Director - Regulatory Affairs/Quality Assurance Biologics Mfg.
June 25, 2018
Full Time - Experienced
The Director will be responsible for the continuous monitoring and interpretation of regulatory requirements, identification of regulatory and compliance risks, and working with leadership to identify actions necessary to reduce or eliminate identified risks. Additional responsibilities may include:
Direction and oversight of regulatory on-site inspections of manufacturing facilities, the development of regulatory review of pertinent documents, maintenance of registrations, and communications with regulatory agencies
Provide content expertise in regulations and guidance to staff regarding regulatory and compliance initiatives
Plan, coordinate, and direct regulatory strategies for new products
Ensure all manufacturing facilities are inspection ready at all times
Develop and implement quality systems management strategies and plans to include resources, timelines, and financials that support, contribute to and integrate with the annual and long-term business strategies.
Attend and represent Mayo Clinic at national conferences.
Serve as a key member of the leadership team with a primary focus on administrative leadership, management of allied health staff, operational and strategic planning, and implementation of policies and systems
Serves as Secretary for the Manufacturing Compliance Subcommittee
A master’s degree in business, healthcare, regulatory affairs, regulatory science, human biology, chemistry or management and 5 years’ experience in a FDA regulated product manufacturing regulatory or compliance role including 5 years of management experience is preferred or a bachelor’s degree, 10 years’ experience supporting FDA regulated product manufacturing including a minimum of 5 years quality, regulatory, or compliance experience, and 5 years of management experience. 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. Additional experience with other international regulations is highly desirable. 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, make critical decisions 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. 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 of responsibilities, work assignments, and priorities. Must also be flexible with work schedule as needed to meet customer needs. Must be self-motivated and able to independently schedule workday activities with minimal direction.
Internal Number: 99318BR
About Mayo Clinic
Join the authority in medicine. At Mayo Clinic, we believe there is a better path to healing that humanizes the practice of health care and inspires hope in the people who need it most. You will be part of an amazing team committed to solving the most serious and complex medical challenges – one patient at a time.