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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 (https://jobs.mayoclinic.org/benefits/) – 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 Sr. Quality Analyst, FDA Regulated Manufacturing will be part of a team of four, consisting of the site QA manager, one QA specialist and two senior QA specialists.

• Is responsible for oversight of quality and regulatory compliance for product manufacturing activities.

• Works to identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices to ensure compliance is built into the operational systems.

• Oversees manufacturing compliance by making interpretations and developing executive summaries of regulatory and compliance information, maintaining registration information, communication with external regulatory and accreditation agencies.

• Communicates and works effectively with leadership to take necessary actions to mitigate identified risks.

• Is accountable for the effective implementation of the Quality Management System (QMS) and serves as a subject matter expert on the policies, processes and procedures of the QMS by developing a broad knowledge of the practice, business and technology as it relates to product manufacturing.

Qualifications

A master’s degree in product manufacturing medicine, business, regulatory compliance, or management and 5 years’ experience in a quality related field is preferred or a bachelor’s degree, 5 years’ experience supporting FDA regulated product manufacturing, and 5 years quality, regulatory, or compliance experience.

Knowledge and experience in the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, etc.) and 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 skills. 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. Must be experienced in conducting audits. Remains abreast of current, new, and developing industry trends, regulations, and legal positions related to FDA regulated manufacturing, patient care, and information management. Possesses strong human relations skills and problem solving skills in order to influence all levels of the organization toward regulatory and accreditation compliance. Possesses strong written and verbal communication skills. Works independently with minimal direction and is self-motivated.

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. ASQ certification in quality and/or GMP principles (e.g., quality process analyst, quality improvement associate, etc.) is strongly encouraged.

Exemption Status

Exempt

Compensation Detail

$ 81,744.00 - $ 122,678.40 / year; Education, experience and tenure may be considered along with internal equity when job offers are extended.

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

8:30-5:30 (may be flexible, based on business needs)

Weekend Schedule

N/A

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. (https://jobs.mayoclinic.org/alllocations)

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

Chelsea Crosby

Equal opportunity

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.