Director, QC Product Readiness
About The Position
The Director, Quality Control Product Readiness leads the organization of QC Leads responsible for assigned commercial products and programs. The role establishes direction, governance, expectations, and resource priorities for the QC Lead function, ensuring consistent oversight of product readiness, analytical lifecycle activities, and transition from clinical to commercial QC. This leader coaches and develops the QC Leads, removes barriers, resolves cross-program issues, and serves as the escalation point in commercial QC. Focus Areas: Product Readiness and Portfolio Execution Oversee clinical-to-commercial QC transitions and ongoing product readiness, ensuring clear criteria, stakeholder alignment, sustainable ownership, and resolution of readiness gaps. Manage portfolio priorities, testing capacity, resources, and execution risks; escalate systemic issues and sponsor recovery plans to support uninterrupted product supply. Analytical and Regulatory Lifecycle Oversight Provide technical guidance and decision frameworks for complex analytical issues, investigations, methods, specifications, reference standards, documentation, and related readiness gaps. Ensure scientifically sound health authority responses and governance of post-approval changes and regulatory commitments through implementation and closure. Leadership and Cross-Functional Partnership Build, lead, mentor, and develop a high-performing team of QC Leads responsible for product readiness and analytical lifecycle oversight. Define the QC Lead operating model, role expectations, decision rights, performance standards, and development pathways. Ensure appropriate assignment and capacity of QC Leads across the portfolio based on program complexity, risk, and business priorities. Establish scalable standards, metrics, and continuous improvement practices that strengthen consistency, product readiness, compliance, and execution across the QC Lead organization. Contribute to department strategy, workforce and resource planning, budgeting, succession planning, and long-range capability development.
Requirements
- BS degree with 12+ years of relevant experience, MS degree with 10+ years of relevant experience, or PhD with 2+ years of relevant experience in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or a related field.
- Significant experience in pharmaceutical or biopharmaceutical Quality Control, including leadership of technical professionals responsible for commercialization, product lifecycle management, or external laboratory oversight.
- Demonstrated ability to lead and develop product-focused QC Leads, establish governance and operating standards, balance portfolio priorities, and drive accountability through others.
- Broad technical knowledge of analytical method validation and transfer, method lifecycle management, commercial specifications, laboratory investigations, sample management, and testing logistics.
- Experience providing leadership oversight for QC-related BLA or NDA content and responses to health authority questions.
- Strong knowledge of cGMP principles, data integrity expectations, and applicable global regulatory requirements for commercial analytical testing.
- Proven ability to influence senior cross-functional stakeholders, resolve complex escalations, manage competing portfolio priorities, and make risk-based decisions in ambiguous environments.
- Excellent scientific judgment, people leadership, coaching, organizational, written communication, and presentation skills.
Responsibilities
- Oversee clinical-to-commercial QC transitions and ongoing product readiness, ensuring clear criteria, stakeholder alignment, sustainable ownership, and resolution of readiness gaps.
- Manage portfolio priorities, testing capacity, resources, and execution risks; escalate systemic issues and sponsor recovery plans to support uninterrupted product supply.
- Provide technical guidance and decision frameworks for complex analytical issues, investigations, methods, specifications, reference standards, documentation, and related readiness gaps.
- Ensure scientifically sound health authority responses and governance of post-approval changes and regulatory commitments through implementation and closure.
- Build, lead, mentor, and develop a high-performing team of QC Leads responsible for product readiness and analytical lifecycle oversight.
- Define the QC Lead operating model, role expectations, decision rights, performance standards, and development pathways.
- Ensure appropriate assignment and capacity of QC Leads across the portfolio based on program complexity, risk, and business priorities.
- Establish scalable standards, metrics, and continuous improvement practices that strengthen consistency, product readiness, compliance, and execution across the QC Lead organization.
- Contribute to department strategy, workforce and resource planning, budgeting, succession planning, and long-range capability development.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Director
