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.
Reporting to the Manager/Senior Manager, Quality Assurance, 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.
- 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 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 documentation including but not limited to SOPs, change control, CAPA, deviation, risk assessment, supplier qualification, internal and external audits
- Review GMP documentations including but not limited to batch records, validation/ qualification documents, sample/ test records
- Collaborate and work closely with all department to improve quality culture
- 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
- Provide support in performing line clearance and QA oversight of production and other critical areas
- 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 5 years of experience in pharmaceutical or biopharmaceutical industry with minimum 1 year supervisory experience
- Strong quality mindset and holistic approach to guarantee product quality and patient safety under company QMS
- In-depth understanding of bulk manufacturing, aseptic filling process and biologic product characteristics and familiarity with in-process-control strategy and final product testing methods
- Experience dealing with inspectors and auditors from various regulatory bodies
- Excellent interpersonal skills, ability to work independently and in a team environment
- Working efficiently with the ability to be innovative and identify creative solutions
- High proficiency in MS Word/Excel and good writing skills
- Strong sense of pride in ownership of, and quality of work
- Attention to detail
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!