Job details
Job type full-time
Full job description
:
The clinical quality assurance manager (clinical qa manager) will provide consultation in the interpretation of good clinical practice (gcp) regulations, guidelines, policies, and proceduresThe clinical qa manager will plan, conduct, and report on independent audits of internal systems/ procedures and vendorsThe qa manager supports, maintains, and reviews qa systems, corporate training programs, and corrective action and preventative actions (capas).
Essential duties:
Prepare, coordinate, and/or host client and/or regulatory audits
Manage annual internal and vendor audit programs
Conduct qa audits (internal systems and vendor)
Collaborate in sop writing and/or review
Write, review, and track capas
Review & approve audit plans to ensure they are adequate and reflective of the needs identified from risk assessment strategies
Support and/or provide management with quality metrics and updates
Assess internal and external quality information inputs to quickly adjust qa activities or initiatives
Identify and coordinate training within the qa department
Advise, as needed, on quality assurance and compliance topics
Lead and/or participate in identified qa initiatives and projects
Other qualifications:
Strong knowledge of fda, gcp, and ich regulations, guidelines, and standards governing regulated clinical research required
Working knowledge and understanding of drug development and global clinical regulatory environment
Insightful, decisive, proactive, and solutions-oriented
Proven excellence in professional skills including communication, organization, prioritization, discretion, and accuracy
Exceptional customer service skills, including cultivating and maintaining close working relationships with both internal and external stakeholders
Proficiency in ms office including word, excel, powerpoint, outlook, sharepoint, onenote, and virtual meeting software
Flexibility with shifting priorities
Available to travel as needed
Education and/or experience:
Bachelor’s degree in scientific or related discipline, or equivalent work experience
Minimum of 5-7 years industry experience, with at least 3-5 years in clinical qa
Direct experience with internal/external clinical systems and process audits
Experience in qa audits of clinical investigators and clinical vendors
Experience in development of sops
Strong software and computer skills; including ms word, excel, powerpoint, and outlook
Excellent presentation skills
Perks and benefits:
Competitive pay
Career growth
Full medical, dental, and vision benefit packages
401(k)
Commuter benefits
Legal benefits
The best coworkers, if we do say so ourselves
