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Manager, Quality Assurance

Location
Burnaby, BC
Details
Full Time
7 days ago

POSITION

Manager, Quality Assurance


ABOUT THE COMPANY

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 Canadian site Director and to the GM-Corporate Quality in Hong Kong, the incumbent will be responsible for the overall creation and implementation and maintenance of an effective quality management system (QMS) at the Canadian site. The QMS must be designed to meet the strictest GMP requirements which apply to manufacturing of sterile injectable pharmaceutical products. The incumbent will also provide guidance on validation strategy and assures that validation is executed per global regulatory guidance and standards. 

 
KEY RESPONSIBILITIES

  • Provide supervision and general direction to the QA team
  • Establish & maintain all aspects of the pharmaceutical quality system, including but not limited to, personnel training, document control, deviation, OOS, CAPA, auditing, change control, quality risk management, supplier management and product quality review
  • Ensure production equipment and QC instruments are qualified for use
  • Ensure manufacturing process, cleaning procedures and QC testing procedures are validated
  • Review and approve all QMS documentations
  • Ensure all necessary documentations (i.e. Quality Policy, Site Master File, Validation Master Plan, Specification and SOPs) for manufacturing, quality control and release of the API and finished products are in place
  • Review batch records of finished products to ensure every batch is compliant to cGMP requirement, marketing authorizations and any other regulations relevant to drug products
  • Conduct inspections or arrange for independent inspections to assure the SOP is implemented as stated
  • Conduct supplier evaluations and on-site audits if necessary, including but not limited to, suppliers of critical biological starting materials, critical packaging material, or outsourced service providers
  • Maintain up-to-date knowledge of regulatory requirements for SOP upgrade and GMP compliance
  • Develop annual operating budget for department and manage expenditures
  • Provide direction, mentoring, coaching and development towards personal growth to QA team members
  • Work closely with other departments in supporting product launch and distribution
  • Perform other tasks as required.


KNOWLEDGE, SKILLS AND ABILITIES

  • MSc Degree in life sciences or engineering discipline
  • 7+ years of relevant work experience in pharmaceutical, Biotechnology manufacturing industry
  • 3+ years of supervisory experience
  • Experience in aseptic processing and sterile product manufacturing
  • Knowledge of other quality systems/quality assurance principles
  • Excellent interpersonal skills and solid leadership skills
  • Ability to be innovative and provide creative solutions
  • Have strong business acumen and take pride and ownership of quality work.


WHY JOIN NBI-CA?

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!


HOW TO APPLY

Please apply through our online application system, found at:

https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=d2be7702-ad25-4a0b-8f2e-a98f72b7158b&ccId=19000101_000001&jobId=174298&source=CC3&lang=en_CA

Category
Biotechnology