Site Quality Events Lead

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

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