Research Instructor - QA Director

Location
Aurora, CO
Posted
Sep 30, 2017
Institution Type
Four-Year Institution



University of Colorado - School of Medicine

Research Instructor



The Gates Center for Regenerative Medicine has an opening for a full-time faculty position at the Gates Biomanufacturing Facility. The Gates Biomanufacturing Facility is a cGMP manufacturing facility dedicated to the development and manufacture of novel biological therapies for early phase human clinical trials. Reporting to the Chief Operating Officer, this person will be responsible for directing all Quality operations 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.

Job Summary:

Full time position at the Gates Biomanufacturing Facility reporting to The Director of the Gates Center and the COO of the Gates Biomanufacturing Facility.

  • The Director of Quality will build a highly functioning team that can problem solve and manage the Quality/cGMP program at the site. The GBF Quality Program manages all aspects of QA and QC operations for a Phase I and Phase II cGMP Cell Therapy and Protein Biologic contract manufacturing facility. As part of GBF management team, provide proactive and visible leadership to ensure we perform in a spirit of excellence.
  • Provides leadership for all Quality Assurance and Quality Control staff and quality related activities covering: quality management systems, facility management, validation, quality operations, supplier quality, customer compliance, regulatory agency inspections, materials management and continuous improvement.
  • The Director of Quality will partner with the Director of Cell Therapy and Director of Protein Manufacturing to ensure synergistic alignment of Manufacturing Operations & QA/QC functions while ensuring that Quality teams maintain appropriate independence so that there is no conflict of interest between regulatory requirements and day-to-day operational priorities.
  • The Director of Quality will ensure that QA/QC operate as an effective service group to support the day-to-day operations of the Cell Therapy and Protein technical groups.
  • The Director of Quality will partner with the Business Development team in the assessment of new opportunities and providing appropriate Quality and Regulatory input to prospective customers and act as primary contact for discussions on Quality matters with key customers. Director of Quality will interface with clients to establish quality parameters for Scopes of Work, Professional Service Agreements and Quality Agreements including the demonstration of compliance through audits.
  • The Director of Quality will coordinate quality assurance and reporting with School of Medicine Regulatory Compliance and Clinical Research Office and act as primary point of contact with regulatory agencies as requested by Regulatory or Clinical Research offices.


Responsibilities:
  • Communicate with clients on a regular basis to ensure that QA/QC and compliance operations activities meet their expectations.
  • Assess workload and manage QA/QC resource deployment to achieve goals and project timelines. Manages and tracks execution of QA/QC activities versus project timelines.
  • Develop, direct, and maintain the Quality Systems and establish compliant policies, procedures and specifications. Ensure the establishment of an effective manufacturing control regimes.
  • Ensure that the quality system is deployed and is compliant and effective; ensure escalation to Regulatory Compliance and Clinical Research Office and Director of Gates Center of non-compliance or ineffective deployment at site. Report all critical and relevant Quality and Regulatory compliance matters to Regulatory Compliance and Clinical Research Office and Director of Gates Center.
  • Build and maintain the QA & QC teams; ensuring required QA management and quality and QC expertise is available and effective for site operations; ensuring development of staff.
  • Contribute to the development, maintenance and coordination of the campus wide quality systems in line with University requirements, industry best practices / standards and current regulatory requirements (US FDA EMA and rest of world regulatory agencies).
  • Ensure effective internal GMP audit programs are deployed and effective and that the site is "audit ready" and compliant at all times.
  • Ensure batch release in a timely manner, providing quality requirements are met.
  • Oversee testing and timely disposition of commercial and clinical material to allow shipment to customers.
  • Ensure QA review and approval/rejection of all cGMP related procedures, documents and records
  • Enforcement of investigations for non-conformance issues
  • Ensure that all personnel training, investigation, deviation actions, critical documentation and audit actions are completed on time. Ensure necessary training and education is available to support the maintenance of cGMP at the site
  • Ensure risk management principles, the essence of ICHQ10 and a continuous improvement culture are built into QA ways of working.
  • Manage the Quality Assurance budget


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:

  • PhD desired with a minimum of 10+ yrs hands on experience in Quality or Bachelors/Masters with a minimum of 12+ years hands on experience in Quality.
  • 10+ years in a Quality Leadership role, ideally in a cell and gene therapy organization or aseptic-based operation.
  • Prior experience in creating, building, implementing, and managing a Quality function.
  • Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the management of compliance.
  • Strategic leadership and thinking to ensure compliance is delivered cost effectively.
  • Rational persuasion particularly in the discussions with customers.
  • Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.
  • Ability to read, analyze and interpret common scientific, professional and technical journals, governmental regulations and legal documents.
  • Extensive knowledgeable of FDA/EMEA regulatory requirements applicable to cell and gene therapies
  • Ability to apply cGMP regulations and other FDA and international guidelines to all aspects of the position.
  • Strong interpersonal and communication skills, verbal and written


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

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 11296

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: Sep 29, 2017

Closing Date: Ongoing

Posting Contact Name: Tim Gardner

Posting Contact Email: timothy.gardner@ucdenver.edu

Position Number: 00704822

PI99616954