Job Description
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
We are currently seeking a highly skilled Change Control Lead with experience in optimizing change control processes for a project with one of our clients. Project is estimated to be 3 months in length. This role must be performed onsite. Our client is based in the greater Columbus, Ohio area. Local candidates preferred.
Title: Change Control Lead
Position Summary
The Change Control Lead is responsible for managing and optimizing the change control process within a Contract Development and Manufacturing Organization (CDMO) . This role ensures that all changes to GMP manufacturing processes, facilities, equipment, testing and documentation comply with FDA, EMA, and ICH guidelines, as well as advanced therapy medicinal product (ATMP) requirements. The position focuses on maintaining compliance while driving efficiency and supporting business objectives in a fast-paced, highly regulated environment.
Key Responsibilities
Qualifications
Preferred Qualifications
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
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