Job Description

Req #1372

Thursday, October 19, 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 Senior Quality Assurance (Incidents/CAPA). This is a permanent, full-time position located in Charlottetown, PEI.

The candidate will be responsible for:

• Managing the Incident Investigations Program, including assessing, improving, and maintaining to ensure compliance with current industry standard practices and compliance requirements.
• Demonstrating the ability to understand complex quality issues and drive scientifically sound and compliant resolutions.
• Ensuring continuous improvement, harmonizing quality systems and teams, and strengthening quality awareness.
• Providing quality oversight, and actively participating, in investigations related to quality incidents including deviations, customer complaints, out of specification investigations, and supplier incidents, with aim to determine root and probable causes.
• Assessing trends and introducing remediation e.g. use of risk assessment, root cause analysis, risk analysis tools and appropriate CAPA implementation.
• Quality Management of the CAPA program including approval of action plans and assessment of effectiveness.
• Developing KPI goals to drive improvements.
• Participating in the development of Electronic Quality Management Systems (EQMS) programs specific to incidents, investigations, and CAPA.
• Authorizing and training on documents required to ensure that BioVectra is in compliance with the current regulations in regards to API\'s, medical devices and finished drug products.
• Participating in internal and external audits as a subject matter expert for Investigations and CAPA.
• Keeping current with regulations, providing regulatory, compliance advice, consultation and support to all BioVectra departments.
• Monitoring and enforcement of GMP requirements during day to day operations for all departments within the company.
• Participation in the budgetary process for the Quality Unit.

The successful candidate for this position should have:

• Bachelor degree in a scientific discipline.
• Five years of experience working in pharmaceutical, biotech, or similar industry.
• Experience in the design and implementation of quality management systems and continuous improvement.
• Knowledge of cGMPs, FDA and Health Canada pharmaceutical regulations for API\xe2\x80\x99s.
• Experience with Regulatory Agencies.

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: November 3, 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