New Beta innovation canada Ltd. Hiring for Assistant Manager, Quality Assurance (QMS) at Burnaby, BC Full Time

New Beta Innovation Canada Limited (NBI-CA) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ischemic and hypoxic conditions.

Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.

POSITION OVERVIEW

Reporting to the Senior Manager, Quality Assurance (Compliance), the incumbent will be responsible for managing QMS activities including change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits.

KEY RESPONSIBILITIES

Act as SME for QMS activities, i.e. change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits and responsible for making quality decision related to these topics

Lead the regulatory inspection preparation and see through the inspections from QMS perspective

Develop and implement QMS SOPs/policies including but not limited to quality policies, quality manual, change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits

Review and approve all GMP documentation including but not limited to SOPs, change control, CAPA, deviation, risk assessment, supplier qualification, internal and external audits, batch records, validation/ qualification documents, sample/ test records

Collaborate and work closely with all department to improve quality culture

Lead vendor qualification program and ensure compliance with regulatory requirements

Review and approve material assessments, material qualification documentation and specifications of production raw material, excipient and disposables

Develop and coordinate internal and external audits plans when necessary, and contribute to drafting the audit plan and report

Support implementation of the process module of the Master Control project from the end user’s perspective, ensuring successful project deliverables meet the project schedule

Support in equipment, facility, utility qualification, process, cleaning, analytical and microbial method validation activities

Lead, coach and develop QA team members

Perform other duties as required

KNOWLEDGE, SKILLS AND ABILITIES

Degree in Life Sciences or relevant field

Minimum 6 years of experience in pharmaceutical or biopharmaceutical industry with minimum 1 year supervisory experience

Strong quality mindset and quality decision making ability with holistic approach

In depth knowledge of quality systems/quality assurance principles

Strong quality mindset and quality decision making ability

Knowledge and experience with aseptic processing is an advantage

Excellent interpersonal skills and solid leadership skills

WHY JOIN NBI?

The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it’s hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees’ growth with the company.

If you are interested in joining our team, we encourage you to APPLY today!