Quality Assurance Supervisor

**Job Overview**
Responsible for providing assurance to the Novum Pharmaceutical Research Services (NVM) management team that the facilities, equipment, personnel, methods, practices, records, controls and services received are in compliance with the Health Canada Regulatory Requirements, NVM Approved standards/ procedures and other applicable regulatory requirements (i.e. US FDA, EMA, OECD principle of GLP). Responsible for Overseeing archiving related activities.

**Responsibilities**
- Responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practice, records, and controls are in accordance with the 21 CFR Part 58 and OECD Principles of Good Laboratory Practices.
- Conducts retrospective study-based audits for compliance to Protocol, NVM-Toronto Standards (i.e. Policies, SOPs), Health Canada Regulatory requirements (Division 5 Part C) and other applicable regulatory requirements (US FDA, EMA).
- Inspect each non-clinical laboratory study at required intervals adequate to assure the integrity of the study.
- Periodically submit to management, principal investigator and/or study director written audit reports on each study summarizing the audit observations and follow-up on agreed upon timelines until resolution.
- Hosts the QRM as per the SOP requirement and to coordinate the preparations of the meeting.
- Tracks the change controls for the changes made in applicable documents, systems or processes.
- Updates and maintains the Vendor reassessment Calendar and Validated Electronic Software list.
- Review the method validation and bioanalytical reports and raw data in accordance with SOPs, regulatory and Sponsor requirements.
- Maintain written records of each periodic inspection performed.
- Assist in maintaining a copy of a master schedule sheet of all non-clinical laboratory studies.
- Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
- Responsible for reviewing Deviation Reports _I _Investigation Report and Corrective Action.
- Hosts and manage Regulatory Inspections/Sponsor Audits and to manage the necessary preparations for the same. To respond to the queries from regulatory bodies/sponsor audits and to generate the regulatory listings.
- Prepares for and conducts Internal Facility Audits of NVM as per internal procedures and identify areas for improvements and communication to department management.
- To conduct the Supplier Audits and following up on corrective actions to resolution per NVM procedures.
- Write, revise and review Standard Operating Procedure (SOP) in compliance with NVM Standards/Policies and participate in the review cycle of the SOPs. Notifies QA Management of all Critical and Major Deviations/Observations/Deficiencies.
- Prepare action plans resulting from regulatory inspections, or client site audits.
- Identify areas for continuous Improvement within the organization.
- Play a vital role in the training/mentoring of NVM staff with regards to NVM approved standards (i.e., SOPs) and regulatory requirements.
- Exercise health precautions to minimize risk to self and to ensure the integrity of the study. Communicate to the appropriate person with any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.
- Assist with hiring and training of QA staff.
- Assign QA tasks to QA Auditors and oversee the day-to-day operations of the QA department.
- Assess QA staff performance and assist with conducting annual performance reviews.
- Perform additional related duties as assigned.

**Qualifications**
- Minimum B.Sc. degree in scientific discipline or equivalent.
- 5 years of working experience in the clinical research/CRO industries with a strong understanding of Quality Control and/or Quality Assurance processes.
- Previous experience in a QA/QC capacity preferred.
- Knowledge of Health Canada regulatory requirements pertaining to Good Clinical Practices (GCP) and ICH Guidance Documents.
- Good Computer Skills. Proficient use of relevant computer software packages in a Windows environment (i.e. MS Word, Excel, and PowerPoint).
- Strong command of the English language. Excellent verbal, written and interpersonal skills are required.
- Ability to interact with all departments on a professional level.

**Job Types**: Full-time, Permanent

Schedule:

- Monday to Friday

Work Location: In person