Quality Assurance Manager

BWXT Medical Ltd. is a trusted source for the development and manufacture of nuclear medicine for biotechnology, life sciences, pharmaceutical companies and academia partners. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 300 highly-skilled people in Kanata and Vancouver, British Columbia. 

Welcome to BWXT
We believe in empowering our employees and cultivating a dynamic workplace that fosters growth and collaboration. Whether you’re an experienced professional or just starting your career, you'll find opportunities to challenge yourself, learn from seasoned experts, and contribute to nuclear innovation. We required a diverse range of skills to support our work in the markets that drive our business and welcome candidates from all backgrounds and life stages who are passionate about making a difference.

Position Overview:

The Radiopharmaceutical Quality Assurance ("QA") Manager is responsible for overseeing the quality assurance process within BWXT Medical. The QA Manager leads a team of quality control professionals and are responsible for ensuring that products or services meet the established quality standards. The QA Manager is accountable for forecasting, planning, resourcing, scheduling and execution of quality control testing to meet commercial and customer needs. The QA Manager is responsible for the development and implementation of quality control procedures, for monitoring the performance of the QC team, and collaborating with other departments to identify and resolve quality issues. The QA Manager is the decision authority on releasing finished pharmaceuticals or medical devices for use in patients. They may also conduct audits and inspections to ensure compliance with regulatory requirements and industry standards. Strong leadership, analytical, and problem-solving skills are essential for this role. 

Location:

On-site in Kanata, Ontario

Your Day to Day as a Quality Manager: 

• Responsible for the testing and release of products, ensuring that QC work is performed in accordance with priorities
• Reviews and recommend changes to production processes to improbe peoduct quality. Ensures that all modifications are approved, validated and documented as required by GMP's 
• Audits and reviews procedures to ensure SOP's and STM's are followed as written and that witnesses are obtained as required throughout the batch doucmentation. Updates documentation to reflect approved changes in work practises and reviews and approves operations documents as required. 
• Assists in the development of new products
• Ensures that traceability is maintained over all QC processes in accordance with GMP's. Initias corrective action to ensure compliance
• Manages the cost center expenses. Prepares and administers the cost center plan. Ensures that applied hours reflects actual level of staff productivity. Forecasts and justifies any deviations from plan. Responsibile for keeping projects and capital expenditures on target
• Initiates improvement projects that will increase product value, quality improvement, and employee safety
• Develops and maintains a system for inspecting and controlling incoming raw materials and ensures compliance of released materials with specifications 
• Responsbile for resolution of customer complaints related to product quality in the incumbents area of responsibility and ensure that QC analytical abilities meet the needs of our customers
• Ensure Equipment is maintained in accordance with preventative maintenance plans, calibration requirements and GMP's 
• Responsible for the implementation of departmental training programs and evaluation of that training program's effectiveness 
• Implement quality improvement, cost/reduction programs to improve productivity, reduce inventory, and facilitate feedback into production. Initiates, implements, and oversees product modifications to meet market requirements 
• Performs as a techincal resources within the scope of the emergency response plan. May Perform as an alternate emergency response manager
• May act as a subsitute for the Director, QA
• Supports the Regulatory Affairs team with providing answers to Regulatory Questions and/or providing data and analysis for submission
• Participate in the development of strategic objectives. Leads the QC team through these accoplishments 
• Responsibile to ensure the Quality Control fuction is in complaince with Good Manufacturing Practices (GMP's) and other regulatory and customer requirements
• Responsible for the final product release. Must ensure that final product meets specifications, both internal and external, and that product is in compliance with GMP's. If prodcut is not found to be complaint, the QC Manager is responsbile to reject manufactured product or halt a manufacturing event. 
• Responsible for timely release of raw materials, kaing decisions regarding non-conforming materials, and liaison with appropriate deparments 
• Plans, organizes and trouble shoots quality control functions and promotes team effort to optimize quality and productivity 
• Responsible for preparation of financial plans and maintenance of budget 
• Provides techincal guidance as required to new prodcut and process development, participate as a memeber of product or process development teams

Team Management:

• Responsible for the hiring, supervision and development of a group of Quality Control technicians performing tests on materials, components and finished products. Establishes performance and training objectives, taking corrective action as required.
• Responsible for hiring and training of QC staff and performing employee evaluation.
• Manages and provide leadership, coaching and development to the Quality Control Technicians responsible for microbiological and/or chemical analyses of all BWXT Medical Products.

