Job Description
Kelly Government Solutions is seeking a talented Manager of Quality Assurance with expertise in CMC and early-stage drug development (pre-IND and early clinical) compliance for a direct hire opportunity. This role will be responsible for overseeing and managing all aspects of Quality Assurance operations, ensuring that all applicable regulations are followed and that the highest quality standards are maintained throughout the drug development process. This includes developing and implementing quality systems, conducting gap analyses and remediation activities, and collaborating effectively with cross-functional teams, including manufacturing, QC, CMC regulatory, and Contract Research Organizations.
The ideal candidate will have a solid understanding of relevant regulatory agency guidance, including ICH and FDA regulations, and will be adept at working both independently and collaboratively. They will also possess strong communication and interpersonal skills, as well as the ability to lead and motivate a team.
Key Responsibilities: - Oversee overall QA operations and ensure regulatory compliance.
- Develop and implement quality systems.
- Conduct gap analyses and remediation.
- Collaborate with manufacturing, QC, CMC regulatory, and CROs.
Qualifications: - Minimum 5 years of QA experience in a pharmaceutical setting.
- Expertise in CMC and early-stage compliance.
- Strong knowledge of ICH and FDA regulations.
- Excellent communication and collaboration skills.
Benefits:
401(k)
401(k) matching
Flexible schedule
Paid time off
Health and Dental plans
If you are a highly motivated and experienced Quality Assurance professional with a passion for ensuring product quality and compliance, we encourage you to apply for this exciting opportunity. Please send your resume to Kristi.boggs@kellyservices.com
9518637
Job Tags
Full time, Contract work, Flexible hours,