Director, Head of Clinical Quality Assurance
1 month 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
-
Bridgewater, United States Insmed Incorporated Full timeCompany 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
1 month 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...
-
Director, Head of Clinical Quality Assurance
4 weeks ago
Bridgewater, United States Gan & Lee Pharmaceuticals Ltd Full timeSummary 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....
-
Bridgewater, NJ, United States Insmed Full timeCompany 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 are...
-
Quality Assurance Manager
3 weeks ago
Bridgewater, United States Clinical Dynamix Full timeGlobal Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization. Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good Distribution Practices...
-
Sr Director Quality Assurance Operations
3 weeks ago
Bridgewater, United States Insmed Full timeCompany 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 are...
-
Sr Director Quality Assurance Operations
1 month ago
Bridgewater, United States Insmed Incorporated Full timeCompany 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 Director Quality Assurance Operations
1 month ago
Bridgewater, United States Insmed Incorporated Full timeCompany 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 are...
-
Sr Director Quality Assurance Operations
1 month ago
Bridgewater, United States Insmed Incorporated Full timeCompany 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 Director Quality Assurance Operations
4 weeks ago
Bridgewater, United States Insmed Incorporated Full timeCompany 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 are...
-
Quality Assurance Director
1 week ago
Bridgewater, United States Insmed Incorporated Full timeCompany 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 Director Quality Assurance
1 month ago
Bridgewater, United States Insmed, Inc. Full timeCompany 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 are...
-
Sr Director Quality Assurance
1 month ago
Bridgewater, United States Insmed Incorporated Full timeCompany 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 Director Quality Assurance
1 month ago
Bridgewater, United States BioSpace Full timeJob Details 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...
-
Director, Clinical Operations
3 weeks ago
Bridgewater, Massachusetts, United States Bausch Health Full timeBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global...
-
Quality Assurance Manager
4 weeks ago
Bridgewater, United States Hisun Pharmaceuticals USA Full timeZhejiang Hisun Pharmaceutical Co. Ltd. was established in 1956 and currently employs over 9,000 people and is a public trade company (stock code 600267). Hisun’s vision is to become a widely respected international pharmaceutical company by advancing its mission of persisting in pharmaceutical innovation for the benefit of human beings. Hisun...
-
Sr Director Quality Assurance
3 weeks ago
Bridgewater, New Jersey, United States Insmed Incorporated Full timeCompany 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 are...
-
Quality Assurance Manager
1 week ago
Bridgewater, United States Johnson ReSource Group Full timeGlobal Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization. Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good Distribution Practices (GDP)...
-
Quality Assurance Manager
1 month ago
Bridgewater, United States Gables Search Group Full timeGlobal Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good Distribution Practices (GDP)...
-
Quality Assurance Manager
7 days ago
Bridgewater, United States Gables Search Group Full timeGlobal Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expanding Looking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization. Managing and supporting Good Manufacturing Practices (GMP). Role will support the Good Distribution Practices (GDP)...