Site Quality Events Lead

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.

BIOVECTRA joined Agilent in 2024 and is part of Agilent’s Advanced Manufacturing Partnerships Division (AMPD), which also contains Agilent’s Nucleic Acid Solutions Division. With BIOVECTRA, Agilent aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence. Within AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advanced manufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics.

The Technical Investigations Lead leads the site investigation program for manufacturing, environmental, contamination, and process-related events.

The role ensures timely, compliant, scientifically sound investigations and drives the effectiveness of CAPAs that impact Windsor biologics operations.

Key Responsibilities:

• Provide daily leadership to site investigators supporting Manufacturing, QC, and Engineering

• Ensure investigations meet CGMP, ICH, Health Canada, and corporate standards

• Oversee and improve deviation, CAPA, and change-control lifecycle management

• Establish investigation workflow, team goals, and RCA capability across the site

• Represent the Windsor site during internal and external audits for deviations and CAPAs

• Trend site nonconformance to identify systemic issues and improvement opportunities

• Drive consistency, training, and technical coaching for investigators and SMEs

• Partner cross-functionally to eliminate recurrence of contamination and process failures

Qualifications

Required:

• Bachelor’s degree in Science or Engineering

• 6+ years of experience in GMP manufacturing environment

Desired:

• Advance degree in applicable field of study

• Experience in methodology, quality, engineering, or investigations

• Expertise in RCA, CAPA effectiveness, and deviation management

• Strong communication, facilitation, teamwork, presentation and technical writing skills

• Ability to lead cross-functional teams and manage competing priorities

• Experience supporting regulatory inspections (FDA, Health Canada, EMA)

• Knowledge of biologics, upstream/downstream operations, utilities, and contamination control preferred

Additional Details

This job has a full time weekly schedule.The full-time equivalent pay range for this position is $81, - $126, 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: 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:

Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory