Hybrid Product Quality Manager

at Karo Healthcare

• Job title: Product Quality Manager
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Stockholm, Sweden

About the role

• Key Quality representative for Contract Manufacturing Organisations at Karo Healthcare. Ensuring compliance with GMP and driving product quality reviews and supplier management.

Responsibilities

• **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