Compliance Manager

3 weeks ago


Burlington, Massachusetts, United States Vericel Corporation Full time
About the Position
Vericel Corporation is a leader in advanced therapies for the sports medicine and severe burn care markets. We are seeking an experienced Compliance Manager to join our team. This role will be responsible for overseeing quality compliance activities associated with day-to-day operations, including CMO relationships. The ideal candidate will have strong leadership and personnel development experience, as well as a deep understanding of Medical Device Regulations.

About the Role
The Compliance Manager will work closely with manufacturing and supply chain teams to ensure compliance and business targets are met. They will also be responsible for setting ambitious and achievable targets to drive results based on organizational objectives. In addition, the successful candidate will provide guidance and ensure commercial manufacturing operations (CMOs) are performed in compliance with cGMP.

Key Responsibilities
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance
- Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills
- Establish and report applicable department or organizational metrics which drive accountability
- Represent department in project team meetings

Requirements
- Bachelor's Degree plus minimum of 8 years of industry relevant experience. Prior Quality leadership experience required or master's degree plus a minimum of 6 years of industry relevant experience.
- At least 5 years' experience in managing staff
- Strong understanding of Medical Device Regulations
- Familiarity with cGMP systems (e.g. TrackWise, eBR, eDMS, etc.)

Estimated Salary: $120,000 - $140,000 per year, depending on experience.

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