Senior Manager, Quality Assurance Lead

2 weeks ago

College Station, Texas, United States Matica Biotechnology, Inc. Full time
Job Description

Matica Biotechnology, Inc. is a leading biopharmaceutical research and development company. Our team of experts brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products.

The true value of a Contract Development and Manufacturing Organization (CDMO) is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We're a cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety, and speed of the cell and gene therapy development pathway.

Position Opportunity:

The Senior Manager, Quality Assurance is responsible for day-to-day management of the Quality Assurance team and is responsible for hiring, managing performance, and development of reporting staff. This role is recognized as a subject matter expert with regard to Quality Assurance practices and procedures and serves as the main point-of-contact for all QA activities.

Key Responsibilities:

  • Provide strategic leadership and management for the Quality Assurance organization.
  • Implement continuous improvement initiatives to drive Quality Assurance programs and ensure maximum productivity.
  • Develop, implement, and monitor Quality programs, policies, and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
  • Establish and maintain a positive working relationship with customers, the FDA, and other regulatory authorities.
  • Responsible for all activities related to the Quality Assurance group, including QA on the floor, Quality Operations, and Quality Systems.

Requirements:

  • BS/BA in sciences, preferably in chemistry, biochemistry, microbiology, biotechnology, pharmaceutical sciences, or related technical field.
  • 10+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment.
  • CQA is preferred.

We Value:

  • Start with Safety & Quality
  • Choose the Path of Openness, Honesty, and Integrity
  • Nurture Our Differences to Enable Our Collective Success
  • Learn Continuously to Ensure Our Value and Relevance
  • Commit to Delivering Life-Altering Therapies

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