Temporary Manager - QA and Regulatory Affairs

Description

Note: This is a temporary part-time position through March 2027.

The Manager of Quality Assurance and Regulatory Affairs is responsible for oversight of quality assurance and regulatory compliance for FDA-regulated manufacturing activities supported by the Center for Regenerative Medicine. The Manager identifies and reduces regulatory accreditation and compliance risk by continuously monitoring and evaluating facility policies and practices to ensure compliance is built into the operational systems. This role is accountable for the effective implementation of the Quality Management System (QMS) across all platforms within the Center and serves as the subject matter expert on the policies processes and procedures supporting the QMS by developing a broad knowledge of the practice business and technology as it relates to all areas of the Center for Regenerative Medicine. Operational Quality Assurance and Education within the Center staff report directly to the Manager.

Bachelors degree is required preferably in a science related field (e.g. biology laboratory medicine etc.) and a minimum of 10 years relevant experience with increasing responsibilities in a complex research or healthcare environment is required. Knowledge and experience in the application of laws regulations and guidance documents related to FDA regulated industries (biologics pharmaceuticals devices etc.). Previous experience with FDA GMPs EU regulations and/or ISO certification for product manufacturing is required. Exceptional human relations and communication (written verbal and listening) skills are required. Organizational project management skills are essential along with analytical and critical thinking abilities. Must be flexible and capable of adapting to and facilitating change. Should be very detail-oriented and have the ability to work independently and productively with minimal direction and routinely exercise initiative and sound judgment. Must have the ability to lead motivate and influence others. Compliance issues may create difficult situations for the individuals involved; therefore objectivity and professionalism is essential. ASQ certification in quality and/or GMP principles (e.g. quality process analyst quality improvement associate etc.) is strongly encouraged. Must have demonstrated capacity to comprehend complex protocols programs and situations. The ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines and strong coping skills are required. Must be flexible in adapting to a variety ofresponsibilities work assignments and priorities. Must also be flexible with work schedule as needed to meet customer needs. Experience working in a research environment is preferred. Must be self-motivated and able to independently schedule workday activities with minimal direction.

Additional experience preferred:

• Previous Mayo Clinic experience
• Recent and demonstrated experience leading or supporting the release and qualification of GMP-regulated manufacturing facilities including cleanroom environments used for cell and gene therapy or other biotherapeutic product manufacturing
• Knowledge of facility commissioning qualification and Performance Qualification (PQ) activities for manufacturing suites and associated equipment
• A strong understanding of GMP change control processes and the operational requirements necessary to support the manufacture of clinical-grade products reagents and media

Visa sponsorship is not available for this position. Must be U.S. citizen permanent resident refugee or asylee.

Required Experience:

Manager