Senior Manager - Contract - Cambridge MA
Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
娇色导航 is seeking a Senior Manager, R&D Quality Assurance to join a dynamic team in Cambridge, MA. In this role, you will play a key part in ensuring compliance with Good Clinical Practice (GCP), regulatory guidelines, and company procedures.
Primary Responsibilities:
The successful candidate will lead quality assurance activities for clinical trials, oversee audit processes, and support inspection readiness efforts. This is a hybrid position, offering a mix of on-site and remote work.
Skills & Requirements:
- Bachelor's degree in life sciences or a related field (Master's preferred).
- Strong experience in GCP Quality Assurance and clinical trials, particularly in late-phase trials.
- Proven ability to lead audits and inspection readiness efforts, with direct inspection experience.
- Comprehensive knowledge of GCP regulations and industry guidance (e.g., FDA, EMA).
- Familiarity with Quality Assurance functions such as auditing, clinical operations, regulatory affairs, and data management.
- Excellent problem-solving, organizational, and communication skills.
The Senior Manager's responsibilities will be:
- Lead the development and execution of study audit plans, including site selection, audit agendas, reports, and corrective/preventive action plans (CAPAs).
- Oversee quality activities for Phase 2/3 trials, focusing on risk management and endpoint de-risking.
- Conduct risk-based reviews of study documents and ensure compliance with protocols, ICH-GCP, and regulatory requirements.
- Manage quality events related to sponsor, clinical site, or vendor non-compliance, including investigations and CAPA development.
- Provide GCP quality guidance across various organizational groups.
- Drive inspection readiness efforts for clinical studies, including preparation for regulatory inspections (e.g., EMA, FDA, PMDA).
- Lead site inspection readiness training visits and manage site-level inspections.
- Support vendor quality oversight, including audit scope input, review of audit responses, and co-auditing as needed.
- Participate in process audits, process improvement initiatives, and updates to QA tools and SOPs.
- Contribute to regulatory intelligence reviews and provide subject matter expertise.
Compensation:
- $90.00 - $100.00 Per Hour
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
娇色导航 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 娇色导航 is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy
