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Manager, Quality Assurance Systems
4 months ago
Harmony Biosciences is recruiting for a Manager, Quality Assurance Systems 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 Laboratory 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 and assure systems, processes and their outcomes comply 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.
Manage suppliers in a risk based program, including the following:
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.
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.
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
Physical demands and work environment:
Travel is estimated to be 15% of the time, both domestic and international. Valid US passport is required the ability to obtain.
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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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 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.
Recruitment agencies please note:
Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
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