Director, Quality Operations Biologics [Biovectra Inc. ]

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

• Adhering to BIOVECTRA's Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
• Reviewing and authoring reports and protocols.
• Providing regular progress updates and reports and identifying additional resource requirements.
• Designing and reviewing investigational plans regarding deviations, CAPAs and laboratory investigations.
• Coordinating, prioritizing, and managing multiple projects, including the work of various subordinates and/or team members.
• 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.
• Identifying and implementing initiatives to improve quality and efficiency in the quality group.
• Overseeing of project and departmental budgets, reviewing, and approving of material orders. Seeking cost savings as appropriate.
• Assigning work and scheduling to meet departmental and product release goals.
• Identifying and implementing policies to improve professional capabilities and efficiencies of the group through training, professional development, and mentoring.
• 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.
• Ensuring that the Quality Unit is always prepared for customer audits, and regulatory inspections.
• Overseeing of Product transfer into the Business Unit including manufacturing and testing processes to ensure the Product meets the cGMP requirements for the project.
• Reviewing and approving QC procedures, Method Validation protocols and reports, related SOPs and other QA controlled documentation.
• Additional duties assigned, based on business needs and the department supervisor's request.
• Directing Quality Control/Quality Assurance/Quality Projects teams.
• Identifying and setting departmental goals for the Quality Unit.

The Successful Candidate For This Position Should Have

• Knowledge of fill finish/mRNA an asset
• Knowledge of varied technical skills related to job function.
• Ten years of relevant industrial experience is required.
• Knowledge of current Good Manufacturing Practices is (cGMP) required.
• Knowledge of ICH, FDA and relevant agency guidelines and requirements.
• Bachelor of Science or equivalent experience in Analytical Chemistry, Biochemistry, or a related discipline.

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