Quality Assurance Director

3 weeks ago


Waltham, Massachusetts, United States RPM ReSearch Full time

RPM ReSearch is seeking a highly experienced and skilled Quality Assurance Director to lead our Quality Operations Group (QOG). The ideal candidate will have at least 8 years of experience in a quality leadership position within the biological and/or pharmaceutical industry. This role requires a strong knowledge of FDA and EMA regulatory requirements, as well as GMP regulations and international guidelines.

Job Responsibilities:

  • Perform tasks according to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs).
  • Demonstrate knowledge of and instruct department procedures and company policies.
  • Create yearly goals for the group.
  • Supervise and guide internal audits of various departments/processes.
  • Oversee QA Document Control activities, including processing change requests, manufacturing records, and other documents.
  • Write, revise, and review standard operating procedure (SOP)-controlled forms, and related documentation.
  • Responsible for determining the disposition of all finished and in-process products in compliance with all applicable regulations.
  • Addresses observations or recommendations and implements corrective/preventive actions as needed.
  • Oversee supplier quality program and suppliers.
  • Participate in process improvement teams to offer enhanced expertise and facilitate workflow improvements.

The estimated salary for this position is $140,000 - $160,000 per year, depending on experience and qualifications. We offer a competitive benefits package, including health insurance, retirement plan, and paid time off.



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