MUST BE CURRENTLY ELIGIBLE TO WORK IN CANADA. This is not a remote position, candidate must be willing to work in Laval, Quebec.

Quality Assurance Manager – Vaccines and Biologics

Biodextris is a rapidly growing Contract Development and Manufacturing Organization specializing in biologics and vaccines. Specific service areas include analytical method development, molecular characterization, Quality Control testing, bioprocess development, and GMP manufacturing services for products in research, pre-clinical and early-phase clinical studies.  Biodextris is a quality driven, responsive partner with strong global experience and deep scientific expertise. Our mission is to offer to our client transparency and a collaborative approach.

Position Overview:

The Quality Assurance Manager is the head of quality at Biodextris and is responsible for the overall quality approach of the company. He or she manages the QA department, ensuring that the team provides guidance to operational departments (analytical laboratory and GMP manufacturing) to ensure compliant operations. He or she ensures implementation, execution and maintenance of all quality systems and programs, manages quality risks and interfaces with stakeholders, including clients, on quality-related matters. The Quality Assurance Manager will ensure continuous Biodextris compliance with Canadian, US and European quality compliance regulations and requirements.

This position is offered as a permanent position.

General Duties:

• Maintain an in-depth knowledge and understanding of current GMPs, including GUI-0036 and GUI-0001
• Act as a catalyst for change and improvement in performance and quality
• Ensures that all GMP-impacting activities are performed in compliance with regulatory requirements and procedures
• Ensure systems are in place and in use to provide adequate assurance of data integrity
• Determine QA input on operational strategies for new and ongoing analytical and/or manufacturing projects
• Serve as quality point of contact across the organization for all project-specific decisions that can impact quality, including change control approach, material management, validation strategy (method/process) and requirements for batch release
• Provide QA review and approval to processes that impact generation of data (e.g.: validation, calibration and maintenance activities)
• Serve as Quality representative to perform quality review and approval of SOPs, master batch records, standards, specifications, memo, logs, deviations/OOS reports, change controls, CAPAs, study reports
• Provide quality release of product, review and approval of related documentation
• Release incoming samples and materials
• Qualify and approve vendors (including QA agreements)
• Review and approve environmental monitoring data
• Review and approve Water Sampling data
• Perform other quality related tasks, as needed

Role-specific Duties:

• Determine overall QA strategy for the organization
• Serve as quality point of contact across the organization for all major decisions that can impact quality, including policies, systems and the quality resources for their implementation
• Maintain an in-depth knowledge and understanding of current GMP.
• Perform impact assessments of new relevant regulations, policies and guidelines
• Ensure the integrity and traceability of all data generated and reported.
• Work with operating staff to establish compliant procedures, standards, systems and procedures
• Act as a catalyst for change and improvement in performance and quality
• Assess customer requirements and ensure that these are met
• Present and review Quality metrics during Management review meetings ensuring that processes are followed, and no failures/deviations are overseen
• Management of Audits (internal, client, supplier, regulatory inspections)
• Determination of training needs for QA department
• Provide training regarding quality system
• Management of quality risks
• Perform other quality related tasks as needed
• Serve as Management Representative

Specific Responsibilities:

• Under minimal supervision, authors and revises deviation records, preventative actions and other related cGMP documents in a timely manner.
• Becomes familiar with analytical method development and qualification processes, stability testing, materials management, systems, and technologies to facilitate the accurate completion of responsibilities.
• Track/monitor and provide timely, accurate information regarding status of open tasks.
• Actively engage in Inspection Readiness activities and teams.
• Provide guidance to write and revise SOPs (Standard Operating Procedures) when gaps are identified.
• May provide support to internal and client audits as needed.
• Responsible for exhibiting professional behavior with internal and external associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Collaborate with Supervisor to optimize QC processes.
• Creates and reviews quality procedural documents and change control documents
• Follow company policies and procedures.
• Complete SOP training for new and revised procedures prior to activity performance.
• Adhere to established security policies.
• Maintain Good Documentation Practices when completing GMP documents.
• Maintain personal training file and assist in training of other staff.
• Perform additional duties as assigned.

Required Education skills and abilities:

• M.Sc or equivalent in Bioprocessing related field such as Biology, Biotechnology, Biochemistry or Microbiology or equivalent and 7+ years pharma/biotech work experience
• B.Sc or equivalent in a Bioprocessing related filed such as Biology, Biotechnology, Biochemistry or Microbiology or equivalent and 10+ years work experience
• 5 to 7 years prior experience in a QA or QC role, preferably in a biologics or vaccines manufacturing facility
• Experience in the implementation or enforcement of HC GUI-0036 requirements
• Experience in the implementation or enforcement of HC GUI-0001 requirements or USFDA CFR part 210/211 requirements
• Experience with USFDA CFR part 314 would be an asset

Application: Send resume and cover letter by email to info@biodextris.com.