Manager, Clinical Quality Assurance

Harmony Biosciences Holding, Inc.

Reference #: 1359
Harmony Biosciences is recruiting for a Manager, Clinical 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 toGXP (primarily Good Clinical Practice (GCP) but also including Good Laboratory Practice (GLP)) in accordance with ICH and FDA regulations and guidelines. This position will be responsible for ensuring the highest standards of quality and compliance in all clinical and development operations. This position plays a critical role in maintaining regulatory compliance, overseeing GCP processes, and fostering a culture of quality within the organization. Attention to detail, strong knowledge of GCP, GLP, and regulatory requirements, and ability to build partnerships will be essential in achieving operational excellence and ensuring clinical trials are performed in accordance with study protocols and in compliance with all applicable regulatory requirements.

Responsibilities include but are not limited to:
Ensure compliance with GCP and GLP regulations and guidelines, including oversight of clinical trial activities and documentation.
Collaborate with cross-functional teams to develop, implement, and maintain quality systems and processes to support clinical operations.
Conduct audits and inspections of internal processes, vendors, clinical trial sites, and external partners to assess compliance and identify areas for improvement.
Provide guidance and support to project teams in interpreting and implementing regulations, standards, and quality procedures.
Drive continuous improvement initiatives to optimize quality systems, streamline processes, and mitigate risks.
Stay abreast of regulatory requirements, industry best practices, and emerging trends in clinical quality assurance.
Foster strong partnerships with internal stakeholders, including Clinical Operations, Regulatory Affairs, and Pharmacovigilance, to ensure effective collaboration and information sharing.
Support Harmony Biosciences, clinical sites, and vendor partners during regulatory inspections.
Perform other duties as assigned.
Requires up to 20 % travel, which may include overnight and international trips.

Qualifications:
Bachelors degree within a scientific discipline or related field required.
4 years experience in the pharmaceutical industry, preferably within clinical quality assurance or clinical operations, with a strong understanding of GCP and GCLP regulations and practices
Experience auditing or monitoring clinical trial sites
Experience with management or audit of Trial Master File (TMF)
Experience with review or audit of clinical study reports (CSR)
Proficiency in Good Clinical Practice (GCP) guidelines and Regulations. Experience supporting regulatory inspections (FDA, MHRA, EMA, etc.) at clinical sites and vendors is a plus.

Physical demands and work environment:
Domestic and global travel is estimated up to 20% of the time.
Valid US Passport or ability to obtain passport required
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 establish d 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

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/CVs submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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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