Senior Manager, Quality Assurance Specialist

1 week ago


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

We are seeking a highly skilled Senior Manager, Quality Assurance to join our team at Harmony Biosciences LLC. As a key member of our quality assurance department, you will be responsible for ensuring the quality and regulatory compliance of our pharmaceutical products.

Key Responsibilities
  • Partner with colleagues in manufacturing, regulatory, clinical, medical, and technical operations to ensure that products and processes meet company and regulatory requirements.
  • Ensure that products and processes meet company and regulatory requirements.
  • Assist in processing and reviewing deviations and change controls from contracted manufacturing operations.
  • 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.
Qualifications
  • Bachelor's degree in a life science discipline or related field required.
  • 6+ years of experience in a functional area such as: manufacturing, materials management, quality assurance and control, and laboratory operations in a pharmaceutical clinical and commercial manufacturing environment.
  • 3+ years of experience in pharmaceutical QA operations (clinical and commercial) required.
  • Must have a demonstrable record of reviewing 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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