Direct message the job poster from Evergreen Theragnostics
Vice President Human Resources | Senior Human Resources Professional
Clinical Quality Assurance (QA) Manager and Auditor
Evergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own radiopharmaceutical products and providing contract development and manufacturing services for other radiopharmaceutical companies. We also operate our own cutting-edge cancer research laboratories. The company expects rapid growth in the next few years.
Evergreen is a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.
Position Summary:
The Senior Clinical QA Manager and Auditor will lead and execute quality assurance activities to ensure compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and applicable regulatory requirements across all clinical trial stages. This role involves overseeing quality systems, conducting audits, implementing risk mitigation strategies, and supporting continuous improvement to uphold clinical and manufacturing quality standards. The individual will be responsible for managing internal and external audits, ensuring compliance within clinical and manufacturing processes, collaborating with stakeholders, and providing strategic guidance for the Clinical QA function.
Key Responsibilities:
1. Develop, implement, and manage Clinical QA processes and policies in line with GCP, GMP, ICH guidelines, and regulatory requirements.
2. Oversee quality systems, SOPs, and training programs to ensure compliance across clinical trial operations and manufacturing activities.
3. Act as the primary QA contact for clinical and clinical sites manufacturing quality issues (only applicable to diagnostics studies where manufacturing of the radiopharmaceuticals is done at site), providing guidance on compliance matters and quality control requirements.
4. Plan and/or oversee, conduct, and manage internal and external audits, including investigator site audits, vendor audits, TMF audits, system audits, and GMP-related manufacturing site audits.
5. Ensure audits are performed in accordance with audit plans, timelines, and QA standards for both GCP and GMP areas.
6. Prepare audit reports, document findings, and communicate results to relevant stakeholders, focusing on quality, manufacturing practices, and regulatory adherence.
7. Track and manage corrective and preventive actions (CAPAs) through to resolution, ensuring effective implementation.
8. Identify quality risks in both clinical and manufacturing operations, developing risk mitigation strategies as necessary.
9. Work with clinical and manufacturing teams to proactively manage potential compliance risks and implement preventive actions to mitigate impact.
10. Lead inspection readiness activities for clinical and manufacturing facilities, preparing for regulatory inspections (e.g., FDA, EMA) covering both GCP and GMP standards.
11. Support regulatory inspections by preparing documentation, conducting mock inspections, and coordinating responses to regulatory authorities for both clinical trials and GMP requirements.
12. Develop and deliver training on GCP, GMP, QA processes, and regulatory compliance to clinical and manufacturing teams, investigators, and external partners.
13. Monitor evolving regulatory requirements and industry standards for both GCP and GMP, ensuring QA policies and practices remain up-to-date.
14. Maintain detailed and accurate documentation of QA activities, audit findings, CAPA plans, and compliance metrics for both GCP and GMP areas.
Qualifications:
Education: Bachelor’s degree in a scientific, clinical, or health-related field; an advanced degree (e.g., MS, PhD) is preferred.
Experience: Minimum of 8 years of clinical QA and GMP experience within the pharmaceutical, biotech, or CRO industry, with a focus on GCP auditing, GMP compliance, and clinical trial quality management.
Certification: GCP or GMP quality certification (e.g., RQAP-GCP, RQAP-GMP) is highly desirable.
Skills:
* Strong understanding of GCP, GMP, ICH guidelines, and relevant regulatory requirements.
* Extensive experience in conducting audits and managing quality systems for both clinical and GMP areas.
* Ability to analyze complex quality issues and implement corrective actions.
* Leadership and interpersonal skills to manage cross-functional teams and interact with regulatory authorities.
* Excellent communication, report-writing, and project management skills.
Analytical Thinking: Ability to assess risk, identify non-compliance, and propose practical solutions.
Leadership: Leads by example, fostering a quality-driven culture within clinical and manufacturing teams.
Attention to Detail: Ensures high-quality documentation and thorough auditing practices.
Adaptability: Responsive to evolving regulatory requirements, capable of implementing continuous improvements across GCP and GMP standards.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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