Job Posting Title:Sr. Manager, QA Compliance Audits Requisition Number: 8130
Country: US
State: Washington
Job Location: Seattle
Functional Area: QA/QC
Position Type: Regular
Shift: Days
Specific Responsibilities:
This is an outstanding opportunity to join Gilead's evolving & progressive Quality Assurance organization.
In this role the successful candidate will:
• Coordinate and perform audits across both internal/external manufacturing platforms. Identify compliance risks and report findings to appropriate management with recommendations for resolution.
• Work directly with operating entities to ensure completion of corrective actions to address compliance concerns identified during audits
• Demonstrate the ability to incorporate sound Risk Management fundamentals in the establishment and adherence of audits conducted across the commercial manufacturing base.
• Participate in the development, implementation and maintenance of programs/ processes to assist in ensuring compliance with current Good Manufacturing Practices (cGMP) expectations
• Maintain audit schedules to ensure quality oversight of contract manufacturers, contract laboratories and internal functions
• Promote awareness across the commercial and clinical manufacturing platform of current regulatory agency requirements
• Develop and present auditor Training modules to Gilead staff and mentor team auditors
• May coordinate and interface with regulatory agencies as required in Support of regulatory agency inspections
• Travel is required up to 30%
Essential Duties and Job Functions:
Manages compliance audits and may manage QA consultants. Leads compliance audits. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality. Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines. Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. 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. Ensures compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). Interfaces with contract manufacturers to address documentation and compliance issues. May interface with regulatory agencies as required.
Knowledge, Experience and Skills:
• Highly skilled auditor with an in-depth understanding of complex international cGMP regulations, guidelines, quality systems and compliance issues and a minimum 5 years of relevant auditing experience
• Must have practical understanding of cGxP regulatory standards concepts, and industry practices.
• BA/BS in life science and a minimum of 10 years in the Pharmaceutical industry
• Excellent verbal, technical writing, and interpersonal communications skills
Must have an in depth understanding and application of principles, concepts, practices, and standards. Must be able to work on problems ranging from moderately complex to complex in scope where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations. Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Excellent verbal, written and interpersonal communication skills are required.
