Director, QC Product Readiness
$210.38k - $272.25kGilead
Gilead Sciences seeks a Director of QC Product Readiness to lead quality control leads overseeing commercial products and programs. The role manages clinical-to-commercial transitions, analytical lifecycle activities, portfolio execution, and team development while ensuring consistent product readiness and regulatory compliance.
Responsibilities
- Oversee clinical-to-commercial QC transitions and manage ongoing product readiness across assigned portfolio
- Lead, mentor, and develop team of QC Leads while defining operating models, role expectations, and performance standards
- Provide technical guidance on analytical issues, regulatory commitments, and post-approval changes
- Manage portfolio priorities, testing capacity, resources, and escalate systemic execution risks
- Contribute to department strategy, workforce planning, budgeting, and long-range capability development
Requirements
- BS in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences or related field with 12+ years experience
- MS degree with 10+ years relevant experience, or PhD with 2+ years experience acceptable
- Significant pharmaceutical or biopharmaceutical QC leadership experience including commercialization and product lifecycle management
- Broad technical knowledge of analytical method validation, transfer, commercial specifications, and cGMP principles
- Experience leading BLA or NDA content and health authority regulatory responses
- Demonstrated ability to lead technical professionals, establish governance, balance priorities, and drive accountability
- Strong cross-functional influence, risk-based decision-making, and people leadership skills
Compensation: $210,375–$272,250 base
$210.38k - $272.25k
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