Manager, Quality Assurance

BIOVECTRA
CA - Prince Edward Island - Charlottetown
October 18, 2024
Financial

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 has an opening for a Manager, Quality Assurance. This is a 16 Month Term, full-time position located in Charlottetown, Prince Edward Island.

Responsibilities:

Providing guidance and oversight to a team of employees, including basic Human Resources services such as payroll, vacation requests, and employee feedback.
Allocating resources and coordinating with stakeholders across the Quality Unit to ensure that batch record and data review due dates are set appropriately and met.
Managing and approving change controls, deviation investigations, and lab incidents pertaining to Operations.
Understanding complex quality issues and driving 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 controlled documents.
Overseeing and participating in the preparation of annual product reviews.
Assessing gaps in the Quality System and its application, and introducing remediation measures.
Ensuring continuous improvement and harmonizing QA and Compliance systems.
Providing quality oversight and guidance to meet required Quality and compliance standards.
Building and maintaining communication with clients on quality items.
Participating in audit readiness programs and in client and regulatory inspections of BIOVECTRA facilities.

Qualifications:

Post-Secondary education; a Bachelor's degree in a scientific field is an asset.
Five years of experience in Quality Assurance in pharmaceutical and/or biotech.
Experience in the design and implementation of quality management systems and continuous improvement.
Knowledge of cGMP, FDA, and Health Canada pharmaceutical regulations for APIs.
Experience with Regulatory Agencies and in a pharmaceutical laboratory setting.
Ability to work independently with minimal supervision.
High attention to detail, excellent decision-making and problem-solving skills.
Excellent interpersonal and team skills.
Proficient communicator, both written and oral.
Excellent leadership and organizational skills.
Ability to effectively interpret and analyze data.

BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the '' button.

Starting annual salary is based on experience:
$75,000

Closing date:
October 25, 2024

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, or 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. 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.

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Read the full job description and apply online on the recuiter's web-site

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