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New Beta Innovation Canada Limited

Senior Manager, Quality Control

Location
Burnaby, BC
Details
Full Time
3 days ago

ABOUT THE COMPANY

New Beta Innovation Canada Limited (NBI) 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 liaison with Head Office, the incumbent will lead the Canadian site Quality Control (QC) team and will be responsible for ensuring the integrity of quality as it relates to process and product.

The incumbent will need to be flexible with their work hours and schedule, and may be required to perform shiftwork to fulfil manufacturing requirements. Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.

KEY RESPONSIBILITIES

  • Plan, organize, and monitor QC activities in accordance with cGMP
  • Approve or reject starting materials, packaging materials, intermediates, bulk and finished product in relation with their specifications
  • Ensure tests for materials, intermediate, bulk and finished product are done according to validated or qualified compendial methods and the associated records evaluated
  • Approve and implement sampling instructions, specifications, test methods and other quality control procedures
  • Ensure company’s QMS is effectively implemented and followed within QC section
  • Ensure timely and effective communication of potential risks, quality or compliance issues to the appropriate personnel (eg. Qualified Person (QP), site senior management, or Head Office)
  • Facilitate effective transfer of testing methods from corporate to site and adopt their use for intermediates, bulk and finished product at site
  • Ensure alignment of QC systems, policies and practices with those from Head Office
  • Ensure quality control practices comply with regulatory commitments in NBI dossiers per CMC section of marketing applications
  • Approve and monitor any Contract Laboratory analysis
  • Ensure QC facilities and equipment in accordance with cGMP standards and requirements
  • Ensure that appropriate calibration, qualification of QC equipment and validations (including test method validations) are done in accordance to cGMP standards
  • Oversee the control of the reference and/or retention samples of materials and products, and ensure the correct labelling of containers of materials and products
  • Ensure that all required initial and continued training of the QC Section personnel is carried out
  • Establish and maintain QC programs including Environmental Monitoring, in-progress control, stability testing for finished product 
  • Provide expertise and technical leadership managing deviation, out-of-specifications (OOS)/out-of-trend (OOT) investigations, CAPA
  • Participate in regulatory inspections and provide responses to QC related matters in a timely manner
  • Perform other duties as required

KNOWLEDGE, SKILLS AND ABILITIES

  • Degree or above in pharmaceutical or equivalent life sciences discipline is a must
  • Minimum 10 years relevant work experience with 3+ years of supervisory experience in pharmaceutical or biological manufacturing industry. Knowledge with aseptic processing is preferred 
  • Good working knowledge of GMP and regulatory requirements for products in major markets (such as FDA, EMA, HC, TGA)
  • Excellent interpersonal skills, ability to work independently and in a team environment
  • Work efficiently with the ability to innovate and identify creative solutions
  • High proficiency in MS Word and good writing skills
  • Strong sense of pride in ownership and quality of work

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!

Category
Biotechnology