Mayo Clinic Looking for Manager Quality Assurance Regulatory Affairs at Florida Full Time

Mayo Clinic offers a variety of employee benefits. For additional information please visit Mayo Clinic Benefits . Eligibility may vary.

Position description
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.

Qualifications
Bachelor’s 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. 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, 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.

Additional qualifications
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. Experience working in a research environment is preferred. Must be self-motivated and able to independently schedule workday activities with minimal direction.

Exemption status
Exempt

Compensation Detail
$107,140 – $160,742 / year

Benefits eligible
Yes

Schedule
Full Time

Hours / Pay period
80

Schedule details
Monday-Friday 8am-5pm, weekends or later hours as needed to support operations

Weekend schedule
N/A

International Assignment
No

Site description
Jacksonville is the largest city in area in the continental United States. A beautiful coastal Florida city that features excellent year-round climate, over 20 miles of beaches and outstanding outdoor recreational, cultural and family-oriented amenities. The “River City by the Sea” has an excellent school system, reasonable cost of living and a thriving business environment. Medical professionals and patients are drawn to Jacksonville by an extraordinary network of high-profile healthcare facilities. Jacksonville continues to grow as more people relocate from all over the U.S. and abroad, to see what the great River City has to offer!

Recruiter
Chelsea Crosby

EOE
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.