Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing QA professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. POSITION SUMMARY The Quality Operations Supervisor leads a team of QA Specialists. The individual is responsible for the oversight as well as participation in the day-to-day Quality Operations activities which includes the disposition of in-process materials and final product packaging and release. The individual must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product. This position is also responsible for the being a quality reviewer for deviations, events and CAPAs. This includes providing metrics and adherence to timelines. The individual will be required to maintain a positive relationship and to effectively communicate with other departments to meet company goals DUTIES Staff Management: 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 aspects of their job performance and career development including training, feedback, rewards and disciplinary action. Develop work plans, assign tasks, and supervise team(s). Ensure staff has appropriate knowledge of department processes and procedures. Reconcile and approve time detail for employees in ADP and conduct regular 1:1s. Hold monthly staff meetings. Department Management: Establish and report applicable department or organizational metrics which drive accountability. Accountable for project completions and achievement of compliance goals. Represent department in project team meetings. Interact with project teams and cross-functional groups. Address and/or escalate site compliance problems and issues. Lead and facilitate meetings/workshops. Additional Responsibilities: Perform, as well as ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs. Ensure operations documentation meets established requirements for cGMPs, internal SOPs, and company policies. Conduct review of testing results in support of release of intermediates and final product. Assist in deviation/nonconformance identification and resolution. Participate and/or help lead root cause analysis to investigate deviations to determine appropriate root cause and CAPAs and may be responsible for CAPA resolution. Initiate, lead, and act as SME for change controls. Able to independently make decisions on intermediate issues and escalating major issues to Senior Management. Perform validation protocol or final report review to ensure validation criteria and results are appropriate and comply with regulations and current industry standards. Interpret complex, explicit documentation to ensure quality standards and compliance are met. Provide training to new employees. Review and approve deviations, in support of product release. Ensure completion of organizational projects and goals. Represent organization on specific projects. Participate in the internal audit program, as necessary. Other duties as assigned. Leadership Responsibilities: See additional details on Verical Careers site