The Validation Department provides documented evidence that Operational equipment, systems, and processes involved in commercial product manufacturing, perform in a qualified and reproducible manner and comply with regulatory compliance requirements and current industry/Vericel policy and guidance. The deliverables of the Validation Department include approved Validation protocols and Final Reports. The department also functions as the liaison with Metrology/Calibration Vendors and performs all equipment ownership and quality review responsibilities associated with site calibration activities.
This position is responsible for the oversight and management of the deliverables of the Validation and Quality System Departments which includes: supporting validation for computer systems, equipment, utilities, cleaning, sterilization, and processes and equipment requalification. Additionally, this position will have oversight of Change Control, Product Quality Reviews, Management Reviews and Risk Management. This position directs the development, planning, implementation and maintenance of validation methods, processes and operations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Oversees department schedules, ensuring compliance with appropriate regulatory agency requirements, internal company policies and current industry practices.
- Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
- Provide career development and guidance to direct reports. Identify training requirements/needs and job related qualifications.
- 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.
- Develop work plans, assign tasks, and supervise team(s).
- Ensure staff has appropriate knowledge of department processes and procedures.
- Provide input into budget forecasting when appropriate.
- Establish, maintain and report applicable department or organizational metrics which drive accountability.
- Accountable for project completions and achievement of compliance goals relative to deviations, change controls, CAPA and effectiveness reviews.
- Represent department in Project Team meetings.
- Interact with project teams and cross-functional groups.
- Address and/or escalate site compliance problems and issues to senior department management.
- Lead and facilitate meetings/workshops.
- Participate in the integration of new computer systems and processes.
- Responsible for keeping department in audit ready condition at all times.
- Ensure compliance with appropriate internal and regulatory policies and procedures. This includes product documentation, specifications, and all regulatory requirements.
- Responsible for the creation of validation master plans, and integrated commissioning and qualification plans. Reviewing and approving commissioning and validation documents in accordance with current GMPs.
- Determine and develop validation approaches and resolve complex validation issues, working closely with cross functional teams to address deviations as well as recommend and implement corrective and preventative actions.
- Execute major validation projects and ensure adherence to schedule.
- Communicate validation requirements, timelines, and resource needs to senior management.
- Work closely with the project team members, including Manufacturing, Engineering, and Quality to incorporate the appropriate elements of quality, equipment and production into validation strategies.
- Oversee training and development of staff to ensure compliance with site procedures and regulatory expectations.
- Develop department goals.
- Present validation documents and strategies to Senior Management and regulatory agencies when required.
- Set ambitious and achievable targets to drive for results based on organizational objectives.
- Build effective cross functional relationships.
- Interface with peers and colleagues internal and external to identify and implement best practices.
- Complete/support corrective action plans which address deficient areas identified and ensure adherence to compliance regulations.
- Organize staff and workload distribution to meet or exceed productivity performance standards.
- Engineering/science Bachelor’s degree with a minimum of 12 years of experience in the industry (10 years Validation/Quality) or a Master’s degree with a minimum of 10 years of experience in the life sciences regulated industry (8 years Validation/Quality).
- A minimum of 8 years of experience in a supervisory or management role.
- Experience of working in a GMP environment and knowledge of ICH Q8, Q9, Q10 and FDA, ISO and cGMP regulations.
- Application of risk based approach to validation (FMEA, PHA, etc.).
- Knowledge of Validation Lifecycle Approach, such as ASTM E-2500.
- Experience contributing to regulatory documents development.
- Excellent technical writing and presentation skills.
- Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.
- Experience supporting internal and external audits and oversee closure of all gaps identified during the audits.
- Strong facilitation and team building skills.
- Energetic in the pursuit of improved processes and ultimately improved performance.
- Natural leader/influencer, adaptable, flexible as well as a pragmatically minded problem solver.
- Competent technical knowledge of bio-pharmaceutical plants and manufacturing processes.
- Innovative and capable of developing alternative solutions to issues at hand.
- Good communication skills at organization, team, and individual levels.
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.