Job Description

Job Description

Job Description

Remote (U.S.-based preferred)

We are seeking a Quality Assurance (QA) Manager with extensive experience in pharmaceutical QA and a background in CRO environments to join our team on a part-time or contract basis. This role will provide immediate, expert-level support for addressing complex audit findings from pharmaceutical sponsors.

Your role will focus on:

• Collaborating directly with our biopharmaceutical QA teams to address outstanding audit findings.
• Developing and implementing corrective action plans to close identified gaps.
• Providing QA leadership and serving as the primary point of contact for all sponsor-related audit resolution activities.
• Reviewing and enhancing documentation, validation evidence, and QA processes to align with industry standards and sponsor expectations.

Key Qualifications

✅ 5+ years of QA experience within a CRO, pharmaceutical, or biotech environment.
✅ Proven success in managing and resolving complex sponsor audits, including major findings.
✅ Strong knowledge of GCP, ICH guidelines, FDA, and sponsor audit processes.
✅ Hands-on experience with SOPs, validation of electronic systems (e.g., sFTP portals, SAS software), and QA best practices.
✅ Excellent communication skills, especially in liaising with sponsor QA teams.
✅ Ability to work independently, manage priorities, and drive audit resolution to completion.

Position Details

• Part-time or contract-based engagement.
• Remote work; U.S. time zone preferred for better sponsor collaboration.
• Immediate availability highly desired.

Company Description

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