I am a passionate advocate for science and a dedicated guide, advisor, and friend. My mission is to create a positive and lasting impact. Let’s journey together towards a future where science not only fuels our passion but also transforms lives.
We are Hiring
Manager,
Clinical Quality Assurance
Manager, Clinical Quality Assurance
Onsite, 3 days a week-Greater Boston
Travel: Up to 20%, primarily within US and Canada
We are seeking a Manager of Clinical Quality Assurance (CQA) to oversee and manage quality system elements, including audit programs, inspection preparation, continuous improvement, and procedural documentation. This role requires interfacing with internal and external stakeholders to ensure compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
Position Responsibilities
- Lead CQA for assigned trials and compliance areas, ensuring timely communication of quality risks and compliance related to GCP/cGLP
- Develop and execute a risk-based clinical quality audit plan for assigned programs
- Audit internal processes, clinical investigator sites, and vendors for regulatory compliance, and evaluate scientific data accuracy and quality
- Analyze and trend audit observations to support continuous improvement in clinical development programs, vendors, and functional groups
- Evaluate the adequacy and completeness of CAPA from audits, deviations, and inspections, and perform effectiveness checks
- Author and manage audit reports and documentation in the QMS
- Peer review reports authored by colleagues
- Identify non-compliance trends and systematic risks.
- Contribute to the development, maintenance, and continuous improvement of quality system processes, tools, and e-systems.
- Facilitate regulatory agency inspections and related activities.
- Support mock inspections and provide inspection preparation training to internal staff, clinical sites, and vendors.
Basic Requirements
- Bachelor’s degree in a scientific discipline
- Minimum of 7 years in the pharmaceutical or biotech industry, with at least 5 years in Clinical Quality Assurance
- Comprehensive understanding of ICH GCP and applicable CFR regulations, with knowledge of cGLP
- Experience with risk-based quality management systems and quality by design in Phase I-IV clinical trials
- Ability to collaborate diplomatically at all organizational levels
- Strong analytical and critical thinking abilities
- Experience developing SOPs and Work Instructions, and reviewing internal processes for accuracy
- Preferred experience in oncology and/or medical imaging clinical development
- Excellent communication, planning, coordination, and time management skills
- Ability to collaborate diplomatically at all organizational levels
Are you ready to make a difference in the field of medical diagnostics and therapeutics? Join our innovative team and help us advance healthcare with groundbreaking products and solutions. If you’re passionate about science, driven by purpose, and eager to contribute to life-changing medical advancements, we want to hear from you!
We work with you to uncover your career goals and talents to find the ideal fit.
Contact Christina Cagle
© 2024 The Elle Group. All Rights Reserved.