Job Description

Req #1306

Tuesday, August 8, 2023

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 the Director, Quality Operations Biologics. This is a permanent, full-time position located in Windsor, NS.

The candidate will be responsible for:

• Identifying and setting departmental goals for the Quality Unit.
• Providing guidance and oversight to a team of employees. Responsible for basic Human Resources services for the team including payroll, review, and approval of vacation requests, providing employee feedback and evaluation where needed, and ensuring employees are in compliance with workplace rules.
• Assigning work and scheduling to meet departmental and product release goals.
• Directing Quality Control/Quality Assurance/Quality Projects teams.
• Overseeing of Product transfer into the Business Unit including manufacturing and testing processes to ensure the Product meets the cGMP requirements for the project.
• Designing and reviewing investigational plans regarding deviations, CAPAs and laboratory investigations.
• Reviewing and authoring reports and protocols.
• Identifying and implementing policies to improve professional capabilities and efficiencies of the group through training, professional development, and mentoring.
• Identifying and implementing initiatives to improve quality and efficiency in the quality group.
• 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. Seeking cost savings as appropriate.
• 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.
• Ensuring that the Quality Unit is always prepared for customer audits, and regulatory inspections.
• Adhering to BIOVECTRA\'s Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
• Additional duties assigned, based on business needs and the department supervisor\'s request.

The successful candidate for this position should have:

• Bachelor of Science or equivalent experience in Analytical Chemistry, Biochemistry, or a related discipline.

• Ten years of relevant industrial experience is required.
• Knowledge of current Good Manufacturing Practices is (cGMP) required.
• Knowledge of varied technical skills related to job function.
• Knowledge of ICH, FDA and relevant agency guidelines and requirements.
• Knowledge of fill finish/mRNA an asset

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the \xe2\x80\x9cApply Now\xe2\x80\x9d 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

BioVectra