Head of QA

Coloplast

Hörby, Sweden

About the Role

In this position, you will set the direction for quality assurance at our Hörby site while ensuring compliance and driving continuous improvement. You will lead a dedicated team of 13 professionals, working closely with our Site Director and maintaining a dotted-line collaboration with Coloplast's Global Quality leadership. This is a strategic, hands-on role where you will contribute to both the site’s quality operations and broader organizational goals.

Key Responsibilities

Lead and develop a team of 13 skilled QA professionals, ensuring their growth and engagement.
Drive and maintain the Quality Management System (QMS), including external audits, CAPA and nonconformity processes.
Act as the main point of contact for regulatory bodies and manage compliance with notified body requirements.
Oversee quality performance metrics (QPI) and ensure alignment with Coloplast’s global QA strategies.
Support integration activities, ensuring smooth QMS transitions in line with Coloplast's standards.
Provide strategic input to the site’s management team and influence key decisions related to quality assurance.
Collaborate with cross-functional teams to align QA initiatives with business and operational objectives.
Engage in and lead internal audits, quality projects, and continuous improvement initiatives.

About You

You are a pragmatic, results-oriented leader who thrives in dynamic environments. You excel at switching between the helicopter perspective and a hands-on approach, knowing when to dive into details and when to rely on your team of experts. With strong stakeholder management skills, you build solid relationships and guide your team through change with a structured approach.

Qualifications & Experience

Degree in engineering, pharmaceutical science, or a related field.
Proven experience as a people leader in a regulated industry.
Experience in a strategic role with exposure to quality assurance or quality control.
Strong business acumen, with the ability to navigate both operational and strategic challenges.
Excellent communication skills in English (Swedish is a plus).

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