Quality Assurance Manager

3 weeks ago


Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team at Harmony Biosciences LLC. In this role, you will be responsible for supporting and fostering quality assurance requirements and activities related to cGxP (primarily GMP but also including Good Laboratory Practice and Good Distribution Practice) in accordance with ICH and FDA regulations and guidelines.

Key Responsibilities

  • Partner and provide support with colleagues in Manufacturing, Regulatory, Clinical, Medical and Technical Operations to ensure that products and processes meet company and regulatory requirements.
  • Manage suppliers in a risk-based program, including ensuring that products and processes meet company and regulatory requirements.
  • Review production records to assure no errors have occurred or if errors have occurred that they have been fully investigated.
  • Review procedures or specifications impacting on the identity, strength, quality and purity of Harmony Drug Products.
  • Assist in processing of Product Complaints and Product Investigations.

Requirements

  • Bachelor's degree in a life science discipline or related field required.
  • 4+ years of experience in functional areas of manufacturing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment; with at least 3+ years' experience in pharmaceutical QA operations.
  • Must have a demonstrable record of maintaining quality systems, including but not limited to Change Control, Deviations/Investigations and Document Management.
  • Proficient in the use of Microsoft Office Suite.

What We Offer

  • Medical, Vision and Dental benefits the first of the month following start date.
  • Generous paid time off and Company designated Holidays.
  • Company paid Disability benefits and Life Insurance coverage.
  • 401(k) Retirement Savings Plan.
  • Paid Parental leave.
  • Employee Stock Purchase Plan (ESPP).
  • Company-sponsored wellness programs.
  • Professional development initiatives and continuous learning opportunities.


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