Director, Quality Operations
2 weeks ago
POSITION SUMMARY
This position is responsible for the oversight and management of the deliverables of the Quality Assurance, Document Control, and Quality Supplier Management departments which includes disposition of in-process materials and finished product, labeling and documentation, deviations, CAPAs and product complaints. Additionally, manages the system for controlled documentation and the oversight of supplier management and internal audits.
ESSENTIAL FUNCTIONS
Staff Management:
- Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
- Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
- Provide organizational and managerial structure that supports the various levels in the organization.
- Works on complex issues where problems are not clearly defined and where fundamental principles do not fully apply.
- Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
- Ensures schedules meet corporate requirements.
Department Management:
- Interact with project and product managers, as well as peers in other functional areas to ensure successful release of product.
- Align department objectives with site business objectives.
- Establish key performance indicators, maintain, and report applicable department or organizational metrics.
- Participate in cross-functional projects and project team meetings.
- Interact with project teams and research groups as they impact the quality operation.
- Contribute to the evaluation and mitigation of program risks and escalation of potential significant quality issues.
- Perform work under limited direction and guidance, with general instruction on new assignments.
- Develop, interpret and execute organizational policies.
- Provide recommendations for process improvements.
- Work on moderately complex problems related to the manufacturing processes and schedules for new or existing products requiring an in-depth analysis of various factors.
- Other duties as assigned
Additional Responsibilities:
- Manage lot disposition activities to ensure that products are released in accordance with regulatory requirements, cGMPs and policies and procedures and within project lead times.
- Oversees generation and review of documents used in good manufacturing practices.
- Ensure timely development and closure of internal audit responses and CAPAs.
- Ensure site/ program compliance and support for controlled document lifecycle and/ or records management processes.
- Ensure compliance with supplier management program.
- Coordinate interdepartmental activities.
- May lead investigations and resolve potential product quality issues to improve efficiency.
- Contribute to the evaluation and mitigation of program risks and escalation of potential significant quality issues.
- Review and approve documents necessary to support the program and disposition activities originating from internal departments and vendors.
- Participate in developing project plans and/or corrective action that may impact multiple functions.
- Perform work under limited direction and guidance, with general instruction on new assignments.
- Develop, interpret and execute organizational policies.
- Provide recommendations for process improvements.
- Provide guidance and mentorship to managers and supervisors within Quality Assurance, ensuring their teams are functioning at a high capacity.
- Work on moderately complex problems related to the manufacturing processes and schedules for new or existing products requiring an in-depth analysis of various factors.
- Other duties as assigned
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
- Bachelor’s degree with a minimum of 14 years of experience in a biotech or pharmaceutical regulated industry (minimum of 10 years in Quality/8 years directly related to management of personnel). Prior leadership experience required.
- Master’s degree with a minimum of 12 years of experience in the life sciences regulated industry (minimum of 10 years in Quality/8 years directly related to management of quality personnel). Prior leadership experience required.
- Strong working knowledge of ICH, FDA, ISO and cGMP regulations.
- Excellent technical writing and presentation skills.
- Strong leadership and personnel development experience
- Excellent communication skills at organization, team and individual levels.
Preferred Qualifications:
- Prior Medical Device experience required
- Proficient in Auditing, both internal and vendor
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Ability to lift up to 30 lbs.
- Ability to travel up to 20% of time
- Must be able to support holiday coverage when required
- Must be able to gown into the CNC areas when required.
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.
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