Quality & PV Compliance Specialist

PharmaRelations AB; Stockholms kommun; On-site; SEK 600,000 - 800,000; Full time

Benefits offered by this job

Collaborative and low-prestige culture

Nordic and international exposure

Strong focus on well-being

Job summary

PharmaRelations AB is seeking a proactive professional for a Quality and Pharmacovigilance role based in Solna, Stockholm. You will manage compliance activities and quality systems, with responsibilities including drafting SOPs, handling deviations, and supporting audits. The ideal candidate has at least 5 years of experience in Quality (GDP/QA) and/or Pharmacovigilance, along with a university degree in Life Sciences. This position offers a hybrid work model and opportunities for long-term development.

Qualifications

• At least 5 years of experience within Quality (GDP/QA) and/or Pharmacovigilance.
• Solid understanding of EU and Nordic regulatory requirements.
• Fluent in Swedish and English, written and spoken.

Responsibilities

• Operate and maintain the GDP/PV quality management system.
• Draft, update and manage SOPs and working instructions.
• Handle deviations, change controls and recalls.
• Support and coordinate distributor audits.

Skills

Quality management

Pharmacovigilance (PV)

Regulatory compliance

Collaboration

Detail-oriented

Self-driven

Education

University degree in Life Sciences (MSc in Pharmacy or equivalent)

Job description

An opportunity for a proactive professional who wants responsibility, pace and long-term development.

Location: Solna, Stockholm (hybrid - approx. 3 days/week on-site)

Employment type: Permanent position (full-time)

Laboratoires Théa is a privately owned pharmaceutical company specialised in ophthalmology, with products available in more than 70 countries worldwide. Théa Nordic was established in 2011 and today employs approximately 30 people across the Nordic region, with the Nordic head office located in Solna, Stockholm.

Role overview

In this role, you will have a broad, hands‑on responsibility for Quality and Pharmacovigilance (PV) compliance activities within Théa Nordic. The position is primarily focused on Quality ownership, combined with a PV scope centred on compliance, documentation and collaboration with global PV functions. The role requires a strong understanding of quality systems and regulatory frameworks, as well as the ability to work independently and take ownership in a Nordic affiliate setting. The position also offers exposure to Market Access‑related activities, such as pricing and reimbursement processes, representing an attractive development opportunity for candidates looking to broaden their competence beyond core Quality work.

Key responsibilities

• Operate and maintain the GDP/PV quality management system.
• Draft, update and manage SOPs and working instructions.
• Handle deviations, change controls and recalls.
• Support and coordinate distributor audits (with support from external consultants).
• Draft and maintain quality agreements with distributors and service providers.
• Review and control documentation related to inbound deliveries.
• Manage stock‑out notifications.
• Act as a quality and compliance point of contact internally in the Nordic organisation and towards headquarters.
• Monitor and interpret new regulations and guidelines within pharmaceuticals, medical devices and cosmetics.

Requirements

• University degree in Life Sciences (e.g. MSc in Pharmacy or equivalent).
• At least 5 years of experience within Quality (GDP/QA) and/or Pharmacovigilance.
• Solid understanding of EU and Nordic regulatory requirements.
• Experience from affiliate or distributed business environments is an advantage.
• Fluent in Swedish and English, written and spoken.
• Knowledge of Finnish is considered a strong asset.

Personal qualities

• Highly structured and detail‑oriented.
• Self‑driven and comfortable taking ownership.
• Pragmatic, yet compliant and quality‑focused.
• Collaborative team player in a small, cross‑functional organization.

What Théa offers

• A stable and entrepreneurial company with a strong growth agenda and robust product pipeline.
• A collaborative, low‑prestige culture with a strong focus on well‑being.
• Nordic and international exposure.
• A role with clear ownership and development potential over time.