Associate Director, Product Quality (Hybrid)
Vertex Pharmaceuticals
9 hours ago
Remote friendly (Boston, MA)
United States
$151,200 - $226,800 USD yearly
Operations
Product Quality Associate Director responsibilities:
- Provide end-to-end quality oversight for small molecule program(s) across clinical development, commercialization, filing, approval, launch, and post-approval lifecycle management (including decommissioning).
- Set and maintain overall Quality strategies to support commercialization, including establishing product quality standards for current/novel technologies (including devices where applicable).
- Ensure QA and cross-functional alignment with industry and regulatory expectations.
- Identify product quality risks and develop/execute mitigations across the development lifecycle through commercialization and decommissioning.
- Partner with development functions (process development, analytical development, manufacturing science/technology, site QA/QC, regulatory CMC) and commercial functions (AS&T, MS&T, QC, QA Operations, Supply Chain) to enable a QbD approach aligned with technical, regulatory, and cGMP compliance needs.
- Ensure robust supply chain support and product launch readiness per program needs.
Key duties & responsibilities:
- Define Quality expectations, strategy, and deliverables for assigned program(s), including in-licensed and outsourced products.
- Develop, approve, and maintain critical Quality standards and control requirements (e.g., stage gate deliverables, product specifications, stability program development) and keep quality/compliance systems current with industry and health authority expectations and the Vertex QMS.
- Critically evaluate new products/processes for Quality and compliance; improve manufacturing processes, new product introduction standards, and program strategy; integrate clinical phase-appropriate approaches.
- Proactively identify Quality risks and improvement opportunities across manufacturing stages and drug product presentations; ensure risks/mitigations are understood and executed during clinical development, validation, submission, and launch.
- Support post-approval changes driven by continuous improvement, regulatory requirements/commitments, geo-expansion, or business needs.
- Escalate significant Quality risks per procedure and ensure timely mitigation with cross-functional/site teams.
- Champion consistent Quality-by-Design and compliance standards, including implementation of new/emerging regulatory guidance.
- Serve as Quality point of contact for new product introduction and PAI readiness on relevant CMC governance teams (Analytical Development, Process Development, Technical Operations, Supply Chain).
- Represent Quality at governance meetings; review product strategy using a risk-based approach.
- Act as project manager within Quality to facilitate multi-directional communication and standardized processes (e.g., new product introduction, risk assessments, technology transfers).
- Review and approve CMC clinical/commercial regulatory submission documents and support device development for combination products (as needed), including design history file reviews, risk identification, and mitigation.
- Define resource allocation for QA resource assignment for assigned products.
Education & experience:
- Bachelor’s or Master’s degree in a Scientific/Technical/Business discipline.
- Minimum 8 years of deep and broad experience in technical, quality, and/or regulatory roles in pharmaceutical/biopharmaceutical product development with project management and governance.
- Preferred expertise: DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring.
- Preferred: at least 3 years managing staff and/or leading cross-functional teams/projects/programs or directing resource allocation (Site Leadership Team or R&D Leadership Team experience strongly preferred).
Required knowledge/skills:
- Expertise in cGMP compliance, FDA guidelines, and international guidelines for pharmaceutical manufacturing and Quality Assurance.
- Demonstrated application of cGMP and Quality Assurance principles.
- Experience implementing 21st century cGMP guidance; ICH Q8/9/10/11; PAT/ASTM guidance; deep understanding of quality systems/processes (change control, event handling, CAPA), risk management, and manufacturing control strategies.
- Direct regulator experience (e.g., NDA, BLA, MAA submissions and/or inspections).
- Proven leadership in making difficult decisions logically and serving as a senior management team member.
- Influential leadership in a matrix organization across Technical, Supply Chain, and Regulatory functions (presenting, influencing, negotiating, partnering; building alignment).
- Strategic thinking and strong project management with focus on execution.
- Experience in technology transfer, process development and/or process validation.
Preferred skills/experience are embedded in the education/experience section above.
- Provide end-to-end quality oversight for small molecule program(s) across clinical development, commercialization, filing, approval, launch, and post-approval lifecycle management (including decommissioning).
- Set and maintain overall Quality strategies to support commercialization, including establishing product quality standards for current/novel technologies (including devices where applicable).
- Ensure QA and cross-functional alignment with industry and regulatory expectations.
- Identify product quality risks and develop/execute mitigations across the development lifecycle through commercialization and decommissioning.
- Partner with development functions (process development, analytical development, manufacturing science/technology, site QA/QC, regulatory CMC) and commercial functions (AS&T, MS&T, QC, QA Operations, Supply Chain) to enable a QbD approach aligned with technical, regulatory, and cGMP compliance needs.
- Ensure robust supply chain support and product launch readiness per program needs.
Key duties & responsibilities:
- Define Quality expectations, strategy, and deliverables for assigned program(s), including in-licensed and outsourced products.
- Develop, approve, and maintain critical Quality standards and control requirements (e.g., stage gate deliverables, product specifications, stability program development) and keep quality/compliance systems current with industry and health authority expectations and the Vertex QMS.
- Critically evaluate new products/processes for Quality and compliance; improve manufacturing processes, new product introduction standards, and program strategy; integrate clinical phase-appropriate approaches.
- Proactively identify Quality risks and improvement opportunities across manufacturing stages and drug product presentations; ensure risks/mitigations are understood and executed during clinical development, validation, submission, and launch.
- Support post-approval changes driven by continuous improvement, regulatory requirements/commitments, geo-expansion, or business needs.
- Escalate significant Quality risks per procedure and ensure timely mitigation with cross-functional/site teams.
- Champion consistent Quality-by-Design and compliance standards, including implementation of new/emerging regulatory guidance.
- Serve as Quality point of contact for new product introduction and PAI readiness on relevant CMC governance teams (Analytical Development, Process Development, Technical Operations, Supply Chain).
- Represent Quality at governance meetings; review product strategy using a risk-based approach.
- Act as project manager within Quality to facilitate multi-directional communication and standardized processes (e.g., new product introduction, risk assessments, technology transfers).
- Review and approve CMC clinical/commercial regulatory submission documents and support device development for combination products (as needed), including design history file reviews, risk identification, and mitigation.
- Define resource allocation for QA resource assignment for assigned products.
Education & experience:
- Bachelor’s or Master’s degree in a Scientific/Technical/Business discipline.
- Minimum 8 years of deep and broad experience in technical, quality, and/or regulatory roles in pharmaceutical/biopharmaceutical product development with project management and governance.
- Preferred expertise: DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring.
- Preferred: at least 3 years managing staff and/or leading cross-functional teams/projects/programs or directing resource allocation (Site Leadership Team or R&D Leadership Team experience strongly preferred).
Required knowledge/skills:
- Expertise in cGMP compliance, FDA guidelines, and international guidelines for pharmaceutical manufacturing and Quality Assurance.
- Demonstrated application of cGMP and Quality Assurance principles.
- Experience implementing 21st century cGMP guidance; ICH Q8/9/10/11; PAT/ASTM guidance; deep understanding of quality systems/processes (change control, event handling, CAPA), risk management, and manufacturing control strategies.
- Direct regulator experience (e.g., NDA, BLA, MAA submissions and/or inspections).
- Proven leadership in making difficult decisions logically and serving as a senior management team member.
- Influential leadership in a matrix organization across Technical, Supply Chain, and Regulatory functions (presenting, influencing, negotiating, partnering; building alignment).
- Strategic thinking and strong project management with focus on execution.
- Experience in technology transfer, process development and/or process validation.
Preferred skills/experience are embedded in the education/experience section above.