Job Posting Title:Associate Director, Quality Assurance Requisition Number: 4010
Country: US
State: California
Job Location: Foster City
Functional Area: QA/QC
Position Type: Regular
Shift: Days
Specific Responsibilities:
Gilead Sciences is currently seeking an Associate Director, Quality Assurance. In this role the successful candidate will be responsible for the selection and/or approval of contract drug product manufacturers. They will work with operations staff to affect the transfer, validation and on-going Support of commercial product quality at contract Manufacturing organizations.
Essential Duties and Job Functions:
• Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls as they pertain to commercial drug product Manufacturing at contract Manufacturing organizations (CMOs).
• Supports the operations group in the evaluating and selecting potential CMOs.
• Provides quality experience in the transfer of drug product Manufacturing to CMOs.
• Provides initial validation assessment of equipment, systems, and processes and as needed. Develops and tracks quality metrics related to validations.
• Reviews and approves procedures, production records and specification in Support of technology transfers to CMOs.
• Evaluates and approves Engineering and process changes at CMOs.
• Ensures that performance and quality attributes of products conform to established standards and agency requirements to ensure regulatory compliance and customer satisfaction. Assists Gilead product release group in the resolution of deviations, OOT/OOS and other non-conformances at CMOs.
• Supports Quality Systems department in compilation of Annual Quality Reports for drug product manufactured at CMOs.
• Establishes and ensures CMOs achieve the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of Key Performance Indicators (KPI’s). .
• Establishes and ensures policy at the CMOs for the adherence to CFR, EMEA, and all other Government agencies.
• Represents the department on cross-functional project teams.
• Ability to work with commercial, regulatory, and most corporate functions.
• Works independently to resolve issues with very limited direct supervision.
Knowledge, Experience and Skills:
• Typically requires a BA or BS degree and a minimum of 12 years of operational quality and Manufacturing experience in a Pharmaceutical or biotech environment or an MA or MBA degree and minimum 10 years of relevant experience.
• Prior experience related to managing quality systems in the tech transfer; scale up, validation and CMO management areas is a must.
• Experience in launching and managing commercial Pharmaceutical products is a must.
• Must have expertise in U.S., EU and international GMPs. Must understand standards of practice for the manufacture of solid dosage form, aseptic solution and other non-sterile dosage preparations.
• Must have previous experience in supervision of staff, setting individual goals and objectives and preparing performance based reviews
• Must be able to develop and improve concepts, techniques, and standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. Challenges are unique and solutions may serve as precedent for future decisions.
• Must be able to interpret, execute, and recommend modifications to policies to achieve department goals and objectives.
• Must be able to influence and direct work through individuals within Gilead and at CMOs outside of their direct supervision.
