Current jobs related to Head of Pharmaceutical Quality Assurance - Jersey City, New Jersey - Clinical Dynamix, Inc.

  • Director of Quality Assurance, NJ

    2 weeks ago

    Jersey City, New Jersey, United States Rbw Consulting Full time

    Quality Assurance Director CDMO NJ, on site Recent Achievements: Environmental Excellence: Recognized for sustainability efforts. Industry Recognition: 2024 Pharmaceutical Supply Assurance Supplier of the Year. Expansion: Acquired new facilities to enhance manufacturing capabilities. A leading global pharmaceutical company in New Jersey is seeking an...

  • Quality Assurance Leader

    2 weeks ago

    Jersey City, New Jersey, United States beBee Careers Full time

    Job OverviewWe are seeking a highly motivated Quality Assurance Leader to join our team. As a key member of the organization, you will be responsible for ensuring compliance with regulatory requirements and internal procedures.Responsibilities:Ensure effective stewardship of New Product Introductions (NPI) programs and their successful progression to...

  • Executive Director, Head of Quality Management System and External Advocacy

    4 weeks ago

    Jersey City, New Jersey, United States Organon Full time

    Job DescriptionThe PositionThe Executive Director, Head of Quality Management System (QMS) and External Advocacy reports to the Associate Vice President, Head of Global Quality Compliance.The Head of QMS and External Advocacy role will establish and maintain an integrated, end-to-end Quality Management System for Organon, ensuring work is conducted to the...

  • Quality Assurance Manager

    2 weeks ago

    Jersey City, New Jersey, United States beBee Careers Full time

    Job Description:">We are seeking a Quality Assurance Manager to join our team. In this role, you will play a critical part in ensuring compliance with regulatory requirements and internal procedures.You will be responsible for stewarding New Product Introductions (NPI) programs and their successful progression to commercial production.Your duties will...

  • Executive Director, Head of Healthcare Products Quality Assurance

    2 weeks ago

    Jersey City, New Jersey, United States Organon Full time

    Job Description The Position The Executive Director, Head of Healthcare Products Quality Assurance (HPQA), reports to the Associate Vice President, Quality Systems and Compliance, Global Quality and supports all Quality and Good Practices Compliance activities related to medical device and combination product device component lifecycle management; owning and...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Royal Bank of Canada Full time

    Job SummaryJob DescriptionSenior Quality Assurance Specialist, RBC Capital Markets, LLC, Jersey City, NJ: As a Senior Quality assurance Engineer, own and lead the quality assurance activities, including, test strategy definition, test planning and carrying out quality assurance practices for one or more Scrum teams. Analyze project requirements by working...

  • Quality Assurance Specialist

    3 days ago

    Jersey City, New Jersey, United States beBee Careers Full time

    **About the Role:**This Quality Assurance Specialist position is responsible for ensuring the quality of surveillance activity performed by our Surveillance and Market Intelligence Group. The successful candidate will apply our Quality Assurance Program's framework to conduct quality assurance reviews and identify areas for improvement.Responsibilities:Apply...

  • Pharmaceutical Program Lead

    2 weeks ago

    Jersey City, New Jersey, United States beBee Careers Full time

    About the JobThis is a senior-level position responsible for managing multiple projects simultaneously. The ideal candidate will have a deep understanding of project management principles and be able to apply them effectively in a fast-paced environment.Key Responsibilities:Manage project budgets, schedules, and resources to ensure timely and cost-effective...

  • Senior Quality Assurance Specialist

    1 day ago

    Jersey City, New Jersey, United States Royal Bank of Canada Full time

    Job Summary Job Description Senior Quality Assurance Specialist, RBC Capital Markets, LLC, Jersey City, NJ: As a Senior Quality assurance Engineer, own and lead the quality assurance activities, including, test strategy definition, test planning and carrying out quality assurance practices for one or more Scrum teams. Analyze project requirements by working...

  • Quality Assurance Tester

    6 days ago

    Jersey City, New Jersey, United States beBee Careers Full time

    Job Summary:We are seeking a skilled Quality Assurance Tester to join our team. As a Quality Assurance Tester, you will be responsible for ensuring the quality and reliability of software products through comprehensive testing and quality assurance.Your primary responsibilities will include:Analyzing customer requests and feedbackDeveloping test cases to...

Head of Pharmaceutical Quality Assurance

3 weeks ago

Jersey City, New Jersey, United States Clinical Dynamix, Inc. Full time
About Us

Clinical Dynamix, Inc. is committed to positively impacting the lives of patients by developing innovative therapies. We are seeking a highly experienced and innovative quality leader to join our team as Associate Director-Quality Assurance.


Job Description

This position will provide CMC quality leadership within the organization and across Contract Manufacturing Organizations (CMOs) and Contract research labs (CROs). The Associate Director, Quality Assurance will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical and commercial products follow cGMP framework and guidelines.


Responsibilities
  1. Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.
  2. Participate and provide guidance on any site and vendor-related quality issues identified.

Requirements
  • B.S. Biological Sciences, Chemistry or relevant discipline and a minimum of 10 or more years' related experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience.
  • 5+ years of hands-on experience with Quality Management System including Electronic Document Management System (Veeva preferred), managing documents lifecycles-Draft to Effective/approved, Initial to Final and Periodic Review.
  • Thorough understanding of Regulatory compliance requirements for the US FDA.
  • Auditor training/experience or certification.