Director, Head of Clinical Quality Assurance
3 weeks ago
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
-
Director, Head of Clinical Quality Assurance
2 weeks ago
Bridgewater, United States CareerBuilder Full timeDirector, Head of Clinical Quality Assurance (GCP, GLP) 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...
-
Director, Head of Clinical Quality Assurance
2 weeks ago
Bridgewater, United States Gan & Lee Pharmaceuticals Ltd Full timeSummaryThis 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. Life Sciences...
-
VIE - Quality Assurance Coordinator
2 weeks ago
Bridgewater, United States EuroAPI Full timeWe are looking for a VIE - Quality Assurance Coordinator for a VIE contract of 18 months in our US site in Bridgewater to support its activity. Before applying, please make sure to check the VIE eligibility criteria for the United States and add your resume in English to your application. Your responsibilities: Customer Request & Complaints: Collect, handle...
-
Quality Assurance Lead III
2 weeks ago
Bridgewater, United States CareerBuilder Full timeDescription We're looking for a Quality Assurance Lead III , working in Pharmaceuticals and Medical Products industry in 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States . Job description: Develop tools and methods for the North American Quality Business Integrator Project Management Expert to integrate into the Commercial organization as a...
-
Vice President Regulatory Affairs Quality Assurance
Found in: Appcast US C2 - 7 days ago
Bridgewater, United States EPM Scientific Full timeResponsibilities:Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company goals and regulatory requirements.Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA.Provide guidance and expertise on regulatory requirements, standards, and best...
-
Vice President Regulatory Affairs Quality Assurance
Found in: Appcast Linkedin GBL C2 - 7 days ago
Bridgewater, United States EPM Scientific Full timeResponsibilities:Lead the development and execution of regulatory strategies for PMA submissions, ensuring alignment with company goals and regulatory requirements.Oversee the preparation, review, and submission of PMA applications to regulatory authorities, including the FDA.Provide guidance and expertise on regulatory requirements, standards, and best...
-
Director of Health
2 days ago
Bridgewater, United States Distinctive Living Full timeMira Vie at Green Knoll is seeking a Director of Health and Wellness (RN) (Full-Time) that will be located in our Senior Living community located in Green Knoll, NJ Here at Distinctive Living, we want our people to realize their full potential. We're passionate about personal and professional growth and will do everything we can to help you flourish. The...
-
Director of Health
2 weeks ago
Bridgewater, United States Distinctive Living Full timeMira Vie at Green Knoll is seeking a Director of Health and Wellness (RN) (Full-Time) that will be located in our Senior Living community located in Bridgewater, NJ Here at Distinctive Living, we want our people to realize their full potential. We're passionate about personal and professional growth and will do everything we can to help you flourish. The...
-
Program Clinician
6 days ago
East Bridgewater, United States Brockton Area Multi-Servi Full timeJob DescriptionJob DescriptionFull TimeGeneral Statement of Duties: Oversee and coordinate clinical planning, program activities, supports and services for students and families.Responsibilities:Work collaboratively with Program Director to oversee the eligibility, intake and assessment process and assign Resource Counselors to each student making the best...
-
Program Clinician
4 days ago
East Bridgewater, United States Brockton Area Multi-Servi Full timeJob DescriptionJob DescriptionFull TimeGeneral Statement of Duties: Oversee and coordinate clinical planning, program activities, supports and services for students and families.Responsibilities:Work collaboratively with Program Director to oversee the eligibility, intake and assessment process and assign Resource Counselors to each student making the best...
-
Quality Assurance Lead | Bridgewater, NJ, USA
2 weeks ago
Bridgewater, United States CareerBuilder Full timeAre you our Next Visionary? We are seeking an innovative and seasoned technology business development leader who is passionate about the future of Artificial Intelligence. Join our rapidly growing company and help to position us for success in this hands-on role. Who is Openstream.ai? Openstream.ai enables enterprises to engage in meaningful and fluid...
-
Quality Assurance Lead | Bridgewater, NJ, USA
58 minutes ago
Bridgewater, United States Openstream Full timeAre you our Next Visionary? We are seeking an innovative and seasoned technology business development leader who is passionate about the future of Artificial Intelligence. Join our rapidly growing company and help to position us for success in this hands-on role. Who is Openstream.ai? Openstream.ai ® enables enterprises to engage in meaningful and fluid...
-
Director of Counseling Services
5 days ago
Bridgewater, United States Bridgewater College Full timeDIRECTOR OF COUNSELING SERVICES Bridgewater College invites applicants for a Director of Counseling Services. Reporting to the Associate Vice President for Student Life, the Director of Counseling Services provides oversight and management for all fu Director, Mental Health, Service, Management, Education, Program, Clinical
-
Associate Director, Medical Affairs
2 days ago
Bridgewater, United States Bausch Health Companies, Inc. Full timeInclude: Provide strategic input for HEOR initiatives in alignment with overall organizational goals. Collaborate on strategies to demonstrate the unmet need in disease/value of products with a focus on outcomes meaningful to patients, payers, clinic Director, Medical, Associate, Health, Research, Manufacturing, Healthcare
-
Quality Control Manager
Found in: Talent US C2 - 2 weeks ago
West Bridgewater, United States JCSI Full timeQUALITY CONTROL MANAGER***Injection Molding/Plastics experience requiredOverviewCheer Pack is a global packaging solutions provider that's not just manufacturing packaging, but innovating, and creating experiences that resonate. We are currently searching for a QC Manager to support the Director of Quality in employing a variety of measures to foster a...
-
Quality Control Manager
2 weeks ago
West Bridgewater, United States JCSI Full timeJob DescriptionJob DescriptionQUALITY CONTROL MANAGER***Injection Molding/Plastics experience requiredOverviewCheer Pack is a global packaging solutions provider that's not just manufacturing packaging, but innovating, and creating experiences that resonate. We are currently searching for a QC Manager to support the Director of Quality in employing a...
-
Director of Public Works
Found in: beBee jobs US - 3 weeks ago
West Bridgewater, Massachusetts, United States Town of West Bridgewater Full timeDue to retirement, the town of West Bridgewater is seeking qualified applicants for the position of the Director of Public Works. The DPW Director has been with the town for 32 years, the last eight years as the DPW Director.The DPW Director manages and oversees the planning, design, construction, and maintenance of the town's public infrastructure,...
-
Activities Director
3 days ago
Bridgewater, United States Sunrise Senior Living Full timeOverview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."- Sunrise Leader At Sunrise, our Activities & Volunteer Coordinator is responsible for leading the day to day...
-
Summer Day Camp Counselor
2 weeks ago
Bridgewater, United States KE Camps Full timeJob DescriptionJob DescriptionKE Camps is the leading provider of summer camps for country clubs nationwide. We partner with over 230 private clubs all over the country to implement traditional-style day camps for elementary-aged children. Our Staff are the backbone of our programs and therefore, we pride ourselves on giving them an incredible amount of...
-
Summer Day Camp Counselor
4 days ago
Bridgewater, United States KE Camps Full timeJob DescriptionJob DescriptionKE Camps is the leading provider of summer camps for country clubs nationwide. We partner with over 230 private clubs all over the country to implement traditional-style day camps for elementary-aged children. Our Staff are the backbone of our programs and therefore, we pride ourselves on giving them an incredible amount of...