Assistant Vice President, Quality/Regulatory (NS)

PEI BioAlliance; Windsor; On-site; CAD 80,000 - 130,000; Full time

Job summary

Join a forward-thinking organization as the Assistant Vice President of Quality/Regulatory. This role offers a unique opportunity to lead a dynamic team in a state-of-the-art facility dedicated to improving patient care through advanced manufacturing. You will oversee compliance with global standards, manage regulatory interactions, and guide products from early phases to commercial production. With a commitment to diversity and an inclusive environment, this position is perfect for those passionate about making a significant impact in the biotech industry. If you're ready to embrace a leadership role that fosters innovation and operational excellence, apply now!

Qualifications

• 8+ years of management experience in FDA-regulated industry.
• Technical knowledge in biologics testing and aseptic manufacturing.

Responsibilities

• Establish quality and regulatory strategies for compliance.
• Lead a team of over 50 quality professionals.

Skills

Management Experience

GMP Experience

Regulatory Interface

Biologics Testing

Aseptic Manufacturing

Lean Six Sigma

Communication Skills

Change Management

Education

Master’s Degree in Biology

10+ Years of Relevant Experience

Tools

Microsoft Office

Job description

Windsor, NS, Canada

Job Description

Posted Thursday, May 1, 2025 at 3:00 AM | Expires Wednesday, June 18, 2025 at 2:59 AM

We are excited to announce the formation of the Advanced Manufacturing Partnerships Division (AMPD), which combines the Nucleic Acid Solutions Division (NASD) and BIOVECTRA Inc., a part of Agilent. This division aims to align advanced manufacturing capabilities, expertise, and resources to foster innovation and operational excellence.

As part of AMPD, you will work with cutting-edge technologies and collaborate with dedicated professionals committed to industry impact. Join us in revolutionizing advanced manufacturing and contributing to the success of NASD and BIOVECTRA.

At BIOVECTRA, we are passionate about improving patient care by manufacturing better therapeutics. As a contract drug manufacturing organization (CDMO), we partner with leading pharmaceutical and biotech companies worldwide. Our Windsor, Nova Scotia facility produces assays for testing biologics and small molecule drug substances, biological assay development, microbial fermentation, aseptic manufacturing, and environmental monitoring/microbiology. Our team combines a global reach with a strong sense of community, fostering teamwork, respect, professionalism, and quality. We embrace diversity and strive to maintain an inclusive environment.

We are currently seeking an Assistant Vice President, Quality/Regulatory based in Windsor, Nova Scotia, responsible for all quality and regulatory decisions, outcomes, and oversight. Reporting directly to the AVP II of Quality and Regulatory of AMPD, the Site Quality Head will lead a team of over 50 quality professionals in a dynamic environment supporting manufacturing, testing, inspections, and compliance with regulations, focusing on patient and product safety.

ESSENTIAL FUNCTIONS:

• Establish quality and regulatory strategies, support business objectives, and oversee compliance with global standards.
• Guide products from early phases through commercial production, overseeing quality assurance, control, systems, operations, engineering, compliance, audits, training, and improvements.
• Serve as the main delegate and contact for US and international regulatory authorities, representing QA internally and externally, including Health Canada and FDA.
• Manage client interactions, including visits, audits, and responses related to quality and regulatory matters. Presence at the Windsor facility is required.
• Handle budgeting, staffing, performance, and compensation; participate in leadership teams.
• Lead the site through integration and transformation, demonstrating strong leadership to build relationships and manage change.

KEY REQUIREMENTS:

• 8+ years management experience leading managers, including hiring, performance management, and development.
• 8+ years in an FDA-regulated industry, with GMP experience and regulatory interface.
• Technical knowledge in biologics testing, microbial fermentation, biological labs, and aseptic manufacturing.
• Experience with regulatory inspections, registrations, submissions, and agency relationships.
• Expertise in cGMP regulations, deviation handling, validation, QC, and product release.
• Ability to interpret analytical data and apply scientific principles.
• Lean Six Sigma training or certification is preferred.
• Strong leadership, change management, and cross-cultural team skills.
• Proficiency with computer applications, including Microsoft Office.
• Excellent communication skills, with the ability to manage relations and projects.
• Willingness to travel less than 20% of the time.

EDUCATION:

• Master’s degree in biology or related field, or 10+ years of relevant experience, or equivalent education and experience. GMP production experience is required.

We are committed to diversity and inclusion, providing accommodations for individuals with disabilities. Qualified applicants will be considered without regard to age, race, religion, ethnicity, gender, disability, citizenship, marital status, or sexual orientation. If you are passionate about leading in this role, apply now. Only shortlisted candidates will be contacted.