Senior Quality Analyst – FDA Regulated Manufacturing

Mayo Clinic•Rochester, MN

About The Position

The Sr. Quality Analyst, FDA Regulated Manufacturing is responsible for oversight of quality and regulatory compliance for product manufacturing activities. The Sr. Quality Analyst directs the work 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. The Sr. Quality Analyst 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 the 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.

Requirements

Knowledge and experience in the application of laws, regulations, and guidance documents related to FDA regulated industries (biologics, pharmaceuticals, 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.
Analytical and critical thinking skills.
Must be flexible and capable of adapting to and facilitating change.
Should be very detail-oriented.
Ability to work independently and productively with minimal direction.
Routinely exercise initiative and sound judgment.
Ability to lead, motivate, and influence others.
Objectivity and professionalism is essential.
Must be experienced in conducting audits.
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.
Must be self-motivated and able to independently schedule workday activities with minimal direction.

Nice To Haves

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 and 5 years’ experience supporting FDA regulated product manufacturing, quality, regulatory, or compliance.
Demonstrated ability to interpret regulations and translate them into compliant, inspection-ready operational practices is highly desired.
Experience working in a research environment is preferred.
ASQ certification in quality and/or GMP principles (e.g., quality process analyst, quality improvement associate, etc.) is strongly encouraged.

Responsibilities

Oversight of quality and regulatory compliance for product manufacturing activities.
Identify and reduce regulatory, accreditation, and compliance risk by continuous monitoring and evaluating current facility policies and practices.
Ensure compliance is built into the operational systems.
Oversee manufacturing compliance by making interpretations and developing executive summaries of regulatory and compliance information.
Maintain registration information.
Communicate with external regulatory and accreditation agencies.
Communicate and work effectively with leadership to take necessary actions to mitigate identified risks.
Accountable for the effective implementation of the Quality Management System (QMS).
Serve as the subject matter expert on the policies, processes and procedures of the QMS.
Develop a broad knowledge of the practice, business and technology as it relates to product manufacturing.
Remain abreast of current, new, and developing industry trends, regulations, and legal positions related to FDA regulated manufacturing, patient care, and information management.
Conduct audits.