Reference #: 1322Harmony Biosciences is recruiting for a Senior Manager, Quality Assurance in our Plymouth Meeting, PA location. In this role you will be responsible for the implementation, and management of the Quality Systems and ensuring overall GMP and GCP compliance. 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 all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high quality products that meet all customer and regulatory agency requirements and expectations.Responsibilities include but are not limited to:Ensure that products and processes meet company and regulatory requirements.Maintain a risk-based quality system to support cGXP activities. Performing document control activities for all GxP related files, including Vendor files, and communications with Regulatory Bodies.Author Quality Standard Operating Procedures / Forms/ Checklists.Provide technical assistance and direction to the other functional groups. Interface with regulatory agencies during routine audits, field complaint investigations, and technical interchanges to present the company's viewpoint.Managing change control, deviation, investigation, CAPA, self-inspection and batch documentation for any GMP/ GCP related activity concerning the manufacture or transit of product, system or process and assessing risk in a manner appropriate for the phase of the product programs.Collaborate on a process, projects, investigations, and process improvementsPrepares and processes key documentation for Quality review.Partner and provide support with colleagues in Medical, Regulatory, and Research departments to provide guidance on applicable regulations.Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.Ensure the efficient use of resources in order to achieve department objectives.Qualifications:Bachelor of Science required; MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology7+ years' experience in pharmaceutical operationsStrong understanding of the functional areas of manufacturing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment.Must have a demonstrable record of developing, implementing and maintaining quality systems.Excellent interpersonal, writing and communication skills and ability to work with cross-functional teams.Ability to work independently, as well as collaborativelyAbility to organize and prioritize work to meet targeted timelines.Proficient in the use of Microsoft Office SuitePhysical demands and work environment:Domestic travel is estimated to be 30% for this role.While performing the duties of this job, the noise level in the work environment is usually quiet.Specific vision abilities required by this job include: Close vision.Manual dexterity is required to use computers, tablets, and cell phone.The employee must occasionally lift and /or move more than 20 pounds.Continuous sitting for prolonged periods.What can Harmony offer you?Medical, Vision and Dental benefits the first of the month following start dateGenerous paid time off and Company designated HolidaysCompany paid Disability benefits and Life Insurance coverage401(k) Retirement Savings PlanPaid Parental leaveEmployee Stock Purchase Plan (ESPP)Company sponsored wellness programsProfessional development initiatives and c ntinuous learning opportunitiesA certified Great Place to Work for five consecutive years based on our positive, values-based company culture

　　Want to see our latest job opportunities? Follow us on !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

　　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.

　　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.