Job Description
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…