Senior QA Manager Validation & Quality
Position summary: Senior QA Manager Validation & Quality
This role combines deep expertise in validations (e.g process, cleaning, analytical method) from a quality perspective with strong capabilities in quality systems, supplier qualification, and risk-based compliance. The role will act as a subject matter authority for validation and QA processes, supporting cross-functional teams and driving quality excellence across internal operations and external suppliers.
Key tasks and responsibilities
• Provide strategic and operational direction for quality expectation including validation within drug substance and drug product process development, scale-up, technology transfer, and manufacturing activities.
• Oversee development and implementation of quality and validation processes to ensure compliant, robust and cost-effective manufacturing processes for development, clinical and commercial supply.
• Manage external manufacturing partners (CDMOs/CMOs), ensuring alignment with quality expectations and program objectives
• Support authority inspection and internal Hansa/external audits of suppliers and vendors
• QA review and approval of validation documentation
• Partner cross-functionally with CMC, Regulatory, Clinical, Supply Chain
• Establish and maintain strong relationships with internal and external stakeholders to ensure seamless execution of QA strategies and operational tasks.
• Drive continuous improvement initiatives such as -evaluate and update the Quality Management System (QMS), proactively identify areas for improvement
Education and experience requirements
• Advanced degree (Ph.D. or M.S.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline.
• 15+ years of relevant biopharmaceutical industry experience, including significant roles in QA process development, manufacturing and validation.
• Strong knowledge and experience of biotech and aseptic manufacturing incl testing
• Deep understanding of regulatory requirements (FDA, EMA, ICH) related to development, manufacturing and validation
• Strong experience managing external partners and CDMOs/CMOs.
• Strong experience of Authority inspections as presenter, coordinator (FDA, EMA and other markets)
• Proven track record of leading validation activities for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages.
• Strong communication, and interpersonal skills with the ability to influence across functions and levels.
• Strong problem-solving skills and a hands-on, execution-oriented mindset.
Our culture and values
Working at Hansa is more than a job for us, and our culture is characterised by pride — pride in what we do, in our company, and in what we have achieved and will accomplish for patients around the world.
Our culture is built on our core values: Accountability, Courage, Integrity, and Pioneering. These values guide how we work, collaborate, and make decisions every day.
We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve.
Reasons to join the Hansa Team
- A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions.
- The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people.
- An opportunity to build a fully integrated biopharmaceutical company with global outreach.
- An open-minded and welcoming atmosphere. Friendly, motivated and skilled colleagues with whom you can both laugh and work.
Type of employment and location
- This is a permanent and full-time (40 hours) position.
- This position is based in Lund, Sweden.
- This position requires regular on-site presence, with an expectation of at least four days per week in the office.
The process
Please apply for the position through the following link: Senior QA Manager Validation & Quality - Hansa Biopharma. Applications should not be sent through any other platform.
Attach your CV in English only. Unfortunately, we are unable to review applications made in other languages.
The process is ongoing and we will review applications as they are received.
We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research!
Please note: No external recruitment support is required. Only applications received directly will be considered.