Are you an expert in qualification and validation of Equipment and Infrastructure within Good Manufacturing Practice-regulated environments? Are you motivated by the opportunity to shape quality systems in a new or evolving manufacturing facility? If so, this role may be the next step in your career. We are seeking a highly skilled and experienced Senior QA Manager, QV \& CSV (f/m/d) to join our growing Quality Assurance team.
Boost our team
In this strategic leadership role, you will manage a team of 3 QA Managers and 3 QA Specialists in Qualification \& Validation. You will collaborate across multiple departments, including Engineering, Manufacturing, MS\&T, and Quality Control. Your expertise will help ensure our operations meet regulatory expectations and are Inspection readiness.
You will be based at our manufacturing site in Bern (Thörishaus) and report directly to the Site Director of Quality.
About The Role This position encompasses both strategic oversight and hands-on responsibilities. As the Senior QA Manager, QV \& CSV (f/m/d), you will be responsible for directing the planning and implementation of all equipment, infrastructure, and computer system qualification and validation activities. You will ensure strict adherence to global regulatory standards and internal quality requirements. This role plays a pivotal part in supporting the launch and transformation of manufacturing facilities, including newly constructed sites and modifications to existing structures.
In this position, your primary tasks will include:* Lead the QA review and approval of qualification and validation documentation, including protocols, reports, and risk assessments
Develop and implement validation strategies aligned with GMP, GAMP, FDA, EMA, and internal policies
Support audits, inspections, and investigations related to QV and CSV
EM data trending, room/utility monitoring, QC and method validation, disinfectant and cleaning validation, hygiene and transport validation.
Collaborate with cross-functional teams to ensure compliant and timely execution of validation projects
Mentor and guide team members and stakeholders, fostering a culture of quality excellence
Are you our next pioneer?
To succeed in this role, you will need the following competencies:* Extensive experience in QV and/or CSV within the pharmaceutical or biotech industry
A Bachelor’s degree in engineering, life sciences, computer science, or a related field (Master’s degree preferred)
Proven leadership experience managing validation teams and projects
Deep knowledge of regulatory requirements and qualification/validation lifecycle principles
Strong communication, stakeholder management, and problem-solving skills
Full proficiency in English and German
About you
You are a collaborative and engaging leader who thrives in fast-paced, evolving environments. With a proactive mindset, you actively seek out innovation and lead change within your team. You are not only strategic but also hands-on, always looking for ways to improve systems, processes, and team performance.
You are driven to transform and elevate your team, motivating them to exceed expectations and embrace continuous improvement. As the company grows, you navigate change confidently, and facilitate necessary mindset shifts to support evolving business needs. Your strong leadership, adaptability, and focus on team development make you a key driver of progress and quality in QV and CSV functions.
Ready to take the next step in your QA career and help bringing critical vaccines to market?
Please complete the application form using the “Apply” link. We are interviewing on an ongoing basis and look forward to receiving your CV as soon as possible. It is not mandatory to send a cover letter. Applications submitted via email will not be considered.
We kindly request that head-hunters or recruitment agencies refrain from contacting us regarding this position.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
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