Quality Assurance Manager

2 weeks ago

Charlottetown, Prince Edward Island, Canada BioVectra Inc. Full time
Job Title: Quality Assurance Manager

About the Role:

BioVectra Inc. is a leading bio-science business focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents. We are seeking a highly skilled Quality Assurance Manager to join our team.

Key Responsibilities:

- Provide guidance and oversight to a team of employees, ensuring compliance with workplace rules and regulations.
- Allocate resources and coordinate with stakeholders to ensure batch record and data review due dates are met.
- Manage and approve change controls, deviation investigations, and lab incidents related to Operations.
- Demonstrate the ability to understand complex quality issues and drive scientifically sound and compliant resolutions.
- Manage and trend analytical, production, and stability data to observe trends and resolve issues.
- Oversee regulatory actions and recalls related to the product.
- Prepare, review, and approve controlled documents.
- Oversee and participate in the preparation of annual product reviews.
- Assess gaps in the Quality System and its application, introducing remediation as needed.
- Ensure continuous improvement, harmonizing QA and Compliance systems, and strengthening quality awareness.
- Provide quality oversight and guidance, ensuring required Quality and compliance standards are met.
- Build and maintain close communication with clients on quality items, including change management, investigations, master documents, CAPA, and annual product review.

Requirements:

- Post-Secondary education.
- 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.
- Experience working 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 skills.
- Excellent organizational skills.
- Ability to effectively interpret and analyze data.

About BioVectra Inc.:

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. We offer a competitive salary and benefit package to our employees.

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