Job Description:

Scope

 

The Quality Assurance Manager, acting as the QA Representative, will be responsible for overseeing the day-to-day quality operations of the company’s preclinical and clinical development programs.

 

 

Responsibilities

 

• Develop, implement, and maintain a full GxP (GCP, GMP, and GLP) compliant clinical/nonclinical QA program.  Assure that all clinical and nonclinical research activities are conducted in compliance to applicable regulatory and company requirements.

• QA Representative for The Company’s organization in vendor-project interactions, such as project team meetings, relationship management, and vendor evaluation
• Ensures that all quality requirements as per relevant regulations and project scope are implemented at contract vendors and are aligned with in-house documentation
• QA review of all Clinical, CMC, preclinical and related documents such as protocols, protocol amendments, draft final reports, final reports and investor brochures.
• Product disposition
• Oversight of document management system
• Manages the change control system
• Ensures all vendor deviations and investigations have proper resolution and appropriate traceable documentation
• Lead the audit coordination of regulatory submission documents
• Supports vendor assurance with respective functional department leads
• Ensures that established SOP are followed, is effective and makes continuous improvements as necessary
• Support departments in the generation of new SOP
• Manages internal and due diligence audits

 

Education, Knowledge & Skill Requirements

• BS (Chemistry, Biology or other related Life Science)
• 4+ years experience managing quality assurance within the biotech/pharmaceutical industry
• Knowledge and understanding of US and Canada GCP, GMP and GLP regulations
• Ability to execute tasks with minimal instruction and guidance
• Strong communication, interpersonal, problem-solving and negotiating skills
• Extreme attention to detail
• A proven track record demonstrating QA leadership and of being highly productive
• Ability to manage and prioritize multiple projects
• Experience with regulatory submissions

External audit experience is ideal