What are the responsibilities and job description for the Director of Quality Operations position at Jobleads-US?
Job Description:
We are seeking a highly experienced Associate Director, Quality- QC Support to join our team. In this role, you will be responsible for leading the quality assurance function and ensuring compliance with regulatory requirements.
You will have expertise in biological product testing, method development, and validation. Additionally, you will have strong leadership skills, excellent communication abilities, and experience managing cross-functional teams.
Responsibilities:
- Monitor industry practices and regulatory guidance for biological product testing
- Lead gap assessments and mitigation plans
- Review and approve test methods and method validation/transfer reports
- Support sample management and cell bank management
- Liaise with cross-site QAs and Analytical Leads
- Lead the QA review of analytical data
- Manage and train QA specialists
- Review and approve instrument qualification protocols and reports
- Manage cross-functional teams
Qualifications:
- Bachelors Degree and 10 years of experience required
- Masters Degree and 8 years of experience required
- PhD and 5 years of experience required
- Experience with biological method development and verification
- Familiarity with Annex 1 requirements and ICH guidelines
- Excellent interpersonal, verbal, and written communication skills
