Quality Assurance Manager
Job Opportunity: Quality Assurance & Compliance Lead (Contractor)
Our client is seeking a dynamic Quality Assurance & Compliance Lead to lead their QA&C team to new heights. If you have a strong background in GCP regulations and supervisory leadership, this could be the perfect role for you!
Primary Duties & Responsibilities:
- Team Management: Oversee and develop QA&C personnel.
- Internal Guidance: Advise on regulations and standards.
- Project Leadership: Act as the main QA&C contact for projects/clinical trials.
- Compliance Management: Handle deviation documentation, CAPAs, and GCP compliance.
- Audit Oversight: Manage client and internal/vendor audits.
- Training & Hiring: Coordinate training events and assist with hiring.
- Process Improvement: Track quality data and suggest improvements.
- Documentation: Author and review controlled documents.
Experience & Requirements:
- Bachelor’s degree (science-related preferred).
- 10+ years of GCP experience in an FDA-regulated environment, including 5 years in sponsor/CRO industry and supervisory roles.
- Strong knowledge of GCP regulations, ICH, FDA guidelines, and global clinical research regulations.
- Excellent communication, organizational, and problem-solving skills.
- Proficiency in Microsoft Project, Word, Excel, and PowerPoint.
Must have 5 years in a supervisor or manager position.
Apply by sending your resume in today
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Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Quality Assurance -
Industries
Pharmaceutical Manufacturing
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Medical insurance -
Dental insurance -
Vision insurance
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