Job Description

Req #1161

Thursday, March 9, 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 opening for a Manager Quality (QA/QC). This is a permanent, full-time position located in Charlottetown, PEI.

The candidate will be responsible for:

• 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.
• 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 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. Interested candidates are asked to apply by choosing the \xe2\x80\x9cApply Now\xe2\x80\x9d button

Closing Date: March 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