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 cureently seeking an Associate Director, Quality Assurance. In this role the successful candidate will:
Manage QA Personnel responsible for product release and product technical complaints to include organizing and prioritizing group tasks, performing training, and writing performance reviews. Perform a wide variety of activities to ensure compliance with quality systems, quality procedures and applicable regulatory requirements. Develop implements and maintains programs and processes to ensure high quality products and compliance with Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Approve manufacturing, environmental monitoring and quality control data for in-process and finished products.
Responsibilities include final release for commercial manufactured products. Works directly with operating entities to ensure that inspections, statistical process control analyses are conducted on a continuing basis as specified to enforce requirements and meet specifications. Interfaces with contract manufactures to establish relationships for quality oversight and inter-company effectively communication to address documentation and compliance issues. May interface with regulatory agencies as required. May write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Provides QA oversight of deviations, CAPA and Complaint Management programs. Conducts and serve as a lead /coordinator of investigations and Corrective and Preventive actions. Ensure timely review and approval of deviation reports/CAPA plans/Product Complaints to facilitate product release and to demonstrate compliance to governing regulations and Gilead’s internal procedures. Provide QA guidance on root cause analysis. Provide guidance to deviation initiators and investigation leads on information necessary to Support the DR evaluation. Develops and tracks quality metrics related to product release, deviations, CAPAs and Product Complaints. Provides validation assessment on validation of equipment, systems, processes, and methods. Develops and tracks quality metrics related to validations. Works independently to resolve complex issues with very limited direct supervision. Evaluates and approves Engineering and process changes at CMOs. Supports Quality Systems department in compilation of Annual Quality Reports. Represents the department on cross-functional project teams.
Essential Duties and Job Functions:
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality. Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products. Responsibilities may include the final release for all manufactured products. 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. May participate in the writing of annual product reviews and the development of Training programs regarding all aspects of producing quality products. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes. May lead compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues. May interface with regulatory agencies as required. Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Knowledge, Experience and Skills:
Requires an in depth understanding and application of GMP Pharmaceutical manufacturing and quality assurance principles, concepts, practices, and standards. Must be able to work on problems ranging from semi-routine to moderately complex where analysis of situations or data requires in-depth evaluation of various factors. Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results, resolving problems, and/or making recommendations.
