Senior Compliance Auditor

4 weeks ago

Cambridge, United States Vericel Full time

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 Assurance 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:

* 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.
* Write and/or revise Standard Operating Procedures.

Leadership Responsibilities:

* Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics
* 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.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Basic Qualifications:

* 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.

Preferred Qualifications:

* 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.

WORKING CONDITIONS AND PHYSICAL DEMANDS

* Domestic and international travel estimated at 30%

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