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):

• 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

Qualifications:

• Requires a bachelor’s 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

Please email Megan Siggins for more information.

📩megan.siggins@albionryeassociates.com

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.