QA Manager / Qualified Person

R&D Partners; Malmö kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

R&D Partners in Sweden is seeking an experienced QA Manager / Qualified Person (QP) to oversee quality assurance for sterile pharmaceutical products. You will ensure GMP compliance, review batch documentation, and lead investigations and CAPAs within a cross-functional environment.

The role requires eligibility to act as a QP under European legislation, a pharmacy/biomedical degree, and at least five years of GMP pharmaceutical experience.

Qualifications

• Five years’ experience in a GMP-regulated pharmaceutical manufacturing environment.
• Eligible to perform Qualified Person responsibilities under European legislation.
• Experience with deviations, OOS investigations, CAPA and change controls.
• Experience supporting regulatory inspections and audits.
• Sterile/aseptic manufacturing experience is desirable.

Responsibilities

• Review batch documentation and make disposition decisions.
• Investigate quality deviations and assess impact on product quality and compliance.
• Lead OOS investigations and assess associated risks.
• Authorize quality documentation in line with batch disposition outcomes.
• Initiate and approve SOPs, CAPAs, and change controls.
• Participate in regulatory inspections, audits, and internal assessments.
• Provide independent QA oversight to manufacturing activities for GMP compliance.
• Support product complaint investigations and cross-functional projects.
• Provide GMP guidance to manufacturing and other functions.
• Contribute to ongoing quality system improvements.

Skills

Communication skills

English fluency

Project coordination

Stakeholder management

Analytical thinking

Education

Degree in Pharmacy/Pharmaceutical Sciences/Chemistry/Life Sciences

Job description

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.