Senior Quality Assurance Manager
3 days ago
Amotec is seeking a Sr. Quality Manager to join our client, a global leader in the medical device industry, located in Tempe, AZ. The Sr. Quality Manager will be responsible for leading and executing quality assurance strategies, ensuring compliance with regulatory requirements, and driving continuous improvement across the site’s quality operations.
Sr. Quality Manager Responsibilities:
- Lead the execution of the quality assurance strategy for the Tempe site, ensuring alignment with global quality objectives.
- Collaborate with site leadership to support strategic business planning and execution of site objectives.
- Oversee quality functions for combination medicinal products, medical device components, and packaging to meet regulatory standards.
- Manage interactions with regulatory agencies, ensuring compliance with FDA and other regional requirements.
- Lead and mentor Quality Assurance, Quality Engineering, and Quality Systems teams.
- Monitor quality metrics (KPIs) and provide updates to senior management.
- Ensure site readiness for third-party audits and maintain all necessary compliance documentation.
- Drive customer satisfaction initiatives to ensure product quality meets or exceeds customer expectations.
- Manage the quality department budget and resource allocation.
Sr. Quality Manager Qualifications:
- Bachelor’s Degree in pharmacy, chemistry, biology, or a related field.
- At least 10 years of experience in medical device/pharmaceutical manufacturing, quality assurance, or regulatory affairs.
- Proven experience with FDA regulations and other regulatory agency requirements.
- Strong leadership and cross-functional team collaboration skills.
- Knowledge of cGMP, ICH guidelines, and quality management systems.
If you would like to learn more about this opportunity please contact Nadine Flynn at nflynn@amotecinc.com.
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