Director Quality Operations
Valneva is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers, one for the prevention of Japanese encephalitis and one for the prevention of cholera. Valneva has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 480 employees. The Swedish site was previously owned by Crucell and SBL Vaccine. Approximately 150 staff members work here. For more information, please visit www.valneva.com.
Do you want to support increased GxP demands in pharmaceutical production?
Do you want to bring manufacturing quality to the next level?
Do you want to make a true difference as a leader of the whole site quality department?
Then maybe you are the one we are looking for as:
Director Quality Operations, Sweden
On behalf of our client, Valneva AB, H&P Search & Interim is now looking for a dedicated and experienced Director Quality Operations, to oversee that our vaccine manufacturing is in compliance with current GMP/GDP regulations and internal standards and procedures. This position will report directly to the Managing Director Industrial Operations and functionally to the Vice President Global Quality and work closely with the Site Manufacturing Team. The position is based at the Valneva production facilities in Solna, Sweden.
- Site functional lead for Quality; Local line management responsibilities for Quality Assurance, Quality Control and Regulatory Affairs
- Lead and develop local site Quality teams
- Budget control for function at site
- Quality oversight of the site GMP/GDP, CMO, suppliers and service providers
- Responsible for the local Quality Management System and implementation of and adherence to the Global QMS
- Ensure the site is ready for inspection at all times
- Ensure Regulatory Compliance by supporting the Regulatory Affairs department where appropriate
- Set GMP/GDP quality standards, as part of the Global Quality Leadership Team
- Lead site Quality escalation to senior management, primarily Site Management Board and VP Global Quality
- Provide Quality, GMP/GDP and regulatory guidance and advice at site level
- Develop, collate and report key quality metrics and use these to drive a culture of continuous process improvement and compliance
- Chair the Quality Review Board for the site
- Represent Site Quality in the Site Executive Team and Industrial Operations Management Team
- Represent Site Quality in the Global Quality Leadership Team and in Product Safety Committee
Bachelor’s degree in Natural Sciences, with extensive work experience in the Life science or Pharmaceutical industry
Extensive work experience within Quality Assurance and Quality Control in GxP regulated Life Science or Pharmaceutical industry
Experience as QP / RP in EU is desirable
Desirable with experience from the manufacturing of biologicals and aseptic products
Experience from hosting authority inspections
Profound knowledge of relevant GxP (GMP,GDP, GCP, GCLP) legislation for the EU, US and Canadian markets
Used to work in an international environment with various cultures is desirable
Excellent knowledge with regards to all quality and regulatory related standards and regulations
Who are you?
We are looking for an individual with strong management and leadership skills with the experience and ability to motivate and engage. You are an open-minded team-player with great communication and influencing skills and longtime experience from working cross functional. You have the ability to make timely, balanced and compliant decisions aligned with business needs. Furthermore, you constantly manage and prioritise workload effectively, both for the organisation as well as on a personal level. As a person you are proactive, solution-oriented and able to act in a fast-changing environment. You have excellent quantitative and analytical skills, taking on tasks with a systematic approach. Strong written and verbal presentation skills in Swedish and English, is another strength of yours. You inspire others through your dedication and passion and you create a culture of ownership and engagement.
If this sounds interesting to you, contact one of us below for more information. Alternatively, you can apply directly by uploading your resume and by emailing us a line.
We look forward to your application!