Required Qualifications: 

• An undergraduate BSc degree in chemistry or microbiology with 5+ years relevant experience, or College diploma may be considered when combined with 7+ years relevant experience. The Radiopharmaceutical Quality Assurance Manager must have at least one university level course in Microbiology, or other industry specific aseptic process training. 
• Must have proven leadership skills. Ideally, the incumbent will have had previous experience in pharmaceutical, device or health care products.
• Must have strong interpersonal qualities of leadership and initiative and set appropriate standards for performance to ensure staff is motivated to meet objectives 
• Must be able to plan, organize and direct quality control activities effectively 
• Must have an understanding of Chemistry and or Microbiology and a good working knowledge of radiation physics 
• The Radiopharmaceutical Quality Assurance Manager must have experience working with GMP's. Sterile manufacturing would be an asset
• Must be able to analyze situations and make decisions often with minimal information and little time for optimization or corrective action. Must be resourceful, creative and posses superior problem solving skills
• Proven reacord of making difficult independent and sound decisions under pressure
• Knowledge of working with a union and within a collective agreement is considered an asset. 

WHAT WE CAN OFFER YOU: Ensuring the well-being of our employees is our priority and we offer comprehensive and competitive benefits for our employees and their families.

• Comprehensive Health Benefits – Including health, dental, vision, and disability coverage to keep you feeling your best.
• Secure Your Future – Defined Contribution Pension Plan and an optional Company-matched retirement savings plans (RRSP/TFSA/EPSP)
• Work-Life Balance – Flexible hybrid schedules and compressed workweek option available
• Help Grow Our Team – Earn generous referral bonuses with our two-tiered
• Employee Referral Program ($1,500 and $3,000!).
• Invest in Your Education – Up to $5,250 USD per year through our Educational Refund Plan.
• Professional Development – Gain access to training, certifications, and growth opportunities to advance your career.
• Your Wellness Matters – Enjoy gym membership discounts and access to mental health support programs.
• A Welcoming Workplace – Join a diverse, inclusive, and supportive culture that celebrates you.
• Fun & Connection – Engage in team-building activities organized by our Social Committee.Ready to grow with us?

Apply now and let’s build something amazing together!  

At BWXT, we are committed to a fair, transparent, and inclusive hiring process.

As part of our recruitment practices, we use artificial intelligence (AI) tools to assist with screening and evaluating applicants. These tools support our efforts to make consistent and equitable hiring decisions.

The base salary range for this position in Ontario (CA-ON) at the start of employment is expected to be between $$108,000 and $$158,000 per year. However, the base salary offered is based on local job market factors and may vary further depending on factors specific to the selected job candidate, such as job-related knowledge, skills, experience, and other objective business considerations. Subject to these considerations, the total compensation package for this position may also include other elements, such as an annual cash incentive in addition to a full range of medical, retirement, and/or other benefits. Details of participation in these benefit plans will be provided at such time the selected job candidate receives an offer of employment.

Learn more about how BWXT employs nuclear technology to solve some of the world’s most important problems. BWXT’s capabilities video showcases our innovation in commercial nuclear power, addressing climate change, as well as our advanced nuclear medicine products treating patients around the world. We are People Strong. Innovation Driven.

BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives and provides equal opportunity in employment for all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, a conviction for which a pardon has been granted or a record suspended or any other category protected by federal law. BWXT Medical Ltd. is committed to fostering an accessible, fair, and inclusive environment where all employees are able to access goods while being respected and supported. If you require accommodations during the application or interview process, please advise us as soon as possible so appropriate arrangements can be made. If you require information in a format that is accessible to you, please contact Human Resources.