Director, Quality Assurance, CMSU

Rochester, NY

GENERAL PURPOSE:

Oversees specific federal regulatory requirements to provide the University with oversight of high priority, federally regulated research compliance areas, and perform the following, on behalf of the Center for Health and Technology:

  • Manage, direct and oversee all aspects of internal and external quality and compliance systems relating to routine daily operations as well as the establishment of new quality standards and compliance systems supporting projects with territories outside of the United States and North America. Working closely with the Executive Director of Strategic Initiatives, continually modify, as necessary, current quality systems to comply with the Medical Device regulation (21 CFR Part 820) and the European Commission (EU) Clinical Trials Directive assuring the safe and compliant handling of investigational drugs and devices.

  • Assure compliance with the elements of the EU Clinical Trial Directive so as to position and maintain CMSU quality systems as meeting or exceeding those standards. Direct university risk management for GMP research projects.

  • Manage, direct and oversee implementation and ongoing compliance with the Medical Device Regulations through the establishment of a Quality System Review (QSR) Program that combines the core elements of the Corrective and Preventative Action Program (CAPA), Internal audit program, Vendor qualification and management programs, Continuous Quality Improvement (CQI) program and the Quality Assurance Technical working group. As lead QSR Manager, work closely with CMSU Leadership and other CHeT senior management staff to assure the CMSU is operating in compliance with quality standards as set forth in 21CFR 820.

  • This position is responsible for developing, implementing, maintaining and providing leadership, strategic direction and oversight of compliance and training activities for FDA regulated research activities. The position ensures that all clinical research projects are carried out to the standards set forth by the International Conference on Harmonization (ICH) covering Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), for both FDA and EU regulations covering investigational drugs and devices.

RESPONSIBILITIES:

  • Direct the activities of the Quality Assurance Compliance Group within the CMSU. This group oversees all aspects of Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices associated with CMSU’s compliance with NYS, Federal, and ICH Regulations and other regulatory authorities. Responsible for overseeing, developing, and coordinating the delivery of appropriate GMP training on at least an annual basis for all CMSU personnel. Provide compliance consulting services to the University as needed.

  • Provide compliance support for the release of clinical trial supplies to allow for timely distribution in accordance with the international standards of GCP/GMP regulations and client requirements. Conduct batch and production record reviews, as necessary liaise with external vendors to ensure compliance with project and regulatory standards

  • Administration of all internal Quality Assurance (QA) systems including investigational drug and device procedures and processes – CAPA and CQI.

  • Input and approval authority into all department operating policies and standard operating procedures to ensure federal and international regulatory standards are met.

  • Responsible for the identification, budget/contract negotiation, implementation, validation, and user acceptance testing of all CMSU technology, including the inventory management system, in conjunction with the CHeT IT support team. Ensure all staff are trained on new technology at the time of implementation, and at least annually thereafter and as new hires come on board. Continually research industry trends for additional technology from which CMSU would benefit related to cGMP compliance, streamline procedures, cost reductions, etc. Obtain proposals, vet vendors, and develop annual technology budget for new purchases and for routine maintenance of existing technology.

  • Manage, direct, and oversee policies and procedures governing the storage and security of department documentation systems. Implement, direct, and oversee stability and expiry/retest program for all ongoing studies. Interact directly with clients and analytical facilities to obtain needed reports, and extend/terminate stability protocols as dictated by each project. Work in close collaboration with the CMSU & CHeT Leadership and CHeT on all aspects of CMSU operational activities to ensure regulatory and QA requirements are met for all projects.

  • Management of CMSU Quality Personnel

  • Recruit, train, and supervise Quality Group. Recommends or approves action on appointments, promotion, salary or other related personnel issues. Responsible for ongoing and yearly performance evaluations of direct reports. Provides direction to individual staff members for staff development through personal instruction and scheduling participation in professional meetings, institutes, and seminars.

  • Oversee team and ensures that the CMSU facilities and equipment remain in full compliance with all NYS, Federal, and ICH regulations associated with GMPs, GCPs, GLPs, and other regulatory agencies (e.g. OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 & 211.

  • Responsible to ensure that the CMSU’s time and effort is accurately reported by project to the CHET finance team for billing to each project.

  • Manage, direct, and oversee vendor certification and qualification programs and Internal Quality Audit Program.

  • Act as in-house consultant to all clinical research personnel on matters of international regulatory standards as necessary to maintain internal and regulatory compliance. Participate in external and internal inspections from client companies and international regulatory authorities.

Other job duties and projects as assigned.

QUALIFICATIONS:

  • Bachelor’s degree in biology, microbiology, chemistry, chemical engineering, or related scientific field required.

  • 3 years of relevant experience or an equivalent combination of education and experience required.

  • At least 8 years of Quality Assurance and/or Regulatory experience in the pharmaceutical or device industries preferred.

  • 15+ years of experience, regulatory Affairs Certification (RAC), Registered Quality Assurance Professional (RQAP), or similar industry certification preferred.

  • Minimum of 5 years demonstrated effective strategic planning, analytical problem solving, and decision making; managerial and leadership skills and experience preferred.

  • Strong working knowledge of International GCP/GMPs, compliance auditing, QA experience, and GCP/GMP Document Management systems.

  • Strong interpersonal, presentation, written, negotiation, and communication skills, including writing skills.

  • Strong working knowledge of investigational drug and device handling and distribution, as well as the conduct of clinical trials.

  • Strong organizational and computer skills.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

Pay Range

Pay Range: $107,224 - $160,846 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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Location: School of Medicine & Dentistry
Full/Part Time: Full-Time
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