Our client is a mid-sized, public, therapeutics company in Cambridge and they are growing! They are seeking an experienced Quality Compliance Manager to manage both internal and external audits, including follow-up on responses and actions related to findings/observations. Reporting to the Sr Director Quality Systems, this is a urgent and critical hire as the company commercializes their 2nd product!
The main function of this role is to manage the development and improvement of the Audit and Vendor Qualification/Management programs to ensure compliance with applicable FDA and other regulatory agency requirements.
Responsibilities include but are not limited to;
• Schedule, execute, report and follow-up on internal and external GMP/GDP audits (Qualification, Routine, For-Cause)
• Ensure audit observations are communicated, escalated as required, tracked and remediated
• Assist with inspection readiness efforts
• Collaborate cross-functionally to execute audit schedule, management of audit CAPAs and vendor risk assessments
• Support continuous improvement efforts through the monitoring of audit metrics
• Support GxP regulatory inspections as required
• Assist with the development, maintenance and execution of the annual audit plan and assess business changes that may impact the audit plan
• Support vendor risk assessment activities, vendor qualification and vendor management efforts including completing vendor audits
• Provide Auditor Qualification training as needed
• Domestic and international overnight travel will be required (20-30%)
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a Bachelor’s Degree in a relevant discipline and 8+ years of quality experience in the pharmaceuticals industry, preferably with commercial GMP focused programs. Must have demonstrated experience and expert knowledge of GMP, GDP and GCP regulations as well as knowledge of FDA, EU, and global requirements and guidelines related to cGMP operations. Must also have experience in hosting regulatory inspections in support of clinical trials and/or commercial operations. As this is a Sr. Manager position, qualified candidates will have 3+ years of experience in a leadership capacity.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.