Product Quality Manager
Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.
Join us at Karo Healthcare on our exciting journey. We're currently looking for a Product Quality Manager for our office in Stockholm.
What’s in it for you?
- A visible, hands-on quality role with real impact on products sold globally
- Exposure to international suppliers, CMOs, and cross-functional teams
- A fast-moving, growth-oriented environment where you can shape processes and develop your career
- The chance to work in a company combining FMCG speed with pharmaceutical quality standards
What you’ll be doing
- Act as a key Quality representative for Contract Manufacturing Organisations (CMOs), ensuring compliance with GMP, GDP and Directive 2001/83/EC
- Evaluate, qualify, approve and manage suppliers within Karo’s Global Quality Management System
- Lead and participate in Technology Transfer and validation activities from a QA perspective
- Drive Product Quality Review (PQR), deviation, change control and CAPA processes in line with global QMS
- Take ownership of selected Global QA processes and contribute to a project-driven way of working within the function
- Plan, lead and conduct external audits of CMOs as well as internal audits; approve audit reports and follow up actions
- Ensure product compliance both before and after release, including deviation handling and follow-up
- Review and approve GMP documentation from CMOs (e.g. specifications, validation protocols/reports, stability documentation, manufacturing instructions)
- Issue and/or approve regulatory documentation (Module 3) and co-sign QA agreements where applicable
- Build strong, collaborative relationships with suppliers and internal stakeholders across Quality and Operations
Requirements
Requirements
- University degree in a scientific or technical field; Master’s degree in Pharmacy, Medicine, Chemistry or Chemical Engineering is preferred
- At least 2 years of experience within Quality Assurance in the pharmaceutical and/or medical device industry
- Solid knowledge of GMP, GDP and EU pharmaceutical regulations (including Directive 2001/83/EC)
- Experience working with CMOs and outsourced manufacturing environments
- Comfortable in a fast-paced, hands-on setting with multiple stakeholders and priorities
- Structured, detail-oriented and confident in decision-making within a regulated environment
- Fluent in English; additional languages are a plus
Benefits
- Opportunity to create, grow, and encourage
- Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
- Flexible schedule and life work balance
- Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
- Very positive work environment in a young, international, and motivated team
- Start-up spirit while being a part of the large international organization with strong values
Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.