JOB DESCRIPTION

We are excited to announce the formation of the Advanced Manufacturing Partnerships Division (AMPD), which brings together the Nucleic Acid Solutions Division (NASD) and BIOVECTRA Inc., A part of Agilent. This new division aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence.
As part of AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to making a significant impact in the industry. Join us in our mission to revolutionize advanced manufacturing and contribute 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 is a leading producer of assays utilized for the testing of biologics and small molecule drug substances and drug products, biological assay development and testing, microbial fermentation, aseptic manufacturing, and environmental monitoring/microbiology. Our team combines a global reach with a strong sense of community, fostering a workplace built on teamwork, respect, professionalism, and quality. We embrace diversity and strive to maintain a welcoming and inclusive environment.
We are currently seeking a Site Quality Head based at our Windsor, Nova Scotia, Canada location who is accountable for all quality and regulatory decisions, outcomes, and oversight. This role will report directly to the Associate Vice President (AVP II) of Quality and Regulatory of the Advanced Manufacturing and Partnership Division (AMPD) of Agilent Technologies. The Site Quality Head will lead an organization of >50 dedicated Quality staff in a highly dynamic environment supporting manufacturing, laboratory testing, client and regulatory inspections, and ensuring all products are following the latest guidance and regulations with a focus on patients and product safety.

KEY POSITION REQUIREMENTS:

• 8+ years working in an FDA regulated industry and experience interfacing with regulatory bodies. Prior experience working in a GMP production environment is required.
• 8+ years management experience leading managers, including hiring/recruiting, performance management and manager development activities.
• Technical knowledge/experience in: Assays utilized for the testing of biologics and small molecule drug substances and drug products; manufacturing of microbial fermentation, biological laboratory management, and sterile and aseptic manufacturing. Ability to communicate these technologies with internal scientists and customers.
• Technical knowledge/experience in the following areas would be an asset: microbial fermentation, aseptic manufacturing, biological assay development and testing, environmental monitoring/microbiology.
• Strong experience with regulatory inspections in a GMP environment, as lead representative is required.
• Experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies.
• Expert knowledge of cGMP regulations and guidance documents pertaining to the production of APIs, drug products and applicable GLP testing.
• Expert knowledge of deviation handling (NCR/CAPA/Deviations), Verification/Validation efforts, Quality Control/ Product Release and associated Quality Reporting.
• Ability to read and interpret analytical data as it pertains to the operations performed.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, and graphs) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
• Lean, Six Sigma training and/or certification.
• Strong leadership skills and ability to motivate and lead teams through change.
• Proven ability to drive cultural change across an organization, working in a cross-functional environment to influence and build consensus among teams.
• Demonstrated track record of results using interpersonal, relationship-building skills required to lead multi-cultural and geographically dispersed teams in a fast-paced, highly matrixed environment.
• Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.
• Skill in communication, written and verbal; will be handling various relations issues and will be confronted with various interactions. Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding the products and processes.
• Skill in managing and sponsoring various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives.
• Travel < 20% of time.

EDUCATION:

• Master’s degree or equivalent in biology or related life sciences field; or more than 10 years related experience and/or training; or equivalent combination of education and experience. Prior experience and/or working in a GMP production environment is required.

• Responsible for ensuring quality, and regulatory strategies are established, providing input to BioVectra’s business strategies, supports projects and business objectives, and oversees the execution of quality and regulatory in accordance with global regulations and standards.
• This position guides products from early phase/pre-toxicology material through potentially commercial finished drug product. Oversees the development, implementation and maintenance of quality activities and regulatory for BioVectra to include Quality Assurance, Quality Control/Testing, Quality Systems, Quality Operations, Quality Engineering, Compliance, Document Control, Internal Audit, Training, and Quality Improvement.
• Serves as the main delegate and direct point of contact for all US and International regulatory authorities representing Quality Assurance in Agilent both internally and externally to including Health Canada, FDA, global regulatory authorities, external customers and third parties.
• Will serve as the direct point of contact for all client facing customer interactions to include visits, audits, and providing responses and materials to customers regarding Quality and Regulatory. This position must be routinely present at the Windsor, Nova Scotia Canada facility.
• Responsible for direct budgeting, headcount management, hiring and administrating performance and compensation. Will serve as a member on the BIOVECTRA business leadership team and will be a member of the AMPD Leadership team.
• This position will be expected to lead the Windsor site team through company integration and transformation, and as such, must have strong leadership capabilities to build close business partner relationships and lead teams through change.