Job Description

Req #1191

Tuesday, April 11, 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 immediate opening for a Manager Quality Assurance Biologics. This is a full-time permanent position located in Windsor, NS.

The candidate will be responsible for:

• Managing a team of Quality Assurance specialists, including providing professional development and performance feedback.
• 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.
• 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.
• Five years of experience in Quality Assurance working in pharmaceutical and/or biotech.
• Experience in the design and implementation of quality management systems and continuous improvement.
• Knowledge of cGMPs, FDA and Health Canada pharmaceutical regulations for API\'s.
• Experience with Regulatory Agencies.
• Experience working in a pharmaceutical laboratory setting.

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 below.

Closing April 24, 2023

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