QA Manager / Qualified Person

Ready to make critical quality decisions that safeguard patient health while shaping the future of pharmaceutical manufacturing?

R&D Partners is seeking an experienced QA Manager / Qualified Person (QP) to join a leading pharmaceutical manufacturing organisation in Sweden. This is an excellent opportunity to contribute to the quality oversight of sterile pharmaceutical products within a growing business that supports a diverse international client portfolio.

As part of the Quality Assurance team, you will play a key role in ensuring compliance with GMP and applicable regulatory requirements, supporting manufacturing operations, and driving continuous quality improvements across the organisation.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Review and evaluate batch documentation and make disposition decisions in accordance with regulatory and quality requirements.
• Investigate quality deviations and assess potential impact on product quality and compliance.
• Lead and support Out-of-Specification (OOS) investigations and assess associated risks.
• Authorise quality documentation and certification activities in line with batch disposition outcomes.
• Initiate, review and approve Standard Operating Procedures (SOPs), Corrective and Preventive Actions (CAPAs), and Change Controls.
• Participate in regulatory inspections, customer audits, and internal compliance assessments.
• Provide independent quality oversight to manufacturing activities to ensure adherence to GMP and internal quality standards.
• Represent Quality Assurance within cross-functional projects and support product complaint investigations.
• Provide GMP guidance and quality support to manufacturing and other business functions.
• Contribute to continuous improvement initiatives that strengthen quality systems and operational effectiveness.

Key Skills and Requirements:

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or a related scientific discipline.
• Eligible to perform Qualified Person responsibilities in accordance with relevant European pharmaceutical legislation.
• Minimum of five years’ experience within a GMP-regulated pharmaceutical manufacturing environment.
• Strong knowledge of European GMP requirements and international regulatory expectations.
• Proven experience managing deviations, OOS investigations, change controls, and CAPA activities.
• Previous experience working as a Qualified Person (QP).
• Experience supporting regulatory inspections and external audits.
• Experience within sterile or aseptic manufacturing environments is highly desirable.
• Strong communication skills and fluency in English; additional European language skills are advantageous.
• Effective project coordination and stakeholder management abilities.

Personal Attributes:

• Demonstrates high integrity and sound professional judgement.
• Comfortable making independent, risk-based decisions using scientific and regulatory principles.
• Analytical, organised, and detail-oriented approach to work.
• Strong interpersonal and communication skills, with the ability to build effective working relationships.
• Pragmatic problem-solver with a continuous improvement mindset.
• Adaptable and able to perform effectively in a dynamic and evolving environment.

For more information, please contact Frankie Cunningham.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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