Now Pay:
Pay
Per Year Salary Range $210,000—$290,000 USD
We also have About Generate Biomedicines paragraph. Could be part of About the role? But we already have About the role. Could add another section "About the Company" but not in allowed headings list. The allowed headings are About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should incorporate company description maybe under About the role? But About the role already defined. Could we add another section like "About the Company"? Not allowed. Maybe we can incorporate it into About the role as additional paragraph. However the instruction: "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., not exclusive. But they say "include a section ONLY when the posting has real, specific content for it". So we could add a section "About the Company" if we want, but not in the list. Safer to stick to the given headings. We could put company description under About the role as a second paragraph.
Thus About the role will have two paragraphs: first the role overview, second company description.
Let's craft About the role:
The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality.
Generate Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty,
for prose. We must not include sections with filler like "commensurate with experience". Not present. We need to decide what goes where. Section "About the role": could be the introductory paragraph: "The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality." That's substantive. Section "Responsibilities": the list after "Here's how you will contribute:" includes many bullet-like sentences. We'll turn each sentence into
. **The Ideal Candidate will have:** list of items (each separated by period). We'll make
- .
**Nice to Have:** list of items.
**About Generate Biomedicines:** paragraph.
**Compensation:** includes base salary range, annual bonus, equity compensation, competitive benefits package. Also "Per Year Salary Range $210,000—$290,000 USD". We'll make Pay section with that info. Benefits section: mention annual bonus, equity compensation, competitive benefits package. Could combine? But we have separate Benefits and Pay headings. Pay: salary range. Benefits: bonus, equity, benefits package.
Schedule: none -> omit.
Now ensure we don't include boilerplate: EEO statement, recruitment agency statement, etc. Remove.
Now produce HTML.
Structure:
About the role
...
Responsibilities
- Establish and maintain a scalable, risk-based GxP Quality framework covering analytical testing, manufacturing, technology transfer, validation, product lifecycle management, and regulatory commitments.
- Provide independent, phase-appropriate Quality oversight of CMC and analytical strategies, including control strategies, CQAs, CPPs, specifications, method development and validation, comparability, stability, reference standards, and lifecycle management.
- Serve as an enterprise Quality leader and strategic advisor to Technical Operations, Regulatory Affairs, Supply Chain, executive leadership, and cross-functional teams on product quality, supply continuity, regulatory readiness, and business objectives.
- Build a culture of quality, accountability, scientific rigor, collaboration, and proactive risk management across Generate and its external partners.
- Lead Generate’s CMC Quality relationships with CDMOs, contract testing laboratories, and other technical partners, including qualification, quality agreements, governance, performance management, audits, and issue escalation.
- Provide Quality oversight of outsourced development, manufacturing, testing, packaging, and storage activities, ensuring compliant and timely execution of clinical supply, GMP release, stability, validation, and lifecycle management activities.
- Provide Quality leadership across technology transfer, scale-up, process characterization, manufacturing changes, comparability, continued process verification, and other product and process lifecycle activities.
- Review and approve key GMP and regulatory documentation, and provide quality leadership for manufacturing campaigns, batch review and release, deviations, investigations, OOS/OOT results, CAPAs, change controls, product disposition, and other significant quality events.
- Drive product quality risk management, audit and inspection readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements, and Generate standards.
- Support global regulatory submissions and health authority interactions by developing and reviewing CMC/QC Quality content, assessing data and control strategies, and supporting responses to regulatory questions.
- Establish and monitor Quality performance indicators, identify evolving regulations and industry pr
Requirements
- Bachelors degree in a relevant scientific discipline and 15+ years of biopharmaceutical industry experience
- Extensive GxP quality leadership experience supporting biologics development, including GMP and GLP operations.
- Strong understanding of quality systems, including deviations, investigations, CAPAs, change controls, OOS/OOT management, data integrity, and inspection readiness.
- Experience providing quality oversight across preclinical, CMC, clinical manufacturing, quality control, supply chain, and product lifecycle activities.
- Strong knowledge of biologic products regulations, process validation, method validation, stability, comparability, specifications, and control strategies.
- Proven ability to establish phase-appropriate Quality strategies and scalable systems for early- and late-stage development programs.
- Significant quality oversight experience working with CDMOs, CROs, contract testing laboratories, suppliers, and other external partners.
- Experience leading audits, quality agreements, partner performance management, investigations, remediation, and risk mitigation.
- Demonstrated success supporting regulatory submissions, health authority interactions, inspections, and responses to regulatory findings.
- Experience partnering with Technical Operations, Preclinical, Regulatory, Clinical, Manufacturing, and Supply Chain teams.
- Proven ability to build, mentor, develop and lead high performing Quality Teams
- Excellent communication and influencing skills, with the ability to explain complex scientific, regulatory, and quality matters to executive leadership and external stakeholders.
- A strategic, proactive, and hands-on leader who anticipates risk, makes sound decisions, and holds teams and partners accountable.
- Commitment to patient safety, product quality, data integrity, compliance, and continuous improvement.
Qualifications
Brings deep GMP, GLP, manufacturing, and regulatory expertise with sound judgment, business partnership, and strong people leadership. Sets a clear Quality vision while remaining engaged in critical operational issues and making timely, well-reasoned decisions. Identifies and prioritizes compliance and product risks, maintaining Quality’s objectivity and challenging decisions when patient safety, data integrity, or regulatory compliance may be compromised. Provides practical, timely, and science-based guidance that enables development progress while protecting product quality, participant safety, data reliability, and regulatory integrity. Builds trust and alignment across Technical Operations, Preclinical, Regulatory, Clinical, Supply Chain, and internal and external partners through credibility, listening, diplomacy, and consistency. Creates a culture in which Quality is owned across the organization, while maintaining strong oversight of documentation, data integrity, systems, and remediation commitments. Develops fit-for-purpose Quality systems that support growth without unnecessary complexity, using metrics, lessons learned, and root-cause thinking to strengthen processes and prevent recurrence. Provides day-to-day leadership to Quality contractors and other team members; may assume broader people-management responsibilities as the organization grows
Now Skills: Nice to Have list.Skills
- Involvement in pre-approval inspections, regulatory inspections, and commercialization readiness for biologics.
- Exposure to highly outsourced or virtual biotechnology operating model.
- Involved in implementing new quality technologies, electronic systems, automation, or data-driven quality tools
- Global experience with health authorities, suppliers, and development or manufacturing partners.
- Strategic Quality and GMP leadership for combination drug product development
Benefits
Eligible for an annual bonus, equity compensation, and a competitive benefits package.
Now Pay:Pay
Per Year Salary Range $210,000—$290,000 USD
We also have About Generate Biomedicines paragraph. Could be part of About the role? But we already have About the role. Could add another section "About the Company" but not in allowed headings list. The allowed headings are About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should incorporate company description maybe under About the role? But About the role already defined. Could we add another section like "About the Company"? Not allowed. Maybe we can incorporate it into About the role as additional paragraph. However the instruction: "Usefor section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It says e.g., not exclusive. But they say "include a section ONLY when the posting has real, specific content for it". So we could add a section "About the Company" if we want, but not in the list. Safer to stick to the given headings. We could put company description under About the role as a second paragraph. Thus About the role will have two paragraphs: first the role overview, second company description. Let's craft About the role:
The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners, and ensure the company’s products and processes meet applicable regulatory, GxP, and company requirements. This is a hands-on individual contributor leadership role that will partner closely with Technical Operations, Regulatory Affairs, Clinical Development, Supply Chain, external vendors, and internal company stakeholders to support programs from development through commercialization. This role will report to the Vice President, Head of Quality.
Generate Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty,