Why Mayo Clinic
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You'll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.
Responsibilities The incumbent will work closely with the Director of Regulatory Affairs/Quality Assurance for FDA-Regulated Manufacturing, Medical Directors, Site Compliance Officers, Compliance Analysts, and others to ensure compliance with Mayo Clinic Integrity and Compliance Program requirements, US Food and Drug Administration (FDA) regulations for Drugs, Devices, Biologics, and HCT/P's including 21 CFR 210, 211, 212, 600's, 820, 1271, related ISO standards, and Mayo Clinic policies and procedures.
Job Duties and Responsibilities:
• Provide indirect support to internal manufacturing areas including advising, coaching, training, project delegation and oversight, regular statuses, and scheduling
• Oversee investigations and audits of Mayo Clinic FDA-regulated manufacturing areas
• Work directly with Medical Directors and legal representatives to oversee and document complex Compliance investigations
• Respond timely and professionally to questions from Mayo Clinic employees related to quality management systems for operational areas and interpretation of current manufacturing regulations.
• Evaluate and advise new cGMP manufacturing areas
• Consult with business proponents to consider Compliance risks related to organizational initiatives
• Surveillance of new and changed requirements/regulations
• Investigate and document complex Compliance Hotline reports
• Maintain FDA registrations
• Develop and present in-person Compliance training for Mayo Clinic employees
• Conduct on-site audits of various Mayo Clinic departments to assess compliance with Mayo Clinic policies
• Assist with FDA inspections
• Draft policies and oversee implementation of procedures
• Lead multi-disciplinary workgroups and projects
• Investigate and respond to complaints filed with regulatory agencies
• Represent Compliance on institutional committees
• Other functions and projects as assigned
• Some travel may be required to other Mayo Clinic sites and/or training conferences This vacancy is not eligible for sponsorship/ we will not sponsor or transfer visas for this position. Also, Mayo Clinic DOES NOT participate in the F-1 STEM OPT extension program. This position will accept applications until 04/06/2024. This deadline may be extended if the necessary candidate pool is not met by this date.
Qualifications Qualifications: Bachelor's degree required and a minimum of 5 years' experience in compliance, privacy, health information management, internal audit, human resources, legal, investigations, information security, or a related field. Master's or Juris Doctor degree preferred
Additional Qualifications (Preferred): Bachelor's Degree in a STEM field or Master's degree in a scientific or regulatory field preferred. Experience in FDA-regulated manufacturing, quality assurance/quality control, regulatory affairs, pharmaceuticals, biologics, or device preferred.
.• Ability to maintain highest level of confidentiality
• Healthcare technology experience
• Experience supervising exempt staff
• Knowledge of Federal and State regulations related to manufacturing compliance
• Systems knowledge of Oracle and electronic Quality Management Systems
• Effective training and presentation skills
• Complex investigation and audit experience
• Proficient in Excel, Word, and Power Point
• Demonstrated ability to set priorities and to respond to changing demands from multiple sources
• Ability to follow-through, meet regulatory deadlines, anticipate requirements, and build relationships
• Strong analytical and problem-solving skills
• Ability to communicate effectively with diverse groups including attorneys, physicians, patients, allied health staff, researchers, and vendors
• Ability to lead in a team environment with minimal supervision
Exemption Status
Exempt Compensation Detail
$88,774 - $124,300/ year Benefits Eligible
Yes Schedule
Full Time Hours/Pay Period
80 Schedule Details
Monday - Friday normal business hours. Rare, but may be required to work after normal business hours as business needs dictate. This is a remote position, but candidate will be required to be within driving distance of Rochester, MN. Weekend Schedule
Rare, but may be required to work weekends as business needs dictate. International Assignment
No Site Description Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is.
Affirmative Action and Equal Opportunity Employer
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.
Recruiter
Stephanie Brackey
