Senior Quality Specialist – GCP

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, and cholera, and we have exciting product launches coming up. 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 QA Expert to our Development team in the QA department. In the QA Development team, we are devoted to managing a robust quality management system to assure data integrity and subject safety throughout the product development and 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 directly to the head of R&D and CSPV QA and be part of a team of Quality Assurance Staff located at our sites in Germany, Denmark, and the US that are supporting GCP, 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 the development program for compounds under development
• Establish appropriate activities supporting the management and oversight of quality for applicable compounds, processes, and organizations
• 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 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.

Skills

• 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 quality-oriented work supporting clinical trials
• Experience in developing audit and/or quality oversight strategies in GxP areas
• Experience in 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

Salary Range: $130k-180k

Location: Hybrid or remote position – US Headquarters, Durham, NC

• East Coast Preferred

We offer
A chance to work in an international company with unique technology and a dedicated workforce. We offer to be 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. We offer a comprehensive benefits plan and a competitive compensation package.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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.

Department:
Durham, NC, US, Durham

Lokation: USA

Application deadline: 05 May 2024