Senior QA Manager Validation & Quality

Hansa Biopharma AB; Lunds kommun; On-site; SEK 1,400,000 - 1,900,000; Full time

Job summary

Hansa Biopharma AB in Lund, Sweden, is seeking a Senior QA Manager Validation & Quality to lead validation strategy for drug substance and product development, scale-up, tech transfer and manufacturing activities.

You will drive QA processes, manage external CDMOs/CMOs, support regulatory inspections, and ensure compliant, robust manufacturing for development, clinical and commercial supply with a strong emphasis on risk-based compliance.

Qualifications

• Advanced degree required in chemical engineering, chemistry, pharmaceutical sciences or related field.
• 15+ years in biopharmaceutical QA, process development, manufacturing and validation.
• Experience with biotech/aseptic manufacturing and regulatory inspections (FDA/EMA/ICH).
• Strong communication and ability to influence across functions and levels.

Responsibilities

• Provide strategic and operational direction for validation within drug substance and drug product development, scale-up, tech transfer and manufacturing.
• Oversee development and implementation of QA/validation processes for compliant, robust manufacturing for development, clinical and commercial supply.
• Manage external partners (CDMOs/CMOs) aligning with quality expectations and program objectives.
• Support authority inspections and internal/external audits of suppliers and vendors.
• QA review and approval of validation documentation.
• Partner with CMC, Regulatory, Clinical, Supply Chain across functions.
• Establish relationships with internal and external stakeholders to ensure seamless QA execution.
• Drive continuous improvement of QMS and proactive quality improvements.

Skills

Communication skills

Interpersonal skills

Problem solving

Execution mindset

Education

PhD/MS in relevant field

Job description

About Us

Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with acute or complex immune disorders. Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation. By empowering our people we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey. Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.

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.