Harmony Biosciences is recruiting for a Senior Manager, Quality Assurance in our Plymouth Meeting, PA location. In this role you will be responsible for supporting and fostering quality assurance (QA) requirements and activities related tocGxP (primarily GMP but also including Good Clinical Practice and Good Distribution Practice) in accordance with ICH and FDA regulations and guidelines.
This position will also be responsible for quality and regulatory compliance with applicable international and national standards, regulations, and guidelines.
The primary function of the QA department is to build, monitor and sustain a robust and effective quality system that delivers reliable, safe, and effective pharmaceutical products that meet all customer and regulatory agency requirements and expectations.
Responsibilities include but are not limited to :
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.
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
Physical demands and work environment :
- Domestic travel is estimated to be 10% of the time.
- Specific vision abilities required by this job include : Close vision.
- Manual dexterity required to use computers, tablets, and cell phone.
- Continuous sitting for prolonged periods.
What can Harmony offer you?
- 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
- A certified Great Place to Work® for six consecutive years based on our positive, values-based company culture
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