General Summary:
The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality operations, supports the execution of new initiatives, and applies sound judgment to resolve complex quality and compliance issues. The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity.
This role serves as a visible Quality partner to Product Quality Leads, MSAT, Regulatory Affairs, operational stakeholders, CDMOs, and suppliers. The successful candidate will be a key member of the Vertex Biologics and Devices Quality Team, influencing cross-functional alignment, proactively managing risk, and providing timely quality direction in support of external drug substance manufacturing and disposition.
Key Duties and Responsibilities:
- Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT, Regulatory Affairs, and other Quality functions to resolve complex deviations and align decisions with patient safety, product quality, and regulatory compliance
- Represent Quality on cross-functional teams as a senior technical resource and decision-maker
- Lead drafting, negotiation, and oversight of Quality Agreements with CDMOs, suppliers, and Vertex, as needed
- Provide Quality oversight and direction to Change Control owners to ensure compliance with procedural and regulatory expectations
- Initiate, assess, and approve change controls, as appropriate, using risk-based decision-making
- Provide Quality leadership and technical expertise for deviation investigations, including OOS/OOT events, by ensuring robust root cause analysis and timely, effective CAPA implementation
- Review and approve complex investigations and CAPAs to ensure scientific rigor, compliance, and sustainable corrective actions
- Review and approve master and executed batch records to support external drug substance disposition activities
- Analyze Quality Metrics and performance trends to identify risks, drive continuous improvement, and inform Quality leadership decisions
- Develop and recommend strategies to address compliance gaps and strengthen cross-functional quality systems
- Lead or contribute to operational review and escalation meetings to ensure Quality issues are appropriately prioritized, assessed, escalated, and resolved for external drug substance manufacturing operations
- Drive completion of assigned QLT action items by coordinating stakeholders, clarifying expectations, and ensuring timely follow-through
- Proactively identify, assess, communicate, and mitigate quality and compliance risks across assigned programs and external manufacturing activities
- Provide technical Quality guidance during partner and regulatory agency audits
- Review regulatory submissions, as needed, to ensure technical accuracy, clarity, and alignment with current regulatory expectations
- Drive Quality readiness for major development milestones including IND/IMPD submissions, clinical supply manufacturing, PPQ, and regulatory inspections
- Ensure quality risks are proactively identified and escalated within program governance
Knowledge and Skills:
- In-depth knowledge of cGMP principles and their practical application in a biologics pharmaceutical setting, including global GMP manufacturing requirements
- Demonstrated leadership and influence across matrixed teams, with the ability to set direction, drive accountability, and deliver quality outcomes in a fast-paced environment
- Experience leading complex quality initiatives with contract manufacturing organizations, including cross-functional planning, issue escalation, stakeholder alignment, and continuous improvement
- Advanced experience identifying, assessing, communicating, and mitigating quality and compliance risks using quality risk management principles and sound business judgment
- Ability to mentor and coach less experienced colleagues, build technical capability, and model effective quality decision-making
- Excellent communication and influencing skills, including the ability to translate complex and sensitive quality issues into clear recommendations for cross-functional and external audiences
- Demonstrated ability to operate independently, exercise sound judgment, and provide quality leadership for large, multifaceted projects
- Demonstrated ability to evaluate complex quality matters, make risk-based decisions, synthesize diverse information, and shape practical solutions
- Experience leading complex event investigations, root cause analysis, CAPA strategy, and effectiveness assessments
- Experience with electronic document management systems, such as QDocs, TrackWise, and Veeva
Education and Experience:
- Bachelor's degree in a scientific or allied health field (or equivalent degree)
- Typically requires 8+ years of relevant GMP Quality experience, including leadership of complex quality initiatives and QA oversight of external manufacturing operations
