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Manager, Quality

5 months ago

Charlottetown, 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 opening for a
**Manager Quality (QA/QC). **This is a permanent, full-time position located in
**Charlottetown, PEI.**
- Exercising discretion over hiring, training, evaluation and if need be discipline and dismissal of staff (from QA/QC teams).
- Making decisions on the allocation of resources including personnel and instrumentation to ensure that sales and payment deadlines are met and that the lab’s internal clients experience a strong and consistent service level.
- Providing information on departmental activities to internal clients, and/or routing requests to ensure that information is provided promptly when needed.
- Data auditing and review and providing final signoff on approval/rejection of tested materials where needed.
- Taking a lead role in documenting and designing laboratory investigations, and ensuring resources are allocated to allow their timely resolution.
- Writing, reviewing and approving Quality Control deviations.
- Ensuring follow up actions arising from quality system events including but not limited to audits, CAPAs, deviations and OOS investigations are completed and documented on-time.
- Periodically reviewing higher-level departmental SOPs and making necessary revisions.
- Seeking continuous refinement and improvement in all areas of quality, compliance, output and efficiency, and ensuring standards are maintained.
- Taking a lead role in maintaining the highest standards of safety in all QC laboratories.
- Adhering to BIOVECTRA’s Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
- 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.
- 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 degree in Chemistry or Biochemistry
- Five years of relevant work experience in a GMP environment with focus on biologics.
- Knowledge of instrumental and wet chemical techniques.
- Knowledge of regulatory guidelines as found in ICH, CFR, USP, _etc. _
- Supervisory, organization and management experience.
- Experience in the design and implementation of quality management systems and continuous improvement.

**Entry: $79,000 Salary***

**BIOVECTRA offers a competitive salary and benefit package.**

**Closing Date: March 24, 2023