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 external manufacturing platforms. Identify compliance risks and effectively communicate findings to appropriate management.
• Maintain the external audit program, including coordination, scheduling and communication with vendors and internal stakeholders, to ensure quality oversight of contract manufacturers, contract laboratories, and suppliers.
• Demonstrate the ability to incorporate sound Risk Management fundamentals in the establishment and adherence of audits conducted across the manufacturing base.
• Promote awareness across the commercial and clinical manufacturing platform of current regulatory agency requirements
• Develop and present auditor training modules to Gilead staff
• 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:
Maintains the external GMP audit program through audit coordination, communications to vendors and internal stakeholders, scheduling, and performance of audits. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. 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. Ensures compliance with current Good Manufacturing Practices (cGMPs). May interface with regulatory agencies as required.
Knowledge, Experience and Skills:
• 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
• Solid understanding of cGxP regulatory standards concepts, including quality oversight of contracted service providers/suppliers, pharmaceutical manufacturing/testing compliance issues, and risk management, as well as current industry practices.
• BA/BS in life science and a minimum of 8 years in the pharmaceutical industry
• Apply excellent verbal communication, clear and concise writing, and strong interpersonal skills to convey compliance issues and assessments with management and external vendors.
Must have an in-depth understanding and be able to apply 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. Exercise judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
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