We have other current jobs related to this field that you can find below

  • Sr. Director, Quality Assurance Operations

    4 weeks ago

    Bridgewater, United States GQR Full time

    Title: Sr. Director, Quality Assurance OperationsLocation: Bridgewater, NJHybrid role: onsite 2-3 days per week, must live near the site or willing to relocate.Status: Full-time direct hireCompensation: $250,000 to $280,000 Ideal candidates will have experience in small molecules, biologics, and combination/ medical devices.Reporting to the Executive...

  • Sr. Director, Quality Assurance Operations

    4 weeks ago

    Bridgewater, United States GQR Full time

    Title: Sr. Director, Quality Assurance OperationsLocation: Bridgewater, NJHybrid role: onsite 2-3 days per week, must live near the site or willing to relocate.Status: Full-time direct hireCompensation: $250,000 to $280,000 Ideal candidates will have experience in small molecules, biologics, and combination/ medical devices.Reporting to the Executive...

  • Associate Director, Clinical Quality Assurance

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

  • Director, Head of Clinical Quality Assurance

    3 months ago

    Bridgewater, United States Gan & Lee Pharmaceuticals Full time

    Job DescriptionJob DescriptionSummaryThis position reports to the CEO, Gan & Lee Pharmaceuticals. Regular specific interaction also occurs with the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.Education and CredentialsCollege degree in a relevant field....

  • Sr Director, Quality Assurance Operations

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

  • Quality Assurance Director

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

  • Quality Assurance Lead

    7 days ago

    Bridgewater, Massachusetts, United States Ready Pac Produce, Inc Full time

    Quality Assurance LeadDepartment: Quality AssuranceLocation: Not SpecifiedShift: Not SpecifiedCertification in HACCP is required.The Quality Assurance Lead role at Ready Pac Produce, Inc. presents a remarkable opportunity to oversee a team focused on maintaining product excellence and safety. Ready Pac Produce, Inc. is a prominent entity in the fresh food...

  • Quality Assurance/ HACCP LEAD

    3 weeks ago

    Bridgewater, United States Perdue Farms Full time

    Perdue Foods is part of Perdue Farms, a family-owned company heading into it's second century of growth and innovation. With a goal of becoming the most trusted name in premium proteins, we create products for consumers and for retail and foodservice customers around the globe, while changing the way animals are raised for food.SummaryTraining HACCP...

  • Quality Assurance Inspector

    6 days ago

    Bridgewater, Massachusetts, United States Aerotek Full time

    Job Title: Quality Assurance InspectorJob OverviewAs a Quality Assurance Inspector, you will be responsible for conducting thorough inspections to determine the acceptability of incoming materials intended for packaging operations. Your role will also encompass the evaluation and testing of products during various stages of production, ensuring that only...

  • Aviation Quality Assurance Specialist

    6 days ago

    Bridgewater, Virginia, United States Leidos Full time

    Position Overview Are you prepared to take on a pivotal role in aviation quality assurance? At Leidos, we are committed to delivering exceptional solutions through the dedication of our diverse workforce, all focused on achieving our clients' goals. We value our teams, support our communities, and prioritize sustainable practices. Our Mission, Vision, and...

  • Aviation Quality Assurance Specialist

    6 days ago

    Bridgewater, Virginia, United States Leidos Holding Full time

    Make a significant impact in aviation quality assurance At Leidos, we provide cutting-edge solutions through the dedication of our diverse and skilled workforce committed to our clients' success. We empower our teams, engage with our communities, and prioritize sustainability. Our operations are grounded in a commitment to integrity for our clients, our...

  • Director of Operations

    3 weeks ago

    Bridgewater, United States Perdue Farms Full time

    Perdue Foods is part of Perdue Farms, a family-owned company heading into its second century of growth and innovation. With a goal of becoming the most trusted name in premium proteins, we create products for consumers and for retail and foodservice customers around the globe, while changing the way animals are raised for food.SummaryWe are actively...

  • Attending Physician

    2 months ago

    Bridgewater Township, United States Medical Director Services PC Full time

    Medical Director Services PC - Attending Physician (MD / DO)Medical Director Services PC is looking to hire an experienced Attending Physician (MD/DO) to service a skilled nursing facility in Bridgewater, NJ. The ideal candidate will have previous skilled nursing experience.Excellent salary will be offered, commensurate with experience.DUTIES:Assuring...

