Gilead Sciences is currently seeking an Associate Director QA - Quality Systems for a newly created position within the Pharmaceutical Manufacturing and Development (PDM) organization in Foster City, CA.
• Manage the Deviation and CAPA program and conduct effectiveness assessments
• Oversee the generation of Quality Systems metrics and prepare periodic Management Review reports for PDM management
• Manage improvements and maintenance of Quality Management Systems
• Provide QA oversight of equipment/instruments qualifications and associated software validations and apply risk based methodology
• Provide QA assessment and approval for facility changes and engineering change orders
• Participate as the PDM representative on global quality systems project teams
• Lead cross-functional improvement projects and promote a culture of quality
• Provide oversight of the QA GMP Warehouse activities
• Review and revise SOPs for consistency and compliance with regulatory requirements
• Support regulatory inspections by FDA and foreign regulatory agencies
• Must have strong knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks
• Extensive experience with implementation/improvement of quality systems
• Experience in developing and generating quality system metrics/trending
• Strong working knowledge of risk based commissioning and qualification
• Experience providing oversight of implementing and maintaining GXP computer systems in a validated state including meeting Part 11 and EU Annex 11 requirements
• Working knowledge of risk management tools and Failure Mode Effects Analysis (FMEA)
• Experience with small molecule drugs, biologics and devices is a plus
• Excellent communication skills including the ability to effectively communicate across organizational levels and functions
• Facilitate open communication and sharing of knowledge
• Demonstrated ability to perform in a fast paced environment and create an exceptional working environment that motivates high performance
Essential Duties and Job Functions:
Manages QA personnel, to include organizing and prioritizing group tasks, performing training, and writing performance reviews. Performs a wide variety of activities to ensure compliance with quality systems, quality procedures and applicable regulatory requirements. Develops, implements and maintains programs and processes to ensure compliance with Current Good Manufacturing Practices (cGMPs). May assist or lead compliance audits as required. May interface with regulatory agencies as required. Writes and implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Develops budgets and monitors expenditures. 5 % travel is required.
Knowledge, Experience and Skills:
Typically requires a BA or BS and minimum 12 years of relevant progressive experience in the pharmaceutical industry in a GMP quality (QA/QC) environment (or a MS or MBA degree and minimum 10 years of relevant experience). 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 corporate goals and objectives. Excellent verbal, technical writing and interpersonal communication skills are required.
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