Senior QA Manager Validation & Quality

Hansa Biopharma; Lunds kommun; On-site; SEK 1,400,000 - 2,100,000; Full time

Job summary

Hansa Biopharma in Lund, Sweden, seeks a Senior QA Manager Validation & Quality to lead validation strategies for drug substance and drug product across development, scale‑up, technology transfer and manufacturing.

You will drive quality systems, supplier qualification and risk‑based compliance, oversee CDMOs/CMOs, support inspections and audits, and collaborate with CMC, Regulatory, Clinical and Supply Chain to ensure robust, compliant operations for clinical and commercial programs.

Qualifications

• PhD or MS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline.
• 15+ years of biopharmaceutical QA, process development, manufacturing and validation.
• Strong knowledge of biotech aseptic manufacturing incl testing.
• Deep understanding of FDA, EMA, ICH regulatory requirements.
• Experience managing external partners and CDMOs/CMOs.
• Experience with Authority inspections (FDA, EMA and other markets).
• Proven track record leading validation activities for drug substance and drug product development, scale‑up and manufacturing for clinical and commercial stages.
• Excellent communication and cross-functional collaboration.
• Hands-on, execution‑oriented mindset.

Responsibilities

• Provide strategic and operational direction for quality including validation within drug substance and drug product development, scale‑up, technology transfer, and manufacturing.
• Oversee development and implementation of quality and validation processes for compliant, robust and cost‑effective manufacturing.
• Manage external manufacturing partners (CDMOs/CMOs) to align with quality goals.
• Support authority inspections and internal and 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 relationships with internal and external stakeholders for QA strategies.
• Drive continuous improvement of the Quality Management System (QMS).

Skills

Communication

Interpersonal skills

Problem solving

Execution mindset

Stakeholder management

Education

PhD or MS in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmacist or related discipline

Job description

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 evaluating and updating the Quality Management System (QMS), proactively identifying 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.

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.

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.