Assistant Vice President, Quality/Regulatory

• Responsible for establishing and ensuring the strategic regulatory and quality business needs, provides departmental business strategies and objectives, has direct oversight of the execution of quality/regulatory compliance in accordance with global regulations and standards.
• Leads the Charlottetown PEI site’s quality teams to include Quality Assurance, Quality Control, Quality Systems, Compliance, Internal Audit, Training, Quality Improvement, Regulatory, Product Release, Supplier Quality, Quality Engineering, and Document Control team members.
• Provides exceptional leadership through the company integration, transformation, and acts as a change agent while fostering close business partner relationships.

• Serves as the main delegate and point of contact for all US and International regulatory authorities to including Health Canada, FDA and other global regulatory authorities. This position must be routinely present at the Charlottetown, PEI, Canada facility.
• This position guides products from early phase/pre-toxicology material through potentially commercial finished drug product and ensures that the facility is audit-ready at all times.

• 8+ years working in an FDA regulated industry and experience interfacing with regulatory bodies. Prior experience working in a cGMP production environment is required.
• 8+ years management experience leading managers, including hiring/recruiting, performance management and management development activities.
• Strong experience with regulatory inspections in a cGMP environment, as a 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 as pertaining to the production of APIs, drug products and applicable GLP testing.
• Technical knowledge/experience in: Assays utilized for the testing of biologics and small molecule drug substances and drug products, 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: Sterile filling, mRNA, pDNA, LNP, microbial fermentation, aseptic manufacturing, biological assay development and testing, environmental monitoring/microbiology.
• 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.
• 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.
• Proficient in using computer software and hardware applications, including Microsoft products and the Internet.
• Skilled 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.
• Skilled 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

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

BioVectra