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 a Manager, Quality Operations. This is a permanent, full-time position located in Charlottetown, PEI.
The candidate will be responsible for:
- Performing batch record reviews and making product disposition decisions based on quality risk assessment principles.
- Understanding complex quality issues to manage and approve all change controls, deviation investigations, and Lab Incidents.
- Managing analytical, production, and stability data to observe trends and resolve issues.
- Overseeing environmental monitoring programs, regulatory actions / recalls related to the product, and the preparation, review and approval of controlled documents.
- Preparing annual product reviews.
- Assessing gaps in the Quality System and its application, and introducing remediation through risk assessment, root cause analysis, risk analysis tools, and appropriate CAPA implementation.
- Harmonizing QA and Compliance systems to ensure continuous improvement and to strengthen quality awareness.
- Providing quality oversight and guidance to ensure required Quality and compliance standards are met.
- Building and maintaining close communication with the client on quality items, including but not limited to: Change Management, Investigations, Master documents, CAPA, and Annual Product Reviews.
- The ongoing audit readiness program for the 29 McCarville manufacturing site and ensuring that the Quality System is managed and maintained.
- Participating in client and regulatory inspections of the 29 McCarville facility.
- Travel as required.
The successful candidate for this position should have:
- Bachelor of Science.
- 5 years’ experience in Quality Assurance in either the pharmaceutical or biotech industry.
- Minimum 2 years’ of supervisory experience, and proven leadership skills.
- Experience in the design and implementation of quality management systems, and working with Regulatory Agencies.
- Knowledge of current GMP, FDA, and Health Canada pharmaceutical regulations for APIs.
- Ability to analyze and interpret data.
- Excellent written and oral communication skills, attention to detail, and decision making ability.