Head of Quality Uppsala

Job Title: Head of Quality (Uppsala, Sweden)

About the Role: We are seeking an experienced and inspirational Head of Quality to lead and transform our Quality function at our site in Uppsala, Sweden. This is a critical leadership role where you will shape a proactive, patient‑focused, and risk‑aware quality culture within a highly regulated pharmaceutical/biotech environment. As a key member of the leadership team, you will ensure full compliance with global regulatory standards while driving operational excellence, continuous improvement, and integration of quality across all phases of product development and manufacturing.

Key Responsibilities

• Lead the site’s Quality strategy, governance, and execution, ensuring full compliance with GMP/cGMP and international regulations.
• Act as the primary Quality authority during regulatory inspections (e.g., EMA, FDA and other global agencies).
• Oversee and continuously improve the Quality Management System (QMS) covering QA, QC, validation, and regulatory compliance.
• Ensure the approval and release of raw materials, packaging, intermediates, and finished products.
• Drive management of deviations, CAPAs, change controls, and customer complaints.
• Own supplier quality management, audits, and qualification processes.
• Lead internal and external audits and ensure inspection readiness at all times.
• Oversee analytical, microbiological, and product quality control activities.
• Ensure compliance with marketing authorizations and regulatory submissions.
• Lead validation and qualification activities (equipment, systems, processes, computerized systems).
• Build and lead a high‑performing Quality organization, including hiring, development, and performance management.
• Define and manage Quality budgets and resources.
• Contribute to site strategy and business planning as a key member of the Management Team.
• Embed Health, Safety & Environment (HSE) principles into all quality‑related activities.

What We’re Looking For

Required Experience Mandatory

• Extensive experience in pharmaceutical and/or biotechnology environments.
• 10–15+ years of progressive experience in Quality (QA/QC) with significant leadership responsibility.
• Proven track record managing regulated manufacturing environments.

Education

• Bachelor’s or Master’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Microbiology, Chemical Engineering).

Technical Expertise

• Deep knowledge of GMP/cGMP regulations (EMA, FDA, ICH).
• Strong experience with regulatory inspections and audits (FDA/EMA).
• Expertise in QMS, validation, and regulatory compliance.
• Solid understanding of product lifecycle and regulatory submissions.
• Experience in project management and change management.

Leadership Skills

• Strategic and hands‑on leader with the ability to drive cultural transformation.
• Strong stakeholder management and communication skills.
• Ability to lead through complexity in a high‑growth, high‑regulation environment.

Languages

• Fluent in English (written and spoken).

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