Senior Manager, Quality Assurance

3 days ago

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

Harmony Biosciences is seeking a Senior Manager, Quality Assurance to join our team in Plymouth Meeting, PA. In this role, you 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 with colleagues in Manufacturing, Regulatory, Clinical, Medical, and Technical Operations to ensure 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.
  • Assist in processing and reviewing deviations and change controls from contracted manufacturing operations.
  • Document proof-reading and compilation may be required.
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.

Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. We are committed to providing novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com.

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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