Manager Quality Assurance Biologics

3 weeks ago

Windsor, Canada BioVectra Inc. Full time

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**.
- 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.
- 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.

- 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.**

**Closing April 24, 2023

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