Associate Director of Quality

Location
Aurora, CO
Posted
Aug 23, 2017
Executive Administration Jobs
C-Level & Executive Directors
Institution Type
Four-Year Institution



University of Colorado - School of Medicine

Research Instructor - Associate Director of Quality





The Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology has an opening for a full-time Research Instructor at the newly established Gates Biomanufacturing Facility. The Gates Biomanufacturing Facility is an academic cGMP manufacturing facility dedicated to the development and manufacture of novel biological therapies for early phase human clinical trials. This position will be responsible for the day to day management of the Quality Management System at the Gates Biomanufacturing Facility.



Open in 2015, the Gates Biomanufacturing Facility (GBF) is a cGMP manufacturing facility operated in partnership among the Gates Center, University of Colorado Anschutz Medical Campus, University of Colorado School of Medicine, Children's Hospital Colorado, University of Colorado Health and the Gates Frontiers Fund. With expertise in cell-based therapies, protein biologics, quality assurance and control our mission is to o help our clients accelerate the translation of their discoveries into human clinical trials as efficiently and cost effectively as possible.

Established in 2006 with a generous gift in Charles Gates' memory, the Gates Center for regenerative Medicine is a world-class center headquartered on the University of Colorado Anschutz Medical Campus. Operating within this interconnected campus, the Gates Center brings together its medical research and clinician members to utilize the center's state-of-the-art laboratory facilities and technology. Members also benefit from the collaboration the center fosters and the services it provides in the areas of marketing and philanthropy, education and outreach, and commercialization support designed to accelerate discoveries into clinical practice as quickly as possible. The Gates Center is a multi-institutional center currently comprised of approximately 100 members from the University of Colorado Anschutz Medical Campus and CU Boulder, Colorado State University, Colorado School of Mines and private industry.

CU Anschutz is one of the world's newest education, research and patient care facilities and the largest academic health center from Chicago to the West Coast, north of Texas. The University of Colorado Anschutz Medical Campus (CU Anschutz) is the largest academic health center in the Rocky Mountain region. The campus combines interdisciplinary teaching, research and clinical facilities to prepare the region's future health care professionals, provide the best available health care at two nationally recognized hospitals and be a national leader in life sciences research. Annually, CU Anschutz medical professionals educate 4,000 degree-seeking future health professionals, provide 1.5 million patient visits, and are awarded approximately $400 million in research grants.

The University of Colorado Denver seeks a Quality Engineer to work in the Gates Biomanufacturing Facility located near the Anschutz Medical Campus in Aurora. The University of Colorado Denver 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. The university has proudly positioned itself as one of the top urban research universities in the country. The Gates Biomanufacturing Facility is one of the core facilities used to differentiate the university in both regenerative medicines as well as traditional biotech streams.



Job Responsibilities:


  • Understand the quality management system strategy and direct day to day administration of a quality/cGMP based program for the contract manufacturing of protein biologics and regenerative medicine therapies for phase 1 and 2 clinical trials.
  • Work in a multidisciplinary, multi-accreditation, and regulatory space for protein biologics and regenerative medicine therapies.
  • Perform as an individual contributor by developing and implementing key quality operational SOPs; refine existing programs for enhanced compliance as assigned by Director of Quality Assurance.
  • Role will develop deliverables (i.e., SOPs, review of documentation, protocols) on a weekly/daily basis for the maturation and continuous improvement of the site quality management system.
    • Assist in the Review and release of:
    • batch records
    • testing results
    • receiving inspection results
    • other testing
    • critical documents,
    • specifications,
    • procedures
    • other technical documents.


  • Brief Director of Quality Assurance on quality system health on a consistent basis:
    • Results from key equipment, utilities, facilities, assay and process validation protocols.
    • Status of client requirements and propose solutions for handling client requests or situations
    • Performance and health of the QMS via reports, managing issues to resolution and in conformance with quality metrics and compliance requirements.
    • Compliance of site training program to quality objectives.
    • Key performance indicators (KPI) to quality objectives.
  • Review contracts for cGMP services.
  • Manage critical incidents in conjunction with Non-Conformance Processes
  • Manage CMC document provision program for clients.
  • Administer risk management program elements including identification and mitigation of new process risks particularly through FMEA, Fault Tree Analysis and other Risk tools.
  • Compile information and results into meaningful formats to ensure content is appropriately represented.
  • Full time position at the Gates Biomanufacturing Facility located nearby the Anschutz Medical Campus. The position may require weekend work and work outside of normal work hours to accommodate processes which cross shifts. While not typical, this irregularity of work hours should be expected.
  • Report to the Director of Quality Assurance
  • Provide exceptional customer service to users of the facility.
  • Work in a professional and collaborative manner with coworkers and prospective users.


Salary and Benefits:



Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.

The University of Colorado Denver 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 strongly supports the principle of diversity. 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 Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.

Qualifications

Required Qualifications:

  • A minimum of 5 years of Quality Assurance Management/Director level experience in commercial FDA regulated biologics or cell therapies or applicable field.
  • Masters Degree in an Engineering discipline or equivalent. Life sciences degrees are applicable.
  • Extensive knowledge of 21 CFR 210, 211, and 600.
  • Experience in reading and understanding contractual documents for their administration.
  • Excellent leadership skills to support GBF employees in the removal of obstacles, and collaboration in development of solutions to maintain compliance of quality management system requirements and University Rules.
  • Ability to articulate applicant's quality philosophy, applicable regulations and their relationship to patient health.
  • Excellent communication skills in both written as well as presentation of data.
  • Experience working and familiar with gowning practices for a clean room environment.
  • A team-oriented, self-starter capable of operating independently in a start-up environment.
  • Complete understanding of investigation methods, documentation of, and appropriate quality disposition of conformance issues. This includes NCR, CAPA, OOS, OOT as well as deviations.
  • Advanced understanding of IT, databases, spreadsheets, word processing including formatting of documents (style sheets) and use of fields.



Preferred Qualifications:

  • A minimum of 8 years of Quality Assurance Management/Director level experience in commercial FDA regulated biologics or cell therapies or applicable field.
  • Advanced degree in applicable field and/or an MBA.
  • Knowledge of pharmaceutical operations from supply chain through manufacturing. Experience as a key resource in the establishment of a facility is acceptable
  • Deep understanding of ICH Quality Guidelines
  • Deep knowledge of 21 CFR 210, 211, HTCP/1271, 820 and 600.
  • Experience in the development of (or authoring for legal review) contractual documents for site use.
  • Regulatory background in provision of IND/BLA material (biologics)
  • Multiple experiences in successfully implementing quality management systems.
  • SME understanding Quality and its application to multiple regulatory areas.
  • SME understanding of aseptic technique and environmental monitoring.
  • Experience working in a JIT manufacturing setting related to BOM assemblies as well as finished product.
  • Experience working with multiple client driven projects and timelines.
  • Experience with automated quality management systems


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

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 10819

When applying, applicants must include:
  1. A letter of application which specifically addresses the job requirements and outlines qualifications
  2. A current Resume/CV
  3. The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.

Please do not submit any of your application material (via email) to the job posting contact.



Job Category: Faculty

Primary Location: Aurora

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

Schedule: Full-time

Posting Date: Aug 22, 2017

Closing Date: Ongoing

Posting Contact Name: Gabe Orsoco

Posting Contact Email: gabriel.orosco@ucdenver.edu

Position Number: 00689259

PI99130936