Digital Quality System Lead and Digital Quality System Manager

Posted 8 Days Ago
Be an Early Applicant
2 Locations
Hybrid
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead or manage digital quality system capabilities in a regulated pharmaceutical environment. Responsibilities include translating quality and user needs into system improvements, coordinating development and lifecycle activities, supporting validation and testing, managing changes and releases, improving automation and AI-enabled processes, maintaining documentation, and supporting users. The Lead additionally manages the team, sets priorities, coaches employees, and establishes effective stakeholder collaboration and decision-making practices.
Summary Generated by Built In

Drive the development of reliable, user-friendly and compliant digital quality systems

At Orion Pharma, our mission is to build well-being through innovative medicines and solutions. We are now looking for two professionals for our new Digital Quality System team: a Digital Quality System Lead, who will act as the team’s people manager, and a Digital Quality System Manager, who will work as a specialist in the team. Both positions combine ownership with active hands-on contribution to the development, lifecycle management and continuous improvement of digital systems and tools used in Quality Management. 

These are full-time positions based in Espoo or Turku, Finland. Orion supports a hybrid working model, with employees working onsite three days per week and remotely for up to two days per week.

Your role

In both roles, you will manage and develop digital quality system capabilities in close collaboration with Quality Management, Information Management, system owners, process owners and external partners. Together with your colleagues, you will ensure that our digital quality systems are reliable, user-friendly, compliant and aligned with evolving business and regulatory needs. You will translate quality management priorities and process needs into practical system improvements, drive the implementation of enhancements and help build more efficient, digitally supported and increasingly automated ways of working across Quality Management, including the appropriate use of AI-enabled solutions. The Lead will additionally provide people leadership, set the team’s direction and priorities, and establish effective ways of working. 

Responsibilities

Responsibilities shared by both roles

  • Work proactively with stakeholders and users to understand business needs, pain points and improvement priorities
  • Translate user needs, quality process requirements and regulatory expectations into practical system functionalities and improvements
  • Identify and prioritize opportunities to improve usability, data quality, automation, AI-enabled support, reporting and overall system performance
  • Lead, coordinate and make hands-on contributions to system development, implementation and continuous improvement activities
  • Take part in and oversee system lifecycle activities, including requirement definition, testing, validation support, change requests, release coordination and issue resolution
  • Ensure that deliverables are implemented in a compliant, well-documented and user-oriented manner
  • Support adoption through communication, training, structured user support and practical guidance
  • Create and maintain system documentation and user guidance for compliant and effective system use
  • Drive cross-functional decision-making and prioritization to ensure that digital quality system initiatives are delivered effectively and within agreed scope

Additional responsibilities of the Digital Quality System Lead

  • Lead and develop the Digital Quality System team in line with agreed objectives
  • Set clear priorities, responsibilities and expectations, and monitor progress towards team goals
  • Coach, support and empower team members and foster their professional development
  • Build a collaborative, service-oriented and improvement-driven team culture
  • Establish effective ways of working and stakeholder forums to support alignment, prioritization and decision-making

What you can expect from us

We offer you a unique opportunity to shape the future of digital quality management at Orion and contribute to solutions that enable efficient, compliant and user-friendly quality processes across the organization. As part of a newly established team, you will be able to influence its ways of working, priorities and solutions from the outset while developing your expertise in digitalization, automation and AI-enabled solutions in a highly regulated environment. You will work with experienced colleagues across the organization in an open and collaborative culture, where your ideas are valued and continuous learning and professional growth are actively supported.

At Orion, your work creates true impact and well-being for our customers, patients and society at large. ​ ​Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.

What are we looking for?

Requirements for both roles

  • A relevant degree in information systems, engineering, life sciences, pharmacy or another applicable field
  • At least five years of experience with digital business systems, preferably quality management systems or other regulated systems
  • Experience in system development, implementation, testing, validation support, change management or lifecycle management in a GxP or otherwise regulated environment
  • Ability to translate business, user and process requirements into practical system solutions and prioritised development actions
  • A structured, hands-on and improvement-oriented approach, with the ability to resolve issues and deliver concrete outcomes
  • Strong collaboration, communication and influencing skills and the ability to work effectively with vendors, IT/IM teams, business users and senior stakeholders in a matrix environment
  • Proven track record in applying automation, analytics and AI-enabled solutions to improve processes and user experience in a regulated environment
  • Ability to work effectively under pressure and respond appropriately to changing situations
  • Experience with pharmaceutical quality processes is considered an advantage
  • Excellent written and spoken English
  • Sufficient Finnish language skills for effective workplace communication

For the Digital Quality System Lead role, we are also looking for

  • Ability to set direction, clarify priorities and create alignment
  • Motivation and potential to lead, support and develop team members towards shared goals
  • Previous people management experience is an advantage

How to apply

If these roles match your interests and professional aspirations, please submit your application by September 20, 2026. Please, indicate whether you are applying for the Digital Quality System Lead role, the Digital Quality System Manager role or both. We review applications throughout the application period and may invite suitable candidates to interview before the closing date, so we recommend applying at your earliest convenience.

For more information about the roles, please contact Satu Ahvas, Director, Quality System, tel. 050 966 7710 (11.9. at 10-11, 15.9. at 14-15 and 17.9. at 10-11).

#LI-ORION

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.

Your new team

Quality management (QM) is responsible for ensuring the quality of materials, products and operations, as well as maintaining and developing the quality system and monitoring the regulatory environment. Pharmacovigilance and Patient Safety unit is responsible for the global pharmacovigilance system of Orion Corporation and for the continuous safety surveillance, regulatory reporting and safety risk management activities of human and veterinary medicinal and non-medicinal products.

The QM function consists of about 400 experts who work in Quality Control, Quality Assurance, Quality System, Method Development and the Pharmacovigilance & Drug safety unit. We are located in Espoo, Turku, Salo and Kuopio plants, in addition to the Quality Assurance team in India reporting dotted-line to QM.

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.

About Orion

Skills Required

  • Relevant degree in information systems, engineering, life sciences, pharmacy, or another applicable field
  • At least five years of experience with digital business systems, preferably quality management systems or other regulated systems
  • Experience with system development, implementation, testing, validation support, change management, or lifecycle management in a GxP or otherwise regulated environment
  • Ability to translate business, user, and process requirements into practical system solutions and prioritized development actions
  • Structured, hands-on, and improvement-oriented approach with the ability to resolve issues and deliver concrete outcomes
  • Strong collaboration, communication, and influencing skills in a matrix environment
  • Experience working with vendors, IT or information management teams, business users, and senior stakeholders
  • Proven experience applying automation, analytics, and AI-enabled solutions to improve processes and user experience in a regulated environment
  • Ability to work effectively under pressure and respond appropriately to changing situations
  • Excellent written and spoken English
  • Sufficient Finnish language skills for effective workplace communication
  • Experience with pharmaceutical quality processes
  • For the Lead role, ability to set direction, clarify priorities, and create alignment
  • For the Lead role, motivation and potential to lead, support, and develop team members
  • Previous people management experience for the Lead role
  • Successful completion of an approved medical examination including drug testing before employment
  • Completion of a security clearance before employment
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The Company

What We Do

Orion is a globally operating Nordic pharmaceutical company and builder of well-being. Rooted in Nordic values of trust and openness, the company focuses on developing treatments and conducting research to empower people to live their lives to the fullest. Operating in over 35 countries, Orion drives innovation in healthcare to improve health outcomes for millions of people worldwide.

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