SE-CQ Specialist – RP Sweden-Normal

Job Title

Responsible Person (GDP) – Sweden (Contract / Staff Role)

Location: Sweden – Solna or Helsingborg
Work Pattern: Hybrid / Remote (approx. 60–80% remote)
Contract Type: Contractor or Staff
Working Hours: Full-time, 35 hours per week
Reporting Line: Commercial Quality Leadership (Nordics)
People Management: None (lateral leadership across network)

Role Overview

This role will act as the Responsible Person (RP) for Sweden under the Swedish Wholesale Dealer Authorisation, ensuring the licence remains active and compliant to support the commercialisation of medicinal products.

The position requires strong expertise in GDP, Quality Management Systems, and regulatory compliance, with responsibility for maintaining awareness of evolving regulations and their impact on quality practices.

The RP will oversee and execute quality and compliance activities at the Swedish commercial operation, driving continuous improvement in alignment with business objectives. The role acts as a key Quality contact for country operations and collaborates closely with regional and global Quality functions to ensure timely resolution of quality-related issues.

The position plays a critical role in optimising quality systems and processes, ensuring alignment with global quality standards, local regulations, and overall quality strategy, while delivering measurable improvements in quality, cost, and customer value.

Key Responsibilities

Quality Management

• Maintain and implement the local Quality Management System (QMS).

• Manage, escalate, resolve, and communicate quality issues effectively.

• Qualify and approve suppliers with quality impact.

• Establish and maintain Quality Agreements with GxP suppliers.

• Provide Quality input to new projects and initiatives.

• Notify relevant Health Authorities of product shortages in line with local regulations.

Processes & Documentation

• Maintain compliant, effective procedures aligned to business needs.

• Support implementation of regional and global procedures locally.

• Manage local SOPs, work instructions, and quality documentation.

• Contribute to drafting and review of global or regional procedures when required.

• Provide Quality input to marketing, sales, and distribution activities and systems.

Repackaging, Relabelling, Co-Packing & Warehousing

• Oversee product storage and distribution in accordance with GDP and local regulations.

• Define, design, and implement quality requirements for repackaging and relabelling activities.

• Ensure robust product impact assessments and disposition decisions.

As Responsible Person (GDP), responsibilities include:

• Oversight of authorised wholesale activities and record accuracy.

• Ensuring initial and ongoing GDP training programmes are implemented and maintained.

• Coordinating and executing medicinal product recalls when required.

• Managing customer and consumer complaints efficiently.

• Approving suppliers, customers, and subcontracted activities impacting GDP.

• Ensuring self-inspections are conducted and corrective actions implemented.

• Maintaining records of delegated responsibilities.

• Deciding on final disposition of returned, rejected, recalled, or falsified products.

• Approving returns to saleable stock.

• Ensuring compliance with additional national product requirements.

• Maintaining GDP competence through continuous training.

• Ensuring GDP training is delivered to relevant personnel.

Quality Systems

• Ensure effective handling, trending, and mitigation of quality complaints.

• Maintain a robust change control system for quality-impacting activities.

• Manage core QMS elements, including:

  • Deviations / Non-conformances

  • CAPA

  • Document control

  • Training systems

  • Quality Agreements

• Support development projects, artwork changes, recalls, and regulatory interactions.

• Interface with internal Quality teams, supplier sites, and external authorities.

• Provide oversight of key Quality System elements as required by regional leadership.

Compliance & Audits

• Act as Quality representative in Management Reviews.

• Support regulatory inspections, external audits, and internal audits.

• Proactively identify and mitigate compliance risks through audits and compliance programmes.

• Support departmental objectives and quality performance metrics.

• Evaluate quality and distribution processes against regulatory and industry standards.

Key Interfaces

• Product Quality

• Manufacturing Quality

• Commercial Quality

• Supply Chain

• Regulatory Affairs

• Digital Quality

• Commercial Operations

• Distribution & Transportation Leadership

Qualifications

• Eligibility to act as a GDP Responsible Person under Swedish regulations.

• Degree in Life Sciences, Engineering, Scientific, or Business discipline.

• Strong background in Quality Systems and Continuous Improvement.

• Experience working with regulatory authorities and resolving complex compliance issues.

• Hands-on experience with KPIs, Change Control, Audits, CAPA, and QMS frameworks.

• Strong technical writing and data communication skills.

Competencies

• Strategic quality mindset with a business outcome focus.

• Strong analytical and problem-solving skills.

• Ability to prioritise and manage complexity.

• Effective communication and change leadership.

• Comfortable working in matrixed, virtual, and cross-functional environments.

Languages

• Fluent English required.

• Additional European languages advantageous.