Sr. Director of Quality Assurance - Center for Regenerative Medicine
Company: Mayo Foundation for Medical Education and Research
Posted on: May 15, 2022
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
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
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
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.
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.
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.
Hours / Pay period
Monday thru Friday, Days. Additional hours as needed to meet the
demands of the position.
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
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
Didn't find what you're looking for? Search again!