Quality Assurance Manager

5 months ago

Québec, Canada Centre de production de produits biologiques Inc Full time

The Biologics Manufacturing Centre (BMC) Inc. is a new biomanufacturing facility whose construction was completed in June 2021. The BMC supports the expansion of the country's biologics manufacturing capacity, ensuring that vaccines and other related products can be safely manufactured at home. BMC is designed to create biopharmaceuticals such as viral vector, protein subunit and virus-like particle vaccines and other biologics.

Reporting to the Director, Quality Assurance and Regulatory Compliance, the Quality Assurance Manager plays a crucial role in ensuring the quality and regulatory compliance of pharmaceutical products, by setting up robust quality systems and overseeing their implementation.

He/she ensures the development, maintenance, monitoring, improvement, management and compliance of all quality systems and operational processes in line with biopharmaceutical industry standards, practices, and regulatory requirements.

The **QA Manager** will be responsible for:

- Identifying needs, assessing requirements, proposing solutions based on industry standards, risk management and Quality by Design (QbD), and managing implementation.
- Evaluating and developing strategic and financial capacity plans, aligning sector resources and structure as required to achieve corporate objectives.
- Determining annual quality objectives and identify KPIs that enable the achievement of results by maintaining, improving, and monitoring the various quality assurance systems (QMS).
- Managing a team of professionals (approx. 4-7 people).
- Evaluating and hiring team members, ensuring performance, and providing ongoing feedback.
- Fostering growth and stimulating development of team members through coaching, mentoring, performance plans, professional and technical opportunities.
- Ensuring the development, management and maintenance of the data governance plan.
- Identifying site training needs, adapting training offerings, determining objectives and priorities, and guiding learning transfer requirements.
- Reviewing, approving, or authorizing the content and implementation of internal procedures, those of suppliers as required, and those of customer projects to ensure compliance with Good Manufacturing Practices (GMPs) and internal standards.
- Overseeing the management of controlled documentation - numbering, reviewing, distributing, reconciling, and archiving data.
- Participating as a host in regulatory audits (e.g. Health Canada) and customer audits, as required.
- Promoting a quality culture throughout the site and in all activities and actions.
- Acting as a resource person from a quality point of view for all employees during GMP-related activities.

**You are the person we are looking for if**:

- You hold a bachelor's degree in life sciences (microbiology, biochemistry, etc.).
- You have at least 10 years' experience in a variety of positions within quality assurance, as well as at least 3 years' experience in team management.
- A combination of relevant training and experience may be considered.
- You demonstrate a thorough understanding of all quality processes, operational processes for regulated activities, standards and regulations related to the industry.
- You have experience in recruiting, coaching, and developing team members, and are recognized as a courageous and unifying leader.
- You have emerging business expertise, business acumen and strategic vision.
- You have extensive hands-on experience with software such as eQMS, LIMS, CMMS, ERP.
- You demonstrate a high level of accountability, assuming your responsibilities with confidence and transparency.
- You are able to communicate effectively in French and English with team members, internal and external stakeholders, and regulatory bodies to achieve consensus.

**What we offer**:

- A respectful and friendly work environment in a new facility with state-of-the-art equipment;
- A competitive salary commensurate with your skills;
- Attractive time off allowances;
- A complete range of benefits: group insurance, telemedicine, group RRSP and EAP;
- On-site parking.

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