- Accountable for project completions and achievement of compliance goals.
- Perform internal audits to ensure Vericel compliance to applicable regulations such as GMPs, 820 and Vericel requirements.
- Lead and support supplier and service provider audits (onsite and paper questionnaires) to ensure compliance with GMPs, applicable regulatory requirements and Vericel requirements.
- Support the Vericel Supplier Management Program, including the drafting and maintenance of Quality Technical Agreements, where required.
- Address and/or escalate compliance problems and issues to the Supplier Management Team (SMT) for supplier issues and Quality Management for Vericel internal issues.
- Provide support to the SMT through meeting participation and discussions.
- Provide support to medical device suppliers (CMO) project teams for issue resolution or questions.
- Provide and/or revise Standard Operating Procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor's degree or equivalent with 15 years of experience in a quality unit within the pharmaceutical/biotech industry.
- Five years of experience auditing as a qualified auditor of suppliers for compliance with cGMP, QSR and ICH regulations.
- Knowledge of relevant FDA regulations/guidance and ICH Guidelines.
- Ability to plan/execute and report audits independently.
- Experience in cell manufacturing/biologics, medical devices, and/or software quality.
- Exposure to Good Clinical Practice (GCP) and ICH E6.
- Basic knowledge of GMP regulations.
- Experience with electronic Quality Management Systems.
- Expert knowledge of GMP, QSR regulations.
- Proficient in MS Office.
- Strong communication, organization and time management skills.
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Senior Compliance Auditor - Cambridge, United States - Vericel® Corporation
Description
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Quality Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
This position is responsible for leading / participating in and reporting of internal and external audits. Ensures current Quality Technical Agreements with critical suppliers and service providers.
DUTIES AND RESPONSIBILITIES
Essential Functions:
Leadership Responsibilities:
Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Basic Qualifications:
Preferred Qualifications:
WORKING CONDITIONS AND PHYSICAL DEMANDS
Domestic and international travel estimated at 30%
