Product Quality Validation Project Manager

3 weeks ago

Raleigh, United States SRG Full time

SRG, the leader in the Life Sciences human capital industry, is looking for a full-time Product Quality Validation Project Manager for a global pharmaceutical company located in Raleigh, NC. This role is responsible for oversight of tech transfer and validation activities in a sterile environment as a critical part of the global quality organization. This position requires a candidate with extensive experience managing large facility validation projects and tech transfer products.


What you need to have:

  • Pharmaceutical Manufacturing facility cGMP validation experience in all processes and equipment in a sterile environment required.
  • Grade A/Class 100 Cleanroom equipment validation experience required.
  • Experience in the US, EU and/or Asia is required.
  • Direct experience in tech transferring API and drug products from development through PQ/PV and successful hand off to commercial team for launch.
  • Ability to formulate and manage VMPs.
  • Ability to lead the project without direct supervision.
  • Preferred: Risk evaluation and mitigation strategy (REMS) program experience; prior experience managing contract and/or outsourced organizations.

Responsibilities include, but are not limited to:

  • Ensuring that the product conforms to all Critical Quality Attributes (CQAs) and meets all Critical Process Parameters (CPPs) at all stages of the manufacturing process during tech transfer and validation
  • Ensures the drug substance and drug product can be sustainably manufactured through applying Quality by Design (QbD) principles and techniques.
  • Works cross-functionally to ensure that there is an appropriate quality handoff and transition through PQ/PV and the commercial business
  • Oversight of all GMP Compliance and Operational QA (Quality Assurance) aspects of Product
  • Manages any third-party activities (including risks)
  • Create, revise, review, and approve validation protocols impacting the product.
  • Conduct periodic reviews for adequacy of Validation and Tech Transfer policies and procedures to assist the business in the strengthening of the PQS (procedures and working practices) and to meet current and regulatory requirements.

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

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