Senior Manager, QA - GCP Audit Management

Senior Manager for QA - Permanent - Cambridge, MA

Proclinical is seeking a dedicated Senior Manager for QA in GCP Audit Management.

Primary Responsibilities:

The successful candidate will focus on ensuring compliance with FDA and international regulations for clinical studies. You will be instrumental in vendor risk assessment, audit management, and developing quality metrics. This position offers the opportunity to contribute significantly to inspection readiness and audit coordination.

Skills & Requirements:

• Degree in a scientific discipline; advanced degree preferred.
• Experience in Quality Assurance roles, including GLP/GCP/GVP audits.
• Knowledge of global clinical trial conduct and regulatory guidelines.
• Experience in supporting regulatory authority inspections.
• Strong interpersonal skills and ability to work cross-functionally.
• Willingness to travel up to 25% domestically and internationally.

The Senior Manager for QA's responsibilities will be:

• Plan, prepare, and conduct GLP/GCP/GVP audits for clinical investigators and vendors.
• Develop and update annual audit plans based on risk assessments and trial priorities.
• Record and report audit results, ensuring corrective actions are documented.
• Conduct vendor qualification audits and assess GxP vendors/CRO partners.
• Ensure compliance with quality management systems and applicable regulations.
• Collaborate with clinical teams to assess audit needs and provide GxP guidance.
• Participate in inspection readiness activities and support regulatory inspections.
• Manage and coordinate Audit Consultants as needed.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.