Quality Assurance Training, Lead

Requirements

• 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.
• Travel Required:
• 10% of the Time
• Shift:
• Day
• Duration:
• No End Date
• Job Function:
• Quality/Regulatory

Benefits

Additional Information

Job Description BIOVECTRA, now a part of Agilent, 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 searching for a Quality Assurance Training, Lead. This role will focus on designing and implementing quality assurance (QA) training programs that align with safety, regulatory standards, and business goals. It involves enhancing staff competency by identifying skill gaps and creating targeted learning plans. 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: Partnering with functional areas to conduct ongoing needs analysis, training effectiveness checks, and trend results, as appropriate Knowledge of Health Canada, FDA, and ICH Q10 regulatory expectations for personnel training and qualification Experience with LMS or equivalent electronic training management system Serving as the primary training system representative during regulatory inspections Partnering with global training and quality leadership to ensure alignment of site training practices with enterprise-wide standards and governance frameworks Coordinating training program execution across multiple BioVectra sites (PEI and Windsor) Establishing and maintaining a trainer qualification program Partnering with functional areas to develop training materials and knowledge assessments for area SOP's review knowledge assessments Liaising with functional departments to draft, implement, approve, and revise training materials Facilitating/Supporting instructor led training courses, including annual cGMP Training, as appropriate This role has the option of working onsite at our Windsor, NS or Charlottetown, PEI facility

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Company Intel

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