Assistant Vice President, Quality/Regulatory

The posting

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 Charlottetown facility operates diverse manufacturing capabilities covering small and large molecules, sterile operations and potent compound capabilities, with a focus on patients and product safety which requires agility in application of regulations. 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 an Assistant Vice President, Quality/Regulatory based at our Charlottetown, PEI, Canada location reporting directly to the Associate Vice President (AVP II) of Quality and Regulatory, AMPD of Agilent Technologies. This leader is accountable for all quality and regulatory oversight, decisions and outcomes. The Site Quality Head will lead an organization of >120 dedicated Quality staff members in a highly dynamic environment supporting manufacturing, laboratory testing, client and regulatory inspections, ensuring all products are following the latest guidelines and regulations.     ESSENTIAL FUNCTIONS:  

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.

  KEY POSITION REQUIREMENTS:

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 < 20% of time.

EDUCATION:

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.

  The full-time equivalent pay range for this position is $157,850.00 - $246,641.00/yr CAD   Individual accommodations due to a disability are available upon request for candidates taking part in all aspects of the selection process. All qualified applicants will receive consideration for employment without regard to age, race, religion, ethnicity, gender, disability, citizenship status, marital status, actual or perceived sexual orientation. BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills. We value diversity and recognize that experience comes in many forms and skills are transferable. Please view this description as a general overview, but not a mandatory comprehensive list. If you feel passionate about our efforts and believe that you have the skills to contribute and lead in this role, apply!   We thank all interested parties; however, only those applicants considered for an interview will be contacted.