SE‑CQ Specialist

Join us as a SE‑CQ Specialist and take a key role in safeguarding the quality and compliance of medicinal products in Sweden. You will oversee the local Quality Management System, ensure GDP compliance, and act as the primary authority for quality-related matters across the Swedish operation. If you excel in regulated environments and enjoy driving quality and continuous improvement, this role offers the chance to make a meaningful impact.

Location: Helsingborg

Remote work: 60-80%

Workload: Full-time, 35 h/week (100%)

Reports to: Commercial Quality Lead - Nordics

Job Purpose

We are seeking an experienced SE‑CQ Specialist / Responsible Person (RP) to ensure GDP compliance and maintain the Swedish Wholesale Dealer Authorisation for medicinal products. In this role, you will oversee the local Quality Management System, ensure alignment with global and local regulations, and act as the primary quality contact for the Swedish organization. You will support continuous improvement, manage quality issues, and collaborate across multiple quality functions to secure timely and compliant operations.

Within Quality Management, the role is responsible for maintaining and implementing the local Quality System while actively managing, escalating, and resolving quality issues as they arise. The position includes qualifying and approving suppliers that impact product quality, as well as establishing and maintaining Quality Agreements with relevant GxP partners. The specialist also contributes with quality expertise to cross-functional projects and ensures that any product shortages are reported to the authorities in accordance with local regulations.

Processes

The role ensures that all procedures remain compliant, effective, and aligned with business needs. It supports the local implementation of regional and global procedures and oversees the management of SOPs, work instructions, and associated documentation. Additionally, the position provides quality-related input to marketing, sales, and distribution activities to ensure that all operational areas adhere to applicable quality standards.

Repack, Relabel, Co‑packing & Warehousing

• Oversee product storage and distribution according to GDP and local regulations.
• Define and implement quality requirements for repackaging and relabelling.
• Perform product impact assessments and disposition decisions.
• Fulfil all RP responsibilities, including:
• Managing authorized activities and documentation
• Ensuring training programs are maintained
• Coordinating recalls
• Handling customer/consumer complaints
• Approving suppliers, customers, and subcontractors
• Ensuring self-inspections and corrective actions
• Managing delegated duties and product returns
• Maintaining GDP competence and ensuring GDP training for relevant roles

Quality Management Systems

• Ensure proper handling and trending of complaints.
• Maintain effective Change Control.
• Manage QMS elements: NC/CAPA, documentation, training, Quality Agreements.
• Support development projects, artwork changes, recalls, and regulatory interactions.
• Oversee key QMS elements as assigned by the Cluster Head.

Compliance

• Represent Quality in Management Reviews.
• Support Health Authority inspections and internal/external audits.
• Identify and mitigate compliance risks.
• Support departmental KPIs and objectives.
• Evaluate quality and distribution processes against regulatory and industry standards.

Key Interfaces

Product Quality, MAKE Quality, Commercial Quality, Supply Chain, Regulatory, Digital Quality, Commercial teams, Deliver & Transportation Leadership.

Qualifications

• Meets requirements to act as a GDP Responsible Person.
• Bachelor's degree in Life Sciences, Engineering, Scientific or Business fields.
• Strong background in Quality Systems and Continuous Improvement.
• Experience working with regulatory agencies and complex compliance issues.
• Knowledge of KPI frameworks, QSMR, Change Control, Audits, CAPA.
• Strong technical writing and data communication skills.

Competencies

• Strategic quality mindset with business focus.
• Strong analytical and problem-solving skills.
• Effective communicator with change management capability.
• Organized and comfortable working in complex, cross‑functional environments.

About Jefferson Wells

Manpower is Sweden's leading recruitment and staffing company with tens of thousands of attractive employers across the country as our clients. With our extensive network, both locally and globally, we can offer a multitude of exciting job opportunities that help you build your career, both in the short and long term. With us, you can apply for full-time jobs or part-time jobs alongside your studies.

Application

You will be employed as a consultant at Manpower and work on assignment for the client. Selection is ongoing, and the position may be filled before the application deadline. If you have questions about the position, please contact the responsible Gentrit Ajdini, [email protected]