Quality Assurance Manager

4 weeks ago


Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

Harmony Biosciences LLC is seeking a highly skilled Quality Assurance Manager to join our team in Plymouth Meeting, PA.

About the Role:

The Quality Assurance Manager will be responsible for supporting and fostering quality assurance requirements and activities related to cGxP (primarily GMP but also including Good Laboratory Practice and Good Distribution Practice) in accordance with ICH and FDA regulations and guidelines.

Key Responsibilities:

  • 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, ensuring 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.

Requirements:

  • 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.

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.

About Harmony Biosciences LLC:

Harmony Biosciences LLC 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.

Equal Opportunity Employer:

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.



  • Plymouth Meeting, Pennsylvania, United States The Denzel Group Full time

    IT Quality Assurance LeaderThe Denzel Group is seeking an experienced IT Quality Assurance Leader to develop and implement a quality assurance strategy, policies, and procedures from the ground up. This is a direct hire role with a great base salary, equity bonus, and excellent benefits package.Key Responsibilities:Develop and implement a quality assurance...


  • Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

    Job SummaryHarmony Biosciences LLC is seeking a highly skilled Quality Assurance Manager to join our team in Plymouth Meeting, PA. As a Quality Assurance Manager, you will be responsible for supporting and fostering quality assurance requirements and activities related to cGxP (primarily GMP but also including Good Laboratory Practice and Good Distribution...


  • Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

    Harmony Biosciences is seeking a Quality Assurance Manager to support and foster quality assurance requirements and activities related to cGxP in accordance with ICH and FDA regulations and guidelines.This role will be responsible for quality and regulatory compliance, ensuring systems, processes, and their outcomes comply with applicable international and...


  • Plymouth Meeting, Pennsylvania, United States Harmony Biosciences LLC Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Harmony Biosciences LLC. In this role, you will be responsible for supporting and fostering quality assurance requirements and activities related to cGxP (primarily GMP but also including Good Laboratory Practice and Good Distribution Practice) in accordance with ICH and...


  • Plymouth Meeting, Pennsylvania, United States The Denzel Group Full time

    The Denzel Group is seeking a seasoned IT Quality Assurance Program Manager to spearhead the development and implementation of a comprehensive quality assurance strategy. This strategic role comes with a competitive salary, equity bonus, and excellent benefits package.Description:Develop and implement a quality assurance strategy, as well as policies and...


  • Plymouth Meeting, Pennsylvania, United States RX2 Solutions Full time

    Job Title: Quality Assurance SpecialistJob Summary:RX2 Solutions is seeking a skilled Quality Assurance Specialist to ensure the integrity and quality of our software through comprehensive testing methodologies.Main Responsibilities:Regularly assess the progress of testing against the initial plan, making necessary adjustments and providing status...


  • Plymouth Meeting, Pennsylvania, United States Apex Systems Full time

    Job Title: Quality TechnicianJob Summary:Apex Systems is seeking a Quality Technician for a contract position in the Food & Beverage industry in the Malvern, PA area.Responsibilities:Assist with inventory management and ensure accurate tracking of stock levelsFile and maintain paperwork related to quality controlOrganize and prepare samples for quality...


  • Plymouth Meeting, Pennsylvania, United States Braeburn Full time

    Job Summary:The Specialist, Quality Operations Manufacturing is responsible for ensuring the quality and compliance of product manufacturing activities at Contract Service Providers (CSPs) involved in current Good Manufacturing Practices (cGMP) for Braeburn's marketed and pipeline products.This individual will perform quality and compliance review of batch...


  • Plymouth Meeting, Pennsylvania, United States Apex Systems Full time

    Job Title: Senior Engineering ManagerThe Senior Engineering Manager is responsible for providing technical leadership for the specification, development, implementation, and assurance of qualified manufacturing equipment in the respective site. This role aligns manufacturing equipment requirements with the site's mission, ensuring efficient and effective...

  • Office Manager

    1 month ago


    Plymouth Meeting, Pennsylvania, United States Archadeck Outdoor Living Full time

    Job Title: Office ManagerWe are Archadeck Outdoor Living, a leading designer and builder of outdoor living spaces. We seek an Office Manager professional with previous administrative support experience.Responsibilities:Provide administrative and customer support activities for the businessEnter and maintain client data in Archadeck's CRM and Project...

