Job Description

Req #866

Wednesday, August 3, 2022

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

BIOVECTRA Inc. has an opening for a Director of Quality Operations, Biologics. This is a permanent, full-time position located in Windsor, NS with travel to Charlottetown, PEI.

The candidate will be responsible for:

• Overall Quality Management of the BIOVECTRA's Specialty Biologics Facility located in Charlottetown, PEI & Biologics Facility located in Windsor, NS primarily responsible for the manufacture of plasmid DNA, mRNA, recombinant proteins, and Sterile Fill Finish.
• Managing a team of approximately 35-40 quality professionals, with direct reports in the areas of Quality Assurance, Quality Control and Quality Projects.
• Overseeing the design, installation and qualification of the facility, equipment, utilities and laboratories from a quality perspective, working with internal SMEs
• Establishing a quality program related to Nucleic Acids, mRNA and fill finish programs at the site.
• Working with internal partners to identify and on-board new projects to the site
• Identifying and setting departmental goals for the Quality Department.
• Assigning and scheduling work to meet departmental goals including product release targets, department and site KPIs and client relationship requirements.
• Oversee introduction of new products, trouble shooting of existing methods and transfer and implementation of new analytical methods into the site to ensure site is meeting all cGMP regulatory requirements.
• Oversee QA functions at the site including but not limited to lab / manufacturing data review, QA inspection requirements, incident management (Deviations/CAPAs/Lab Incidents).
• Oversee QC functions at the site include chemistry and microbiological testing of raw materials, environmental samples, in-process samples, stability samples and final product.
• Ensuring that the site, including quality control laboratories, manufacturing and warehouses, are prepared at all times for customer audits, and regulatory inspections.
• Identifying and implementing policies to improve professional capabilities and efficiencies of the Quality Department and site personnel through training, professional development and mentoring.
• Supervising Manager, Quality Projects who oversees introduction of new products, trouble shooting of existing methods and transfer and implementation of new analytical methods into the site to ensure site is meeting all cGMP regulatory requirements.
• Supervising Manager, Quality Assurance who oversees all QA functions at the site including but not limited to lab manufacturing data review, QA inspection requirements, incident management.
• Supervising QC Superintendents who oversee all QC functions at the site include chemistry and microbiological testing of raw materials, environmental samples, in-process samples, stability samples and final product.
• Coordinating, prioritizing and managing multiple projects, including the work of various subordinates and/or team members.
• Reviewing and approving QC procedures, Method Validation protocols and reports, related SOPs and other QA controlled documentation.
• Overseeing of project and departmental budgets, reviewing and approving of material orders.
• Developing, utilizing and reporting metrics for the performance of the Quality Unit in the areas of efficiency and quality in order to properly identify and respond to trends and areas for improvement, and to set departmental goals.
• Providing regular progress updates and reports, and identifying additional resource requirements.
• Administering HR policy with respect to subordinates including developing performance standards, hiring, conducting performance reviews and assisting with managing the continued professional and business development of direct reports.
• Managing all LIRs, OOS's department deviations and associated investigations. Ensuring corresponding CAPA's assigned to the QC department completed in a timely manner.

The successful candidate for this position should have:

• B.Sc. degree or equivalent experience in Biochemistry or a closely related discipline for the specific area of group specialization.
• Ten years of relevant industrial experience is required, with focus on Biologics/mRNA and Fill Finish considered an asset.
• Knowledge of current Good Manufacturing Practices is (cGMP) required
• Knowledge of a wide range of technical skills related to the job function.
• Knowledge of ICH, FDA and relevant agency guidelines and requirements.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the "Apply Now" button

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.

Other details

• Pay Type Salary