Senior Quality Assurance Specialist - GCP

Bavarian Nordic; Golden Horseshoe; On-site; CAD 80,000 - 110,000; Full time

Job summary

Bavarian Nordic is seeking a Senior Quality Assurance Specialist - GCP to join their R&D QA team. The role involves ensuring quality management systems are upheld throughout clinical development, managing audits, and preparing for regulatory inspections. This position offers competitive salary, professional growth, and the chance to contribute to life-saving vaccine development.

Benefits

Flexible work-from-home possibilities

Opportunity for advancement and professional learning

Dynamic and flexible work environment

Qualifications

• Minimum 7 years of experience in QA supporting clinical trials.
• Demonstrated knowledge of ICH GCP and global regulations.
• Experience of preparing for and hosting regulatory inspections.

Responsibilities

• Manage quality oversight for clinical trial programs.
• Prepare and host regulatory inspections.
• Support development and maintenance of the Quality Management System.

Skills

Analytical skills

Problem-solving

Decision-making

Project management

Fluency in English

Education

University degree (B.Sc or above) in natural sciences

Job description

Senior Quality Assurance Specialist - GCP

Join to apply for the Senior Quality Assurance Specialist - GCP role at Bavarian Nordic

Senior Quality Assurance Specialist - GCP

Join to apply for the Senior Quality Assurance Specialist - GCP role at Bavarian Nordic

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Senior Quality Assurance Specialist – GCP (m / f / d)

Protecting Our Tomorrow

At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against smallpox, mpox, rabies, tick-borne encephalitis, typhoid fever, chikungunya and cholera. We excel in R&D innovation, manufacturing, and commercialization, striving to improve the health and quality of life for people worldwide, ultimately protecting our tomorrow. Join us in our mission to make a difference.

Boost Our Team

Become the trusted Quality Assurance Expert to our R&D QA team in the QA department!

In the R&D QA team, we are devoted to managing a robust quality management system to assure data integrity and subject safety throughout the product development from Phase I-III clinical trials all the way though to post marketing, to secure regulatory requirements and expectations.

Our team is embedded into a larger quality organization, dedicated to accompanying Bavarian Nordic through an exciting phase of new products, markets and business areas.

You will be reporting to directly to the head of R&D QA and be part of a team of a Global Quality Assurance Staff located in Germany, Denmark, Canada and in the US that are supporting GCP, GLP, GCLP and Pharmacovigilance, providing opportunities for cross-functional collaborations and interesting development opportunities.

Bavarian Nordic is growing in many aspects and offers an opportunity for advancement and learning and provides flexible work-from-home possibilities made in agreement with your manager.

Your Responsibilities

Our vaccines make a real difference to people, and no matter your role we all contribute to protecting lives every day. This is how your work matters :

• Collaborate with stakeholders in the development department to support clinical trial programs for Bavarian Nordic compounds in our pipeline and for marketed products.
• Establish appropriate activities supporting the management and oversight of quality for clinical trial programs and processes, Investigational sites and vendors
• Support inspection readiness activities
• Prepare and host inspections from regulatory authorities
• Maintain and track change control, investigations, deviations and CAPAs to closure
• Support the development and maintenance of the corporate GCP audit programs
• Perform internal and external audits as a lead auditor or as a co-auditor
• Support with oversight over subcontracted contracted audit programs
• Support development, maintenance and continuous improvement of the Quality Management System (QMS)
• Participate in development projects and provide support in the context of clinical risk management.
• University degree (B.Sc or above) in natural sciences or a comparable qualification
• Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials – demonstrated knowledge of pharmacovigilance strongly preferred.
• Minimum 7 years of experience in QA or in quality-oriented work supporting clinical trials
• Experience of developing audit and / or quality oversight strategies in GxP areas
• Experience of preparing for and hosting regulatory inspections
• Knowledge of applied risk management and the review of continuous risk management
• Demonstrated strong analytical, problem-solving, and decision-making skills
• Demonstrated experience in managing projects
• Fluency in written and spoken English

We offer

A chance to work in an international company with unique technology and a dedicated workforce. We offer being part of a dedicated and agile global regulatory affairs team. We welcome people who share our passion for regulatory affairs with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies.

Caught your interest?

If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

www.bavarian-nordic.com

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Pharmaceutical Manufacturing

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Quality Assurance Specialist • Golden Horseshoe, Durham Region, Canada