Quality Assurance Operations Lead

3 weeks ago


Burlington, Massachusetts, United States Vericel Corporation Full time
Job Overview
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a top performing Quality Assurance professional to join our team. This exciting opportunity offers a chance to contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics.

The selected candidate will oversee quality compliance activities associated with day-to-day operations, including relationships with Contract Manufacturing Organizations (CMOs). This role requires cross-functional collaboration to support site projects, clinical and commercial products, focusing on Vericel's Medical Device products.

We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience, along with a comprehensive benefits package.

Key Responsibilities
- Ensure CMOs perform commercial manufacturing operations in compliance with cGMP.
- Partner with manufacturing and supply chain teams to ensure compliance and business targets are met.
- Develop and maintain robust batch disposition processes.
- Collaborate with department teams to improve processes and drive results.

Staff Management
- Select, develop, and motivate qualified staff to effectively carry out department functions and provide continuity of managerial skills.
- Provide leadership, guidance, and direction to staff consistent with cGMP and corporate quality governance.
- Coach and mentor staff in job performance and career development, including training, feedback, rewards, and disciplinary action.

Required Qualifications
- Bachelor's Degree plus minimum 8 years of industry relevant experience 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 and familiarity with cGMP systems.

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