Manager, Quality Assurance

BIOVECTRA has an opening for a Manager, Quality Assurance. This is a 16 Month Term, full-time position located in Charlottetown, Prince Edward Island.

The candidate will be responsible for:

• 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.
• Allocating resources and coordinating with stakeholders across the Quality Unit and the company to ensure that batch record and data review due dates are set appropriately and are met.
• Managing and approving change controls, deviation investigations and lab incidents pertaining to Operations.
• Demonstrating the ability to understand complex quality issues and drive scientifically sound and compliant resolutions.
• Managing and trending analytical, production and stability data to observe trends and resolve issues.
• Overseeing regulatory actions and recalls related to the product.
• Preparing, reviewing, and approving of controlled documents.
• Overseeing and participating in the preparation of annual product reviews.
• Assessing gaps in the Quality System and its application, and introducing remediation e.g., use of risk assessment, root cause analysis, risk analysis tools and appropriate CAPA implementation.
• Ensuring continuous improvement, harmonizing QA and Compliance systems, and strengthening quality awareness.
• Providing quality oversight and guidance ensuring required Quality and compliance standards are met.
• Building and maintaining close communication with clients on quality items including change management, investigations, master documents, CAPA and annual product review
• Participating in audit readiness programs and in client and regulatory inspections of BIOVECTRA facilities.

 The successful candidate for this position should have:

• Post-Secondary education.
• Bachelor’s degree in a scientific is an asset.
• Five years of experience in Quality Assurance in pharmaceutical and/or biotech.
• Experience in the design and implementation of quality management systems and continuous improvement.
• Knowledge of cGMP, FDA, and Health Canada pharmaceutical regulations for API’s.
• Experience with Regulatory Agencies.
• Experience working in a pharmaceutical laboratory setting.
• Ability to work independently with minimal supervision.
• High attention to detail, excellent decision making and problem-solving skills.
• Excellent interpersonal and team skills.
• Proficient communicator, both written and oral.
• Excellent leadership skills.
• Excellent organizational skills.
• Ability to effectively interpret and analyze data.

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

Starting annual salary is based on experience $75,000

Closing October 25, 2024