Careers

Department: Quality Systems

Office: Cambridge

Department Description:

The Quality Systems Department manages Change Control, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapies products.

 Staff works closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation is compliant with regulations, procedures and policies.

Position Summary:

The leader of the Quality Systems Department will develop and motivate qualified staff to effectively carry out department functions. They will provide leadership, guidance and direction of staff consistent with cGMP and company corporate quality governance. They will coach and mentor staff in all aspects of their job performance can career development including training, feedback and disciplinary action. They will ensure that the staff has a full understanding of department processes and procedures. Finally, provide input into the department budget when appropriate and responsible for ensuring changes to manufacturing processes are controlled.

Essential Functions:

  • Direct involvement in day to day operations – including FMEA facilitation, Cross Functional Change management Meetings, department streamlining/improvements, site procedure education
  • Facilitate/Lead external regulatory inspections
  • Motivate and inspire a quality compliance culture across the organization
  • Build effective and sustainable cross functional relationships
  • Drive an environment of teamwork and open communication
  • Establish key performance indicators for department
  • Accountable for project completions and achievement of such goals
  •  Building collaborative cross-functional relationships

Required Education and Experience:

  • Bachelor’s degree or equivalent and 8+ years of experience in a biotech, pharmaceutical, or similarly regulated industry
  • 5+ years of leadership experience directly related to Quality Management
  • A strong understanding of regulatory requirements affecting Biologics and Medical Devices
  • Strong leadership and personnel development experience
  •  Proven Risk Management/FMEA experience/knowledge

Preferred Education and Experience:

  • Previous Quality leadership experience in an organization involved with medical device/biologics
  • A strong understanding of Medical Device and Biologics FDA regulations
  •  5+ years of leadership experience directly related to Quality Management

  

 All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.