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 searching 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

Travel Required: 10% of the Time

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory