Assistant manager, quality assurance
ABOUT THE COMPANY
New B Innovation Ltd. (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.
Reporting to the QA Manager, the incumbent will perform high standard quality oversight on the QMS system at NBICA to meet strict regulatory requirements for GMP activities for sterile bio-pharmaceutical product manufacturing.
- Create, implement and maintain a growing and integrated QMS that is compliant with GMP requirements from major regulatory bodies such as Health Canada, FDA, EMA and TGA. Examples of QMS systems include but are not limited to deviation reporting, change control system, material and supplier qualification programme, batch record review and approval system, CAPA, training programme, internal and external audit program, material management, product quality review and product recall.
- Provide leadership and oversight to staff that perform duties in support of the creation, implementation, and maintenance of the QMS.
- Act as the site lead auditor for all internal and external audits, and use expertise and experience to develop internal auditors within the team.
- Lead inspection-readiness activities for the site, clarify the scope/standard/purpose/schedule of the inspections internally, lead the preparation of documents/SMEs/escorts for inspection, keep tracking and coordinate the preparation readiness status, host and escort the authority inspections.
- Lead the 3rd Party Quality Management (3PQM) function, review and approve material and supplier qualification documents and Quality Agreements. Oversee the performance of the contract lab, review and approve 3rd party event management reports, for example deviation, change control, CAPA and OOS.
- Act as a GMP document reviewer and approver as required for a variety of documents including, but not limited to: SOPs, policies, change controls, material assessments and qualification, supplier qualification, deviations and CAPA.
- Research, develop, and deliver personnel training in specific GMP topics.
- Work closely with QA validation in a supportive role.
- Work closely with QC, Engineering & Maintenance, Production, Regulatory Affairs, and Finance/Logistics departments to achieve deliverables.
- Develop and recommend measures and activities which improve productivity, effectiveness or efficiency of the department.
- Provide training, coaching and mentoring to more junior members of the team.
- Participate in planning of department objectives and oversees team work efforts to meet goals, project timelines and deliverables.
- Develop and sustain a collaborative, respectful team environment.
- Ensure team members are aware of job hazards and work with safety in mind at all times.
- Perform other related tasks as needed.
KNOWLEDGE, SKILLS AND ABILITIES
- Degree in life sciences or equivalent combination of education and experience
- 5 - 7 years relevant work experience in pharmaceutical or biologics manufacturing industry with 2 years’ experience supervising a team
- Certified Quality Auditor certificate (CQA) or equivalent certificate is essential
- Knowledge and experience with aseptic processing is desirable
- In depth knowledge of GMP and QMS principles
- Excellent interpersonal skills, ability to work independently as well as provide technical guidance and oversight on QA activities
- Works efficiently and meets deadlines and deliverables. Able 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
- A high level of attention to detail and accuracy is essential
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!