Senior Manager, Quality Assurance

21 hours ago

Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time
Job Title: Senior Manager, Quality Assurance

Harmony Biosciences is seeking a highly skilled Senior Manager, Quality Assurance to join our team in Plymouth Meeting, PA.

About the Role:

This is a critical position that will be responsible for supporting and fostering quality assurance (QA) requirements and activities related to cGxP (primarily GMP but also including Good Clinical 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.
  • 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.
  • Document proof-reading and compilation may be required.
Requirements:
  • 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.
About Harmony Biosciences:

Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs.

For more information on Harmony Biosciences, visit our website.

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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