Quality Assurance Training, Lead

JOB DESCRIPTION BIOVECTRA, now a part of Agilent’s Advanced Therapeutics Division (ATD), is recognized as a leader in the contract development and manufacturing space of active pharmaceutical ingredients specializing in clinical-to-commercial scale production for microbial fermentation, synthetic small molecules including ADC, HPAPI, plasmid DNA, mRNA, LNP and sterile filling capabilities. With over 650 employees at both the Windsor, NS and Charlottetown, PEI sites, BIOVECTRA supports over 100 clients, including over 20 top pharma and biotech companies. Agilent is currently hiring for the ATD Canada Learning Lead. This role is responsible for the oversight of ATD learning initiatives, ensuring alignment with regulatory and corporate quality directives, and leading learning programs across all three (3) ATD-Canada sites.. Responsible for identification, creation, and delivery of key learning programs to personnel across our Windsor, NS and Charlottetown, PEI facilities, ensuring training programs align with applicable regulatory requirements including Health Canada GUI-0001, 21 CFR 211.25, ICH Q10, and applicable GMP standards. The responsibilities will include: * Partners with key leaders across Global Operations, and the ATD business, in identifying training opportunities, support content development, and evaluate learning effectiveness of critical learning compliance programs. * Facilitate training classes, as necessary, to support personnel development. * Manages the overall schedule, experience, and delivery of key ATD-Canada training programs, including new employee onboarding and annual Good Manufacturing Practices (GMP) training. * Assists with maintenance of the Learning Management System (LMS), including maintenance of learning records, oversight of on-time training, and providing relevant materials during audits and/or inspections. * Oversees the ATD-Canada Learning function, ensuring oversight of learning programs, curriculums, and effectiveness of learning solutions. * Develop, maintain, trend, and continuously improve ATD-Canada site training programs, including conducting effectiveness check(s) as needed. * Investigates and responds to Quality System improvements identified in the training system (e.g. CAPA, NCR, inspection finding). * Establishing, and maintaining, a newly developed trainer qualification program * Facilitating/Supporting instructor led training courses, including annual cGMP Training, as appropriate This role will be responsible for onsite support at our Windsor, NS or Charlottetown, PEI facility and will be required to be available for on-site support at both locations. Travel required will be 50%. This role will have the option to have the home base facility in Charlottetown PEI or Windsor, NS. QUALIFICATIONS Required: * Post-Secondary Education * Prior experience in a GMP-regulated quality * Four years of relevant experience and/or training and management of teams within a biotech or pharmaceutical environment * Exceptional facilitation and presentation skills * Experience with Quality systems Desired: * Train the Trainer Certified * API facility experience * Rise Articulate platform knowledge * LMS experience * Knowledge of metrics/trending Additional Details This job has a full time weekly schedule. The full-time equivalent pay range for this position is $81,022.00 - $126,596.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws. TRAVEL REQUIRED: 10% of the Time SHIFT: Day DURATION: No End Date JOB FUNCTION: Quality/Regulatory

The Lead is responsible for overseeing ATD learning initiatives and ensuring all training programs align with regulatory requirements such as GMP and Health Canada standards. They will manage the Learning Management System, facilitate training sessions, and lead the development of site-wide training curriculums.

Candidates must have post-secondary education and at least four years of experience in a GMP-regulated quality environment. Strong facilitation skills and experience managing teams within the biotech or pharmaceutical industry are required.

• Bonus • Stock • Benefits

• Assurance qualitéSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• GMP
• Quality Assurance
• Training Facilitation
• LMS Management
• Regulatory Compliance
• CAPA
• NCR
• Instructional Design
• Biotech
• Pharmaceutical
• Presentation Skills
• Quality Systems
• Curriculum Development
• Auditing
• Trainer Qualification
• Active Pharmaceutical Ingredients
• Small Molecules
• Instructor-Led Training
• Train The Trainer
• Fermentation
• Title 21 Of The Code Of Federal Regulations
• Quality Management Systems
• Application Programming Interface (API)
• Biotechnology
• Management
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Content Development
• Learning Management Systems
• Graphical User Interface
• Local Number Portability
• MRNAs
• Employee Onboarding
• Operations
• Pharmaceuticals
• Presentations

• Healthcare
• Manufacturing
• Science & Research
• Management & Leadership
• Education
• Quality Assurance Trainee
• Director of Quality Assurance
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers

Formation minimale

Études secondaires

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine