This role will be split between our new, state of the art facility located in Burlington, MA and our current location in Cambridge, MA.
POSITION SUMMARY
The Quality Operations (QAOps) Manager oversees the quality compliance activities associated with the day-to-day Quality Operations which includes CMO relationships. The individual will work cross functionally to support site projects as well as clinical and commercial products. This role will be focused on Vericel's Medical Device products.
DUTIES AND RESPONSIBILITIES
Quality Ops Responsibilities:
Provide guidance and ensure commercial manufacturing operations (CMOs) are performed in compliance with cGMP.
Partner with manufacturing and supply chain to ensure compliance and business targets are met.
Ensure the batch disposition process is robust.
Support process improvements and streamlining in collaboration with department team.
Drive culture of compliance and openness.
Set ambitious and achievable targets to drive for results based on organizational objectives.
Staff Management:
Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
Department Management:
Establish and report applicable department or organizational metrics which drive accountability.
Accountable for project completions and achievement of departmental goals.
Represent department in project team meetings.
Address and/or escalate site compliance problems and issues.
Lead and facilitate meetings/workshops.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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.).
Strong leadership and personnel development experience.
Preferred Qualifications:
Strong facilitation and team building skills.
Energetic in the pursuit of improved processes and ultimately improved performance.
Innovative and capable of developing alternative solutions to issues at hand.
Good communication skills at organization, team, and individual levels.
A strong understanding of FDA requirements and previous FDA audit experience.
WORKING CONDITIONS AND PHYSICAL DEMANDS
Ability to lift and transport up to 30 lbs.
Must be able to support weekend coverage when required.
Must be able to support rotating holiday coverage.
Ability to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
Must be able to support both manufacturing facilities (in Cambridge and Burlington).
EEO Statement
All 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/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.