QA Project Manager

Eurofins•Upper Gwynedd Township, PA

About The Position

The QA Project Manager serves as a lead auditor, working independently and as part of a team to ensure compliance with GxPs, client policies, international guidelines, and departmental SOPs. The role analyzes quality indicators and data to identify risks and develop risk-management strategies, conducts audits including GLP, BA/BE, and VCA audits, and provides technical support for GLP and regulated laboratory-area issues. The position also contributes to QA procedures, guidance documents, and audit tools; escalates quality issues; participates in root-cause investigations and CAPAs; and supports timely resolution and communication of findings. Additional duties include monitoring regulatory citations, supporting compliance awareness, training QA colleagues, providing inspection-management support, and completing other assignments as directed by management. This is a full-time position, generally Monday through Friday from 8 a.m. to 5 p.m. Weekend work might be expected. Candidates living within commuting distance of West Point, Pennsylvania are encouraged to apply.

Requirements

BS/BA degree in a scientific concentration.
At least 10 years of previous QA experience in the pharmaceutical industry, including experience across a broad range of auditing.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Nice To Haves

Business acumen and a strong understanding of the pharmaceutical industry.
Ability to prioritize and plan projects and establish detailed action plans.
Ability to identify and understand complex problems, analyze them, and seek solutions.
Ability to network and build partnerships across work groups.

Responsibilities

Serve as lead auditor independently and as part of a team to ensure compliance with GxPs, client policies, international guidelines, and departmental SOPs.
Analyze quality indicators and data to identify potential risks and develop risk-management strategies.
Conduct audits, including GLP, BA/BE, and VCA audits.
Provide technical support to resolve GLP or regulated laboratory-area issues.
Participate in developing QA procedures, guidance documents, and audit tools.
Escalate quality issues to leadership in a timely manner and participate in root-cause analysis and CAPAs.
Ensure timely resolution of findings and provide reports to appropriate personnel and leadership.
Monitor regulatory citations and other relevant information and distribute it to personnel; participate in compliance-awareness sessions as needed.
Train other QA colleagues.
Provide inspection-management support as needed.
Complete other projects or assignments as directed by management.