Senior Manager, Corporate Quality - R&D Audits - Permanent - Remote US
Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
Proclinical is seeking a Senior Manager, Corporate Quality - R&D Audits to oversee vendor management and audit programs with a focus on GPV and GLP-GCLP vendor audits.
Primary Responsibilities:
This role ensures compliance with global regulatory requirements, supports the integration of acquired programs, and drives continuous improvement in quality systems.
Key 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.
The Senior Manager's responsibilities will be:
- 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.
- Take on additional responsibilities as assigned.
Compensation
- $160,000 to $175,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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