Overview
GMP and Quality Support Manager Jobs in Ontario, Canada at CPDC (Centre for Probe Development and Commercialization)
Title: GMP and Quality Support Manager
Company: CPDC (Centre for Probe Development and Commercialization)
Location: Ontario, Canada
Position Name: GMP and Quality Support Manager
Location: Hybrid (Hamilton-Remote)
Direct Manager: Vice President Quality Operations
Department: Quality
Mission
As a member of the GMP consultancy services team, within the Centre for Probe Development and Commercialization (“CPDC”), the GMP and Quality Support Manager provides technical assistance on GMP compliance and Quality Assurance to various radiopharmaceutical manufacturing sites across Canada with the objectives to help them develop and enhance their level of GMP compliance to meet regulatory expectations, and to support CPDC business expansion objectives.
This role works under the direction of the Vice President of Quality Operations, and actively collaborates with other CPDC departments, external consultants, suppliers, clients, and partners.
Key Accountabilities
Quality Leadership
· The GMP Support Manager will support CPDC’s partners and associated manufacturing sites in their efforts to develop, establish, and improve their Quality Management Systems (QMS), and in their day-to-day Quality Assurance activities, aiming for compliance with applicable GMP regulations and guidelines set forth by applicable regulatory bodies (i.e. Health Canada, FDA, ICH, etc.) for radiopharmaceutical sterile drug manufacturing.
· Perform compliance review of GMP-related documents pertaining batch manufacturing, aseptic process qualification, equipment qualification/calibration, QC and stability testing, environmental monitoring, deviations, quality investigations, change control, CAPA, supplier qualification, process validation, risk assessments, etc.
· Develop and maintain the CPDC document management system according to internal procedures and regulatory expectations.
· Lead and deliver GMP training to CPDC’s partners’ teams, including the preparation of training materials.
· Support the transfer of products and technologies across sites and the associated validation activities.
· Maintain the audit schedule for the CPDC manufacturing sites and suppliers, participates in GMP audits, including preparation and follow-up activities.
· Support the sites’ regulatory inspection readiness, response and remediation activities.
· Build and maintain strong, trust-based relationships with manufacturing sites, suppliers, and other third parties.
· Perform all other duties as assigned.
Competencies
GMP Knowledge: Preference will be given to those candidates with proficiency and experience in managing GMP areas in the pharmaceutical and the radiopharmaceutical industry. Specifically, in-depth understanding of Good Manufacturing Practices (GMP), Health Canada, FDA, and ICH regulations specific to pharmaceuticals and radiopharmaceuticals.
Quality Assurance Principles: Proficient in pharmaceutical quality management systems, including document control, deviation management, CAPA, change control, process validation, batch release, and suppliers’ qualification.
Auditing: Experience in participating in internal and external GMP audits.
Training: Ability to deliver effective GMP training for staff, ensuring understanding of quality systems, compliance, and procedures.
Documentation review: Ability to identify GMP gaps during the review of SOPs, protocols, and reports and to propose changes to ensure compliance.
Sterility Assurance: Basic knowledge of aseptic techniques, environmental monitoring, clean room qualification, and sterilization methods in sterile manufacturing environments.
Laboratory Testing: Familiarity with quality control testing methods, including HPLC, TLC, GC, sterility, endotoxins, etc., along with data integrity and compliance with Good Laboratory Practices (GLP).
Skills
Attention to Detail: Candidate must have a strong attention to detail and focus on data review, documentation, and compliance checks.
Analytical Thinking: Ability to analyze quality issues, identify appropriate corrective and preventive actions, assist in root cause analysis and quality risk assessments.
Communication Skills: Clear technical writing and verbal communication for effective collaboration with internal teams, suppliers, and clients.
Self-Motivation: Ability to work independently on projects for extended periods, maintaining drive and focus on goals, without becoming isolated and ensuring important matters are timely communicated to their manager.
Teamwork: Ability to actively collaborate with CPDC’s Quality team, work in multidisciplinary teams and to support senior consultants.
Adaptability: Flexibility to work on diverse projects and to adapt to evolving regulatory requirements, and to a growing business environment.
Time management and prioritization: The candidate will be expected to balance several projects simultaneously and prioritize their workflow.
Working Environment
CPDC operates with a hybrid work model, allowing employees to work from home most days of the week and are expected to work one, or two days a week as a group at our Hamilton offices, as well as across Canada approximately on a monthly basis.
Education and Experience
· BSc./MSC. in a relevant scientific discipline, preferable in chemistry or microbiology
· 5+ years of QA experience in the pharmaceutical, radiopharmaceutical or biotech industry.
· Experience in sterile manufacturing environments.
· Knowledge in laboratory testing and validation.
· Knowledge of the radiopharmaceutical industry is an asset.
CPDC is a “not-for-profit” corporation founded in 2008 to advance probe (chemical agents that will carry medical isotopes to targets in the body) discovery and development, provide a reliable supply of radiopharmaceuticals, and create sustainable commercial entities in the radiopharmaceutical industry. CPDC’s mission is to be a global leader in the radiopharmaceutical industry dedicated to transforming patient’s lives by advancing high quality drugs for the diagnosis and treatment of diseases CPDC has raised over $49M in federal & provincial government funding and has created 4 spinoff companies to date.
