Job Posting Title:Senior Director, Quality Assurance Requisition Number: 3223
Country: US
State: California
Job Location: Foster City
Functional Area: QA/QC
Position Type: Regular
Shift: Days
Specific Responsibilities:
We are seeking a seasoned Quality Assurance Executive with experience in global Manufacturing operations and in-depth knowledge of regulatory/compliance requirements. This role will be responsible for administrating standards of quality practices that encompass an integrated multi-national organization of external CMO’s and internal Manufacturing locations. This Quality professional will need to interact with all levels of the organization on global policy and guidance for the Manufacturing and global distribution of Biopharmaceutical products. The candidate will need to balance the requirements from a quality perspective of Manufacturing internal produced products versus the utilization of a broad portfolio of third party contract manufacturers. International expertise of GMP’s across multiple business functions though harmonization of procedures and best practices.
Essential Duties and Job Functions:
• Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. Will serve as liaison between the company and the various governmental agencies.
• Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• Establishes and ensures business partners achieve the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI’s. .
• Establishes and ensures policy throughout the commercial Manufacturing enterprise for the adherence to CFR, EMEA, and all other Government agencies in which business is conducted.
• Direct quality systems as they pertain to the technical transfer from late stage development through NDA approval and commercial scale. Ensure ongoing validated state of all commercial product.
• Ability to work with commercial, regulatory, and most corporate functions.
• Lead a group of 14 Quality Assurance professionals.
Knowledge, Experience and Skills:
• Typically requires a BA or BS degree and a minimum of 15+ years of operational quality and Manufacturing experience in a Pharmaceutical or biotech environment. An advanced degree in science or business administration is desired.
• Must be able to develop and improve advanced concepts, techniques, and standards and new applications based on quality principles and theories.
• Must be able to develop solutions to problems of unusual complexity, which require a high degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions which effect the entire organization.
• Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives.
• Must have in-depth expertise in U.S., EU and international GMPs. Must understand standards of practice for the manufacture of API, solid dosage form, aseptic solution and other non-sterile dosage preparations.
• Must have effective communication skills and the ability to deal across several multi-national agencies and organizations.
• Establishes and communicates vision, focus and direction to align organizational and individual action and achieve results. Creates a “learning” culture that enables individuals to reach their maximum potential and builds the capability of the organization. Effectively manages talent to strengthen Gilead. Creates an exceptional working environment that motivates high performance. Communicates a clear vision and expectations that create energy, enthusiasm and commitment from others.
