QA Manager (GCP) - Zachary Piper LLC

Piper Health & Sciences is seeking a full-time QA Manager, GCP Auditing to join a mid-size CRO in the Washington, DC area. This is a hybrid position with up to 30% travel required (domestic/international).

Responsibilities for the QA Manager include:

·       Conduct domestic and/or international clinical site audits ensure regulatory and protocol compliance.

·       Review clinical audit reports and communicate results.

·       Contribute to the development of audit inspection readiness program.

·       Act as internal Subject Matter Expert (SME) for clinical quality, providing training and guidance.

·       Host client audits and regulatory inspections, conduct external site audits, conduct vendor audits, and lead CAPA investigations.

Qualifications for the QA Manager include:

·       2+ years of GCP auditing experience at a pharmaceutical/biotech organization or CRO.

·       Proficiency with eQMS (Quality Management Systems).

·       Ability to travel 20%-30% domestically and/or internationally.

·       Certified Quality Auditor (CQA) certification is preferred, but not required.

·       Bachelor’s degree in Life Sciences, Biotechnology, or similar field is required.

Compensation for the QA Manager includes:

·       Salary range: approximately $115,000 - $130,000 annually, commensurate with experience

·       Comprehensive Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays, STD, LTD, Sick leave as required by law, hybrid schedule

This job opens for applications on 12/19/2024. Applications for this job will be accepted for at least 30 days from the posting date.

QA manager, audit manager, gcp, good clinical practice, clinical quality, clinical qa, qa auditor, site audit, vendor audit, site readiness, inspection readiness, fda, ich, regulatory, eqms, qms, investigation, veeva, trackwise, mastercontrol, quality assurance

#LI-CP1

#LI-HYBRID