QARA Pharma Manager

Every day we get opportunities to make a positive impact on our colleagues partners customers and society. Together were pioneering the solutions of the future and unlocking the full potential of precious resources. Trusted to act on initiative we challenge conventional thinking to develop world-leading technologies that inspire progress in vital areas including energy food water and shipping.

As we push forward the innovative open spirit that fuels our 140-year-old start-up culture and rapid growth also drives our personal growth. So as we shape a more resourceful less wasteful world we build our careers too.

About The Job

As QA/RA Managerfor Pharma at Alfa Laval you will play a central role in shaping and driving our quality and regulatory setup for pharmaceutical applications. You will establish and maintain a robust scalable Quality Management System while ensuring full compliance with relevant standards such as ISO 9001 ISO 13485 and cGMP. Acting as the key interface towards authorities customers and internal stakeholders you will translate complex regulatory requirements into practical value-adding ways of working.

In this role you will operate at the intersection of quality regulation and business. You will support product development manufacturing and commercial teams by embedding compliance early in processes while also driving a strong quality culture across the organization. As a strategic partner you will enable sustainable growth in the pharmaceutical segment by ensuring that quality and compliance become competitive advantages.

Key responsibilities:

• Develop implement and continuously improve the Pharma Quality Management System (QMS)

• Ensure compliance with applicable pharmaceutical regulations and standards (e.g. ISO cGMP FDA EMA)

• Act as the primary QA/RA contact towards regulatory authorities notified bodies and customers

• Lead and manage internal supplier and customer audits including follow-up on findings

• Establish and govern processes for deviations CAPA change control and risk management

• Support product development and lifecycle management to ensure compliance is built in from early stages

• Review and approve validation strategies protocols and relevant technical documentation

• Monitor regulatory developments and translate them into actionable internal requirements

• Drive a strong quality culture through training coaching and continuous improvement initiatives

• Define and track quality KPIs to ensure transparency performance and ongoing optimization

At Alfa Laval we embrace a hybrid work model providing you the flexibility to work from home when it aligns with your tasks. This position is at our Kolding office with an expected travel commitment of approximately 20 days per year.

What You Know

• Bachelors or masters degree within Life Sciences Pharmacy or a related field

• 7 years of experience within QA/RA in the pharmaceutical biotech or other regulated industries

• Strong knowledge of relevant standards and regulations including ISO 9001 ISO 13485 cGMP and FDA 21 CFR Part 11

• Experience with risk management (e.g. ISO 14971) and validation processes

• Proven ability to establish maintain and improve quality management systems in a global environment

• Experience in conducting internal and external audits and ensuring an organization is ready for audit

• Experience working cross-functionally and managing multiple projects simultaneously

• Strong communication organizational and stakeholder management skills

• Fluency in English both written and spoken and preferably also in a Scandinavian language

About You

You work effectively across functions and can influence and align stakeholders without formal authority. You communicate in a clear structured and timely manner ensuring transparency and alignment across a wide range of stakeholders. With a solid understanding of quality and regulatory requirements you are comfortable navigating complex standards and translating them into practical and value-adding ways of working.

You take a structured and analytical approach to problem solving and are confident in challenging existing practices to drive improvements. At the same time you build strong and constructive relationships both internally and externally including with customers and regulatory authorities. You bring a proactive mindset and a focus on continuous improvement applying LEAN principles relevant to strengthen both quality and efficiency.

For more information please contact.

Head of Research & Development Vice President BU Hygienic Fluid Handling Rikke Kau Breinholt

Senior Talent Acquisition Partner Claus Wiinholt

Please send your application and resume through the link below no later than 17th of May 2026

We are conducting a continuous review of received applications. We do not accept applications via email they will be deleted due to General Data Protection Regulation (GDPR).

We look forward to hearing from you soon!

We care about diversity inclusion and equity in our recruitment processes. We also believe behavioral traits can provide important insights into a candidates fit to a role. To help us achieve this we apply Pymetrics assessments and upon application you will be invited to play the assessment games.

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