Quality Assurance Manager
About The Position
The Quality Assurance Manager directly supervises all Quality Assurance and Document Control personnel and is responsible for maintaining the quality system and ensuring compliance with regulatory requirements. The role reports to the Vice President of Global Quality Assurance and oversees Document Control and Quality Assurance Supervisors, Officers, and Assistants. The position is based at the TechLab site, which maintains a climate-controlled environment. Typical work hours are Monday through Friday, either 8:00 a.m. to 4:30 p.m. or 8:30 a.m. to 5:00 p.m. Overtime is occasionally necessary, with or without advance notice.
Requirements
- Bachelor of Arts or Bachelor of Science in life sciences.
- At least 10 years of experience, including 3 years of supervisory experience in a GMP/QSR environment.
- Strong track record of developing and implementing QMS frameworks in regulated industries.
- Excellent leadership, communication, and collaboration skills, with the ability to influence across functional boundaries.
- Experience managing and motivating resources to achieve company and team goals.
- In-depth knowledge of Quality Management Systems and relevant industry regulations.
- Background in continuous improvement, with demonstrated results in cross-functional collaboration.
- Ability to analyze complex quality issues, identify root causes, and implement effective corrective actions.
- Proven ability to handle and resolve quality-related challenges in a dynamic research and manufacturing environment.
Responsibilities
- Ensure the Quality Management System complies with global regulatory requirements.
- Locally implement global compliance and process-improvement initiatives.
- Manage the local Quality Assurance team.
- Perform Quality Management Representative duties within the local Quality Management System and report its status to management.
- Oversee the release of raw materials, components, and finished-product lots.
- Ensure non-conformities and corrective and preventive actions are identified, investigated, and controlled.
- Ensure company training requirements and competencies are documented and current.
- Oversee the Document Control Program.
- Oversee the Validation Program.
- Oversee the Stability Program.
- Oversee Supplier Management.
- Provide information and documentation to support the Annual Management Review.
- Host internal and external audits.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
