Responsibilities Include:

•Participate in the development of strategic compliance deliverables to support applicable regulations and internal policies and to ensure systems to be developed adhere to corporate SDLC methodology.

•Organize and facilitate maintenance of documentation (e.g., Standard Operating Procedures, Work Instructions) to ensure complete, accurate, and up-to-date depiction of processes.

•Drive understanding and adoption of Quality and Compliance standards.

•Ensure Quality & Compliance requirements are considered in any initiative or major change request.

•Ensure the compliance deliverables are updated and kept current with all applicable changes.

•Align the development methodology with Compliance plans, policies and procedures.

•Effectively manage ongoing change control process (interface to IT support, impact analysis, release mgt, data changes, testing etc.).


•Bachelors Degree

•4-7 years experience with SOP writing, work instructions and test plans

•Strong documentation experience.

•Experience with 21 CFR-11Submit Resume