Quality Systems and Regulatory Compliance Manager

4 weeks ago


Solna Municipality, Sweden Cepheid Full time

At Cepheid, we are passionate about improving healthcare through fast, accurate diagnostic testing. Our mission drives us to develop scalable, groundbreaking solutions to solve the world's most complex health challenges. As a member of our team, you will be responsible for managing Quality Systems (QS) processes and related deliverables in conjunction with Company objectives and Regulatory requirements.

The role will be part of the Quality Assurance department and will be located in Solna, Stockholm, Sweden. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

  • Lead and monitor Cepheid AB site audits and Quality system inspections readiness
  • Lead and develop Cepheid Quality System team ensuring Cepheid AB has continuous compliance with the corporate Quality Policies and applicable regulatory requirements
  • Lead the Quality System team to ensure compliant and timely deliverables, such as internal audit program, Quality training program for Cepheid AB, CAPAs, Corrections, etc...
  • Participate to the definition of annual quality goals and quality plans
  • Lead the Quality System Management reviews
  • Monitor Quality key performance indicators and coordinate Problem Solving Plan cross-functional teams where needed
  • Manage CAPA process and ensure compliant and timely deliverables of corrective and preventive actions.

The essential requirements of the job include:

  • University degree in Life Science or related
  • At least five years experience in Quality Assurance, preferably in the diagnostics / medical device industry
  • Excellent skills in written and verbally (English required)
  • Experience of external audits and of working in a global environment
  • Experience or capacity to leading projects or teams

It would be a plus if you also possess previous experience in:

  • Qualified Quality System auditor (ISO9001 – ISO13485)
  • Knowledge of risk management standard (ISO14971) and tools (FMEA, FTA etc..)
  • ISO 13485, 21CFR Part820, MDSAP related regulations

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.



  • Solna Municipality, Sweden Cepheid Full time

    At Cepheid, our team is dedicated to improving healthcare through fast and accurate diagnostic testing. We're passionate about developing innovative solutions to solve complex health challenges. As a key member of our team, you'll be responsible for managing Quality Systems and Regulatory Compliance processes to ensure seamless delivery of our diagnostic...


  • Solna, Sweden Cepheid Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...


  • Solna Municipality, Sweden Cepheid Full time

    About the RoleCepheid is a leading provider of diagnostic solutions, and we are seeking an experienced Quality Systems Manager to join our team. This role will play a crucial part in ensuring compliance with regulatory requirements and maintaining high-quality standards.Job Description:Lead and monitor Cepheid AB site audits and Quality system inspections...


  • Solna Municipality, Sweden Cepheid Full time

    Compliance Associate RoleWe are seeking a highly motivated Regulatory Compliance Specialist to join our team at Cepheid.About the JobThis is a challenging and rewarding role that requires the ability to work in a fast-paced, 24/7 production environment with modified shift times, overtime, and weekends.In this position, you will be responsible for ensuring...


  • Solna Municipality, Sweden Kenvue Full time

    Regulatory Affairs AssociateThis role is responsible for overseeing regulatory activities for assigned medicines, medical devices, cosmetics, and/or food supplements within their geographical and/or brand area of responsibility.Key ResponsibilitiesAssists in the coordination, compilation, and submission of new drug applications, cosmetics, medical devices,...


  • Solna Municipality, Sweden Cepheid Full time

    Cepheid, a leading provider of diagnostic solutions, is seeking a skilled Regulatory Compliance Expert to join our team. Located in Solna, Sweden, this role offers an exciting opportunity to work with cutting-edge technologies and make a significant impact on the healthcare industry.Job OverviewThis position plays a crucial role in ensuring that all product...


  • Solna Municipality, Sweden Kenvue Full time

    Job DescriptionThis is a pivotal role within the Regulatory Affairs department at Kenvue, where you will play a key part in ensuring our consumer healthcare products meet the highest regulatory standards.About KenvueKenvue is a leading household name with over a century of heritage and a commitment to innovation grounded in deep human insights. Our iconic...


  • Solna, Sweden Cepheid Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...


  • Solna Municipality, Sweden IQVIA Full time

    Job OverviewAs a Regulatory and Start Up Specialist 2 at IQVIA, you will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. This role may also include maintenance...


  • Solna Municipality, Sweden Telenor Full time

    Company OverviewTelenor is a leading digital communications company that is rapidly heading towards the future. We are seeking a talented individual to join our digital transformation journey in Sweden.We believe that technology has the power to change lives and we want to be at the forefront of this revolution. As a Senior Quality Assurance Manager, you...

  • Sr QA Scientist

    1 month ago


    Solna Municipality, Sweden Cepheid Full time

    About the RoleCepheid is seeking a highly skilled Sr QA Scientist to join our Quality department in Solna, Stockholm, Sweden. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our diagnostic products.Key ResponsibilitiesRepresent Quality Assurance in project core teams and provide guidance and decisions to...


  • Solna Municipality, Sweden Kenvue Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Associate to join our team at Kenvue. As a Regulatory Affairs Associate, you will be responsible for overseeing a range of regulatory activities for our assigned medicines, medical devices, cosmetics, and/or food supplement consumer products.Key ResponsibilitiesAssist in the coordination,...


  • Solna Municipality, Sweden Telenor Full time

    Transforming Quality At Telenor, we're accelerating our digital transformation, and we're looking for a seasoned Quality Assurance professional to drive our quality initiatives. As a Quality Assurance leader, you'll provide technical leadership and strategic direction for Quality Assurance in Consumer IT. You'll drive initiatives to reach our strategic...

  • Sr QA Scientist

    5 months ago


    Solna, Sweden Cepheid Full time

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and...


  • Vimmerby Municipality, Sweden Arla foods Full time

    Key ResponsibilitiesAs QEHS Manager at Arla Foods, you will be responsible for leading and developing the team to achieve excellence in quality, environment, health and safety. Your inclusive leadership style will ensure a motivating work environment and a focus on employee wellbeing.You will be responsible for:Ensuring compliance with applicable...

  • Quality System Lead

    3 weeks ago


    Köping Municipality, Sweden Hästens Full time

    About the roleHästens is seeking a Quality Management Lead to join our team. As a key member of our organization, you will be responsible for building and maintaining a quality system that can be scaled across the globe as we grow. Your primary focus will be on ensuring the pursuit of mastery in every component and process, from quality control to quality...


  • Solna Municipality, Sweden Cepheid Full time

    {"# Roles and Responsibilities": "Laboratory Compliance AssociateKey Responsibilities:Ensure compliance with regulatory agencies and company guidelines in manufacturing and laboratory environments.Implement and maintain GMP and GLP practices and procedures, serving as a subject matter expert.Conduct regular laboratory inspections and audits to ensure...


  • Vimmerby Municipality, Sweden Arla foods Full time

    Impact and ContributionAs a Quality and Safety Expert at Arla Foods, you will lead and develop a team to excel in solving challenges and finding solutions for safety, quality, and environmental aspects. Your inclusive leadership style will ensure a motivating work environment and employee wellbeing. Key responsibilities include:Ensuring compliance with...


  • Solna Municipality, Sweