Associate Vice President, Quality
- Windsor, NS
- Permanent
- Full-time
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.ESSENTIAL FUNCTIONS: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.QualificationsKEY 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