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
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.
10% of the Time
Day
No End Date
Quality/Regulatory
