Vi söker en CQ Specialist till Helsingborg!

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.

In terms of 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.

Om Jefferson Wells

Manpower är Sveriges ledande rekryterings- och bemanningsföretag med tiotusentals attraktiva arbetsgivare över hela landet som våra kunder. Med vårt omfattande nätverk, lokalt såväl som globalt, kan vi erbjuda mängder av spännande lediga jobb som hjälper dig att bygga din karriär, både på kort och lång sikt. Hos oss kan du söka heltidsjobb eller extrajobb vid sidan av studierna.

Ansökan

Du blir anställd som konsult hos Manpower och arbetar på uppdrag hos kund. Urval sker löpande och tjänsten kan tillsättas inna sista ansökningsdag. Har du frågor om tjänsten är du välkommen att kontakta ansvarig Gentrit Ajdini, [email protected]