  • Portfolio Manager

    4 weeks ago


    Plymouth Meeting, Pennsylvania, United States SitusAMC Full time

    Job SummarySitusAMC is seeking a highly skilled Portfolio Manager to join our team. As a key member of our Asset Management group, you will be responsible for the day-to-day management of a diverse portfolio of loan and debt financings.Key Responsibilities:Manage assigned loans, including communication with Borrowers and Lenders/Investors and Client.Analyze...


  • Plymouth Meeting, Pennsylvania, United States Masonic Village at Lafayette Hill Full time

    Dietary Manager Job DescriptionMasonic Village at Lafayette Hill is seeking a skilled Dietary Manager to oversee the food service operations of our facility. As a key member of our team, you will be responsible for managing and coordinating the activities of the dining rooms, ensuring that our residents receive high-quality service and a safe dining...

  • Care Manager

    1 month ago


    Plymouth Meeting, Pennsylvania, United States ProgenyHealth Full time

    Job Title: Case ManagerProgenyHealth is a leading provider of care management solutions for infants in intensive care nurseries. We partner with health plans and employer groups to deliver high-quality care to neonatal patients and their families.Responsibilities:Develop and implement individualized care plans for each infant and their familyCollaborate with...


  • Plymouth Meeting, Pennsylvania, United States SitusAMC Full time

    Job SummarySitusAMC is seeking a highly skilled Asset Management Analyst to join our team. As a key member of our Asset Management team, you will be responsible for managing, monitoring, and reporting on the performance of a $90B+ portfolio of largely transitional commercial real estate loans.You will work closely with the Situs Asset Management Team and...


  • Plymouth Meeting, Pennsylvania, United States Gecko Hospitality Full time

    Fast Casual Restaurant Manager Job DescriptionWe're seeking a talented Fast Casual Restaurant Manager to lead our team to success and drive financial results. As a Restaurant Manager, you'll ensure 100% compliance with company policies and procedures, make hiring and termination recommendations, and develop team members. Our ideal candidate has 2+ years of...

  • Nurse Manager

    4 weeks ago


    Plymouth Meeting, Pennsylvania, United States AristaCare Full time

    Nurse Manager OpportunityThe primary purpose of this role is to provide direct nursing care to residents and supervise the day-to-day nursing activities performed by nursing assistants. This position requires a strong leader who can ensure the highest degree of quality care is maintained at all times.Responsibilities:Verify the identity of residents before...


  • Plymouth Meeting, Pennsylvania, United States National Comprehensive Cancer Network Inc Full time

    Make a meaningful contribution to the advancement of high-quality and accessible cancer care globally.This role develops and maintains the NCCN Chemotherapy Order Templates (NCCN Templates) and reviews integration of content from the NCCN Templates into electronic health record (EHR) and utilization management systems.This position requires minimal overnight...


  • Plymouth Meeting, Pennsylvania, United States Liberty Personnel Services, Inc Full time

    Job DescriptionLiberty Personnel Services, Inc is seeking a highly skilled Technical Solutions Manager to join their team.Key Responsibilities:Develop and implement targeted technology solutions to enhance efficiency and user satisfaction.Manage the lifecycle of business applications, ensuring alignment with business goals and delivering a seamless user...


  • Plymouth Meeting, Pennsylvania, United States Sunrise Senior Living Full time

    Job Title: LPN Medication Care ManagerSunrise Senior Living is seeking a highly skilled LPN Medication Care Manager to join our team. As a Medication Care Manager, you will be responsible for providing the highest degree of quality care and services by administering medication and treatments in a safe and organized manner.Responsibilities:Administer...

  • Procurement Manager

    4 weeks ago


    Plymouth Meeting, Pennsylvania, United States Ardan Full time

    Job SummaryWe are seeking a highly skilled Procurement Manager to join our team at Ardan. As a key member of our organization, you will be responsible for coordinating real estate purchase closings, communicating effectively with clients and stakeholders, and delivering high-quality results in a fast-paced environment.Key Responsibilities:Coordinate real...