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Job Description
We are seeking a dedicated Director of Quality to oversee and enhance our clients' Quality Control (QC) and Quality Assurance (QA) programs. This leadership role involves managing the QC and QA teams, participating in the Senior Leadership Team (SLT), and reporting directly to the CEO.
What you should expect:
- Lead, manage, and ensure accountability within the QA/QC teams.
- Ensure compliance with cGMP, HACCP, Health Canada, and FDA regulations, staying up-to-date with industry standards.
- Oversee employee training to meet regulatory and industry standards.
- Act as a liaison with Health Canada and the FDA for compliance and inspections.
- Collaborate with cross-functional teams to uphold high-quality standards for products.
- Oversee operations, lab investigations, deviations, and customer complaints.
- Implement and review process improvements to maintain cGMP compliance.
- Prepare for, execute, and follow up on voluntary, critical customer, and regulatory audits.
- Serve as a member of the Senior Leadership Team.
What you should bring:
- Advanced degree (minimum four-year undergraduate) in Chemistry, Biology, or related sciences.
- 5-10 years of experience in a quality management role within the pharmaceutical, life sciences, or biological sciences industries.
- Strong knowledge of cGMP.
- Excellent communication skills and ability to collaborate across functions.
- Strong analytical, critical thinking, and problem-solving skills.
- Highly organized with a strong focus on task completion.
- Clear verbal and written communication abilities.
- Advanced understanding of statistics and mathematical equations.
Personal Attributes:
- Effective interpersonal skills and ability to collaborate with direct reports, peers, and management.
- Ability to manage timelines, deadlines, and handle stressful situations.
- Positive attitude and patience.
- Strong problem-solving abilities.
- Active listening, coaching, and feedback skills.
- Attention to detail.
Work Environment:
- This role requires work in office, lab, and manufacturing settings.
Please send resumes to terpstra@summitsearchgroup.com