  • Director of Clinical Support

    3 days ago

    Bridgewater, United States Dentele Group Full time

    Job DescriptionJob DescriptionOur team is looking to bring on an experienced, hands-on,& Director of Clinical Support& to help develop and oversee our doctor concierge services and interdisciplinary projects across all departments. This role reports to our Chief Operating Officer and is supported by our President. This vital role helps ensure our clinicians...

  • Director, Clinical Systems and TMF Operations

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

  • Sr. Quality Control Analyst

    2 weeks ago

    Bridgewater, United States Clinical Resource Network (CRN) Full time

    Our client is looking to fill the role of Sr. Quality Control Analyst. This opportunity will be onsite in the Somerset, NJ area.Responsibilities:In-process materials, raw materials, finished product, or stability sample analysisSupporting cell therapy products and associated assaysResponsible for analytical test review and internal audit supportPrepare...

  • Director of Field Medical Excellence

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

  • Director Field Medical Excellence

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

  • Food Safety Quality Assurance Supervisor

    1 month ago

    Bridgewater, United States Perdue Farms Full time

    Perdue Foods is part of Perdue Farms, a family-owned company heading into its second century of growth and innovation. With a goal of becoming the most trusted name in premium proteins, we create products for consumers and for retail and foodservice customers around the globe, while changing the way animals are raised for food.SummaryCome and join our...

  • Director, Clinical Development

    1 month ago

    Bridgewater, United States Insmed Incorporated Full time

    Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...

Director, Head of Clinical Quality Assurance

2 months ago

Bridgewater, United States Gan & Lee Pharmaceuticals Full time
Job DescriptionJob Description

Summary

This position reports to the CEO, Gan & Lee Pharmaceuticals. Regular specific interaction also occurs with the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.

Education and Credentials

  • College degree in a relevant field. Life Sciences Preferred.

Experience

  • At least 10 years in relevant quality auditor roles in which significant exposure to GCP/GLP has occurred.

Skills

  • Demonstrated ability to lead people in a positive manner.
  • Demonstrated ability to manage multiple and diverse projects concurrently.
  • Demonstrated ability to develop positive relationships and collaborations.
  • Strong analytical skills; a strategic thinker, planner, and implementer.
  • Reliable, dependable, and consistent worker.
  • Conscientious and extremely detailed oriented.
  • Strong ability to create practical and efficient processes.
  • Highly effective interpersonal skills, in individual as well as in group settings.
  • Strong communication skills (English), both written and verbal.
  • Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities:

Audits:

  • Prepare individual audit plans and audit/risk mitigation plans for larger projects/programs in support of Gan & Lee Annual Audit Plan.
  • Plan, conduct, report, and follow-up of internal audits, CRO and site audits, in accordance with current SOP(s).
  • Develop and maintain the GCP audit strategy in collaboration with senior QA leadership.
  • Perform vendor and clinical site evaluations, as required.
  • Clearly communicate and report (verbally and in writing) audit outcomes to the rest of organization, and escalate quality issues as required.
  • Support Gan & Lee Inspection Readiness Activities

Quality Systems:

  • Participate in developing, maintaining and improving of the Quality Management System and associated practices.
  • Participate in inspections performed by FDA and international regulatory agencies; also, audits performed by partners in own area of expertise.
  • Proactively identify analyses and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
  • Deliver input (e.g., GCP, Safety) on relevant projects to the manager and to Quality Management Review
  • Handle Deviations, Quality Issues, CAPAs, and changes as required in the clinical studies.
  • Provide support for SOP Review and Development

Training:

  • Provide input for GCP and other relevant training in QA and in the GCP area.

Knowledge/Regulation:

  • Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
  • Review relevant project documentation for compliance with GCP and corporate standards.
  • Provide GCP expertise within the company as well as externally to vendors and service providers as needed.
  • Provide suggestions for continuous quality improvement in GCP.
  • Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant parts of the Gan & Lee Organization

Powered by JazzHR

U9dV0u5HLk