Senior Audit Project Manager (Fully Remote)

A pharmaceutical company in Massachusetts is currently seeking a new Senior Audit Project Manager for a promising Fully Remote opportunity with their growing staff. In this role, the Senior Audit Project Manager will be responsible for overseeing the execution of processes related to the qualification of GxP suppliers and support the Internal Audit program.

Responsibilities:

The Senior Audit Project Manager will:

• Coordinate and execute audit schedules


• Execute audit program, including internal and supplier audits and ensuring information is entered into the eQMS


• Monitor audit outcomes and audit findings to ensure timely CAPA follow-up, escalating as required


• Participate in the buildout of our annual audit plan to help ensure it is aligned with strategy and objectives using a risk-based approach


• Aide in development and documentation of business processes to support qualification of a variety of GxP service providers


• Support stake holders in developing and implementing corrective and preventative actions


• Ensure contract auditors are appropriately qualified


• Perform other duties, as needed

Qualifications:

• 10+ years of experience in a the Biotech / Pharma industry; 5+ years of Auditing experience


• Bachelor's Degree in a Life Science related discipline


• Computer savvy


• Microsoft Office Suite proficient


• Solid problem solving and time management skills


• Great interpersonal skills


• Excellent communication skills (written and verbal)


• Strong attention to detail


• Highly organized