Quality Assurance Manager

Location
Aurora, CO
Posted
Oct 10, 2018
Institution Type
Four-Year Institution



*Applications are accepted electronically ONLY at www.cu.edu/cu-careers.*



University of Colorado Denver l Anschutz Medical Campus

School of Medicine | Department of Dermatology, Gates Biomanufacturing Facility

Quality Assurance Manager (Business Services Manager)

Position #748224 - Requisition 13878



The Department of Dermatology, Gates Biomanufacturing Facility has an opening for a full-time, University Staff (unclassified) Quality Assurance Manager (Business Services Manager) position.



The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002. Read CU Anschutz Quick Facts here.

Job Summary:

Gates Biomanufacturing Facility (GBF) located on the University of Colorado | Anschutz Medical Campus is seeking a Quality Assurance Manager for our Good Manufacturing Practice (GMP) cell therapy and biologics production and testing facility. GBF serves as a development and manufacturing organization for the University of Colorado, UCHealth and Children's Hospital of Colorado as well as industry based partners. This critical position will manage all Quality Assurance and Compliance activities within the facility, and establish and maintain all Quality Systems. The Quality Assurance Manager is responsible to communicate to all GBF employees and external collaborators the operational quality standards and policies required by GBF clients, the University of Colorado, and applicable state and federal regulations. This role is ultimately responsible for managing the daily quality activities around the development and manufacture of both cell therapy and biologics intended for to support early-phase clinical trials, and reports to the Director of Quality.

In this fast-paced environment, the QA Manager is expected to establish, proactively provide guidance to staff, and uphold quality policies and standards for the Facility. In addition, the QA Manager will actively engage with staff at all levels to provide input and risk management to uphold critical product quality attributes and product safety. Operationally, this role will maintain the overall electronic quality management system, which includes document control, batch release, deviations/investigations, corrective and preventive actions, vendor management, personnel training, asset management, and equipment/instrument qualification and calibration programs. This position also manages and coaches quality assurance team members, promotes a cohesive team environment as well as individual team member development, and maintains a high level of engagement towards quality throughout the environment.

Examples of Work Performed:
  • Establish, author, review and approve Facility standard operating procedures (SOPs), Quality policies and Quality Agreements.
  • Guide in-process, bulk drug substance and final product batch release efforts including master and executed batch record review/approval, material disposition, and shipment of product to local and national clinical sites.
  • Provide site-wide guidance for deviations, investigations, corrective/preventive actions (CAPAs) and change control implementation. Review and approve deviation investigations and CAPA plans.
  • Serve as member of the GBF site change control and material review boards.
  • Plan, review, execute and approve facility and equipment Installation, Operational, and Performance qualifications.
  • Administrate and conduct internal and external audits; responsible for the scheduling and completion of client and vendor audits; represent GBF Quality organization during auditor and client site visits.
  • Maintain Facility compliance with University, local, state and federal regulations, and applicable client and third-party requirements.
  • Develop QA key performance indicators (KPI) metric reporting system and coordinate reporting to Facility management and University representatives.
  • Recruit, supervise, develop, and mentor members of the Quality organization including the creation of professional and personal development plans, and yearly performance reviews.
  • Partner with management and employees to ensure EH+S compliance as mandated by federal, state, and local regulations and adherence to GBF procedures and standard practices.

Salary and Benefits:

The hiring salary for this position is commensurate with skills and experience. This position is not eligible for overtime compensation.

The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications

Minimum Qualifications:
  • Bachelor's degree in a biological science from an accredited institution.
  • This position requires extensive, diverse and progressively responsible quality assurance experience in a regulated environment.
  • Three (3) years of experience managing a Quality Assurance group in a GMP pharmaceutical/biologics or cell therapy contract manufacturing setting.
  • Experience in managing the release and distribution of bulk drug substances and finished products to support early stage (i.e. Phase I and Phase II) clinical trials.

Preferred Qualifications:
  • A master's or higher earned degree in a biological science from an accredited institution.
  • Eight (8) or more years' of quality assurance experience in a regulated environment.
  • Six Sigma certification (green or black belt).
  • ASQ CQA/CQE Certification.

Competencies/Knowledge, Skills and Abilities:
  • Proven familiarity with the implementation and management of an electronic Quality Management System (e.g. Trackwise, Documentum, etc.) highly desirable.
  • Strong leadership, organization and project management skills; able to perform/lead a variety of tasks, planned and unplanned with an exceptionally high level of quality under timelines.
  • Demonstrated ability to recruit, develop and retain a high performance, results oriented team within a collaborative environment.
  • Highly effective communication and interpersonal skills (formal/informal); able to communicate and work with all levels of the organization and University administration.
  • Proficient with common software applications/programs (MS Word, Excel, PowerPoint, etc.).
  • Ability to communicate effectively, both in writing and orally.
  • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
  • Outstanding customer service skills.
  • Demonstrated commitment and leadership ability to advance diversity and inclusion.

Diversity and Equity:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Office of Equity by email at equity_ada@ucdenver.edu or by phone at (303) 315-2567.

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers. * REQUIRED APPLICATION MATERIALS: 1). A cover letter of application which specifically addresses the job requirements and outlines qualifications. 2). A current resume/CV. 3). List of 3-5 professional references. Questions should be directed to Kia Silverman at Kia.Silverman@ucdenver.edu.

Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. We will notify you prior to contacting both on and off-list references.

Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:APPLICATION DEADLINE: Review of applications will begin immediately and will continue until the position is filled.



Job Category: Business Services

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20143 - SOM-Dermatology

Schedule: Full-time

Posting Date: Jun 11, 2018

Closing Date: Ongoing

Posting Contact Name: Kia Silverman

Posting Contact Email: Kia.Silverman@ucdenver.edu

Position Number: 00748224

PI104824577

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