Assoc Director, Outsourced Manufacturing
Gilead Sciences
June 27, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Key Responsibilities
- Execute tactical management of CMOs to ensure Oral Solid Dose (OSD) products are manufactured per registered process and approved Master Production Record.
- Resolve complex manufacturing/compliance issues: deviations, complaints, out-of-specification investigations, Material Review Board, finished product trending, and change control.
- Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal manufacturing sites for technology transfer and validation to assigned CMO(s).
- Drive continuous improvement to reduce cost, improve quality/efficiency, and ensure sustainability.
- Represent manufacturing on cross-functional Development/Commercial CMC teams; manage product strategy across lifecycle (clinical supply → launch → routine supply → divestiture/sunset).
- Evaluate vendors’ operations/capabilities/capacity and negotiate competitive pricing consistent with quality, reliability, and schedules.
- Facilitate production schedules; proactively communicate supply risks and schedule delays.
- Apply knowledge of pharmaceutical GMPs and ICH guidelines.
- Participate in QA-led regulatory/compliance audits as needed.
- Support resource planning and financial reporting.
- Communicate clearly to senior management; manage multiple priorities.
Basic Qualifications
- Bachelor’s (BA/BS) in Organic Chemistry, Chemical Engineering, or related field + 10+ years managing external sites.
OR Master’s degree + 8+ years managing external sites.
- Strong GMP and ICH regulatory knowledge.
- Experience managing external suppliers/CMOs/warehouses/logistics providers.
- Ability to interact with senior management and cross-functional teams.
- Exceptional verbal and written communication.
Preferred Qualifications
- OSD manufacturing and supply chain execution/oversight.
- CMO landscape knowledge.
- cGMP/ worldwide regulatory experience.
- QA partnership for inspections/audits.
- Vendor qualification, contract negotiation, supplier performance management.
Compensation/Benefits (if applicable)
- Salary range: $182,070.00–$235,620.00; may include discretionary bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
- Execute tactical management of CMOs to ensure Oral Solid Dose (OSD) products are manufactured per registered process and approved Master Production Record.
- Resolve complex manufacturing/compliance issues: deviations, complaints, out-of-specification investigations, Material Review Board, finished product trending, and change control.
- Coordinate inter- and intra-company technical transfers; partner with Technical Development and internal manufacturing sites for technology transfer and validation to assigned CMO(s).
- Drive continuous improvement to reduce cost, improve quality/efficiency, and ensure sustainability.
- Represent manufacturing on cross-functional Development/Commercial CMC teams; manage product strategy across lifecycle (clinical supply → launch → routine supply → divestiture/sunset).
- Evaluate vendors’ operations/capabilities/capacity and negotiate competitive pricing consistent with quality, reliability, and schedules.
- Facilitate production schedules; proactively communicate supply risks and schedule delays.
- Apply knowledge of pharmaceutical GMPs and ICH guidelines.
- Participate in QA-led regulatory/compliance audits as needed.
- Support resource planning and financial reporting.
- Communicate clearly to senior management; manage multiple priorities.
Basic Qualifications
- Bachelor’s (BA/BS) in Organic Chemistry, Chemical Engineering, or related field + 10+ years managing external sites.
OR Master’s degree + 8+ years managing external sites.
- Strong GMP and ICH regulatory knowledge.
- Experience managing external suppliers/CMOs/warehouses/logistics providers.
- Ability to interact with senior management and cross-functional teams.
- Exceptional verbal and written communication.
Preferred Qualifications
- OSD manufacturing and supply chain execution/oversight.
- CMO landscape knowledge.
- cGMP/ worldwide regulatory experience.
- QA partnership for inspections/audits.
- Vendor qualification, contract negotiation, supplier performance management.
Compensation/Benefits (if applicable)
- Salary range: $182,070.00–$235,620.00; may include discretionary bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.