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Sr. Director of Quality Assurance - Center for Regenerative Medicine

Company: Mayo Foundation for Medical Education and Research
Location: Rochester
Posted on: May 15, 2022

Job Description:

Why Mayo Clinic
Mayo Clinic is the nation's best hospital (U.S. News & World Report, 2020-2021) and ranked #1 in more specialties than any other care provider. We have a vast array of opportunities ranging from Nursing, Clinical, to Finance, IT, Administrative, Research and Support Services to name a few. Across all locations, you'll find career opportunities that support diversity, equity and inclusion. At Mayo Clinic, we invest in you with opportunities for growth and development and our benefits and compensation package are highly competitive. We invite you to be a part of our team where you'll discover a culture of teamwork, professionalism, mutual respect, and most importantly, a life-changing career!

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

Position description
The Senior Director, Quality Assurance will report to the Associate Administrator and the Director, Center for Regenerative Medicine (CRM) in Research Administrative Services and will have leadership responsibilities for ensuring cGMP quality and regulatory manufacturing compliance for non-clinical and clinical (Phase 1 & 2) materials. Will champion the evolution of the quality culture supporting clinical translation and manufacturing for the enterprise which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. The Director will supervise and provide leadership and direction to Quality assurance staff.

The Sr. Director of Quality Assurance is accountable for ensuring full quality and regulatory compliance of the manufacturing facilities, while driving process effectiveness and efficiency at the sites. Serves as a resource for related development activities such as Process Development Transfer, Cell Line Development, and Analytical Assay Development. Reviews records (e.g., manufacturing batch records, release & stability testing data, SOPs, Deviations, Change Requests, and Corrective and Preventative Action (CAPA) reports). Participates in Risk Assessment and Mitigation evaluation activities. Responsible for hosting customers compliance and site qualification audits. Provides site Quality System Overview training, cGMP Orientation and Annual Refresher training, Good Documentation Practices training, as well as Deviation Writing training. Has the authority to stop production, issue product holds, release products and sign off on project milestones. Oversees all Quality related communications and training requirements for all site employees. Oversees the correction Action/Preventative Action activities and Complaint Handling Programs.

Reports on Quality System effectiveness and requirements to management reviews. In addition, the Director will partner closely with the CRM Director, Associate Directors, Deputy Directors and other Center leaders to develop and execute on the 2030 strategic priorities for CRM in alignment with, and in support of, the Enterprise Biomanufacturing Strategy.

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.

Additional qualifications
Quality Assurance/Quality Engineering experience in the bio manufacturing industry or Pharma GMP experience in quality assurance. Prior upstream/downstream experience in drug bio manufacturing is preferred. Excellent organizational, presentation, meeting facilitation and technical writing skills. Excellent written and verbal communication skills Experienced in managing project teams and working cross - functionally and at global level. Demonstrated collaboration & conflict resolution skills, demonstrated expertise to effectively communicate within all levels of the organization.

Ability to manage tasks independently and make independent quality decisions. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies. Ability to travel to perform/support audits as needed. Strong PC literacy required; Microsoft Office skills (Outlook, Word, Excel, PowerPoint).

License or certification
American Society for Quality (ASQ) certification in quality and/or GMP principles (e.g., quality process analyst, quality improvement associate, etc.), ISO certification is preferred.

Exemption status

Compensation Detail
Education, experience and tenure may be considered along with internal equity when job offers are extended. The minimum salary every 2 weeks is $5,591.20, based on a full-time position.

Benefits eligible

Full Time

Hours / Pay period

Schedule details
Monday thru Friday, Days. Additional hours as needed to meet the demands of the position.

Weekend schedule
As needed.


International Assignment

Site description
Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.

Kaela Peterson

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.

Keywords: Mayo Foundation for Medical Education and Research, Rochester , Sr. Director of Quality Assurance - Center for Regenerative Medicine, Executive , Rochester, New York

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