- Develop and implement QA compliance programs as assigned
- Conduct investigator site, service provider and internal audits as needed
- Develop, review, and revise SOPs for GCP/GLP/GVP QA processes
- Promote compliance within the company and represent QA
- Build, develop, and maintain good working relationships with internal and external partners
- Matrix manage projects, including cross-functional teams
- Provide compliance advice as requested or needed
- Help lead in inspections, in agreement with QA management
- Participate in company preparations for regulatory inspections
- Review and identify improvements that enhance the quality assurance system
- Assist Quality management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement
- Establish and maintain quality metrics and reporting
- Coordinate, develop, maintain and/or provide training as requested
- Keep up with GCP/GLP/GPV requirements and developments
- Requires a bachelors degree (BS/BA/ BScN or higher); masters-level degree is preferred, with a minimum of three (3) years managerial Biotechnology/pharmaceutical experience and a minimum of eight (8) years biotechnology/pharmaceutical industry experience
- Advanced knowledge of the pharmaceutical drug development process and current knowledge of FDA regulations for clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is a plus
- Solid well-grounded experience in GXP compliance including knowledge and experience in preparation of Clinical sections of INDs, CTAs, BLAs, MAAs and NDSs submissions
- Proficient in use of electronic clinical database software and other programs such as Microsoft Office
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Director of Quality Assurance - Boston, United States - Albion Rye Associates
2 weeks ago
Description
Director, Clinical Quality Assurance
Location: Boston, Massachusetts
Albion Rye Associates are partnered with one of the fastest growing US Biotech's with a rich Clinical pipeline across various indications to recruit a Director / Snr Director, Clinical Quality Assurance.
Leading a small team, you will be part of the Quality Assurance management function, acting as the Lead GCP Auditor, reviewer and mentor for the team .
This is an excellent opportunity to develop skills within a fast-paced Biotech, with a rich pipeline of studies across Phase I - III.
Responsibilities (including, but not limited to):
Qualifications:
Please email Megan Siggins for more information.
Albion Rye Associates are one of the worlds leading staffing agencies supporting professionals within; Biotech, Pharmaceuticals, Medical Device, Medical & Healthcare Communications, Public Relations, Healthcare Advertising, Market Access, Health Economics and Market Research.
