Senior Manager, Corporate Quality - R&D Audits (GVP)

Shape the Future of Healthcare and Science

Join a growing company dedicated to making a groundbreaking impact in the world of biotechnology. This opportunity offers the chance to oversee vendor management and audit programs with a specific focus on GPV and GLP-GCLP vendor audits, ensuring compliance with global regulatory requirements and driving continuous improvement in quality systems.

Key Responsibilities

• Conduct external audits of approved vendors, including developing audit plans, preparing reports, and escalating findings as needed.
• Perform quality audits for the qualification of new vendors.
• Conduct for-cause audits of external vendors as requested by management.
• Review and evaluate vendor audit responses to ensure compliance with industry standards and guidelines.
• Act as a QA point of contact for vendor-related audits, performance oversight, and compliance decisions.
• Support the maintenance of annual external audit schedules.
• Provide assistance during GxP health authority inspections.
• Revise and create GxP quality documentation, such as SOPs, policies, templates, and work instructions.
• Manage auditing files, records, reports, licenses, and certificates related to the approved vendor program.
• Support the integration of acquired programs.
• Take on additional responsibilities as assigned.

Essential Skills and Requirements

• Degree in Life Sciences or a related field.
• Experience in pharmaceutical or biotech drug development, with expertise in GPV and GLP-GCLP auditing.
• Strong knowledge of OECD Principles on GLP, GPV, ICH E6 GCP Guidelines, FDA regulations, and EU requirements.
• Excellent interpersonal skills, integrity, and the ability to build strong working relationships across teams.
• Willingness to travel domestically and internationally up to 20% of the time.

Compensation

$160,000 to $175,000 per annum.