University of Alberta

Regulatory Affairs and Quality Assurance Specialist

Medical Microbiology & Immunology

Competition No.  -    A112636138D1
Closing Date  -    Will remain open until filled.

This position is being reposted. Previous applicants need not apply.

The Li Ka Shing Applied Virology (LKSAV) Group is a collaborative research environment designed to translate and commercialize basic research discoveries. There are ±30 staff from varied disciplines (virologists, chemists, immunologists, computational scientists and GMP manufacturers, etc.) working in the Li Ka Shing Applied Virology Group with more than 12 active projects under development for future clinical testing.

The Regulatory Affairs & Quality Assurance Specialist will be part of one of the LKSAV group's most exciting projects: the development and manufacturing of a vaccine against Hepatitis C. This position will report to the Director of the Li Ka Shing Applied Virology group, Dr. Michael Houghton, and will work in collaboration with the other project members. In collaboration with a senior vaccine regulatory affairs expert, the incumbent will be responsible for regulatory affairs and quality assurance of the manufacturing process for the Hep C vaccine.

The following activities will be conducted in consultation with a senior vaccine regulatory affairs expert.

Duties:

  • Develops and implements quality assurance protocols to ensure compliance with regulatory agencies
  • Coordinates regulatory queries, inspections or audits
  • Manages the preparation of regulatory submissions
  • Provides input to the planning and preparation of responses to requests from Regulatory Agencies
  • Finds and interacts with Contract Research Organizations (CROs) for testing not performed in-house
  • Develops the studies and interacts with CROs/GLP labs for toxicity and clinical studies
  • Drafts, edits and reviews quality assurance documentation (including batch production records)
  • In consultation with the Principal Investigators and the team, develops and documents methods and protocols associated to quality control
  • Responsible for providing training and direction to Quality Assurance (QA) staff
  • Responsible for monitoring QA activities to meet project timelines
  • Analyzes and interprets data relating to quality control
  • Assures that reviewed QA records are compliant to methods, specifications and the groups’s applicable Standard Operating Procedures (SOPs)
  • Manages the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs
  • Initiates out-of-specification investigations in case of OOS
  • In case of a deviation from SOP, initiates a deviation form and investigates, justifies and performs root cause analysis and corrective action

Qualifications:

  • Minimum B.Sc. degree in Biology, Biochemistry or similar scientific discipline; MSc or PhD is desired
  • Minimum 2-3 years experience in a CRO or biotechnology industry or equivalent environment in the areas of quality assurance and regulatory compliance
  • Demonstrated experience in pharmaceutical QC testing and records review
  • Demonstrated experience in OOS Investigation
  • Knowledge of Health Canada, FDA & EMA regulatory requirements pertaining to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ICH Guidance Documents is a must
  • Thorough knowledge of scientific principles pertaining to analytical records review
  • Ability to work independently and with a team of multidisciplinary high-performance professionals
  • Strong written and verbal communication skills are required
  • Experience in vaccine manufacturing processes would be an asset

In accordance with the Trust/Research Academic Staff Agreement, this position has a term of one year, with the possibility of renewal, and offers a comprehensive benefits package found at Faculty & Staff Benefits and an annual salary range of $74,084 to $101,888. Salary is commensurate with experience and qualifications.

To assist the University in complying with mandatory reporting requirements of the Immigration and Refugee Protection Act (R203(3) (e)), please include the first digit of your Canadian Social Insurance Number in your application. If you do not have a Canadian Social Insurance Number, please indicate this in your application.

How to Apply

Apply Online

Note: Online applications are accepted until midnight Mountain Standard Time of the closing date.

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority. If suitable Canadian citizens or permanent residents cannot be found, other individuals will be considered.

The University of Alberta is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, Métis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and the University to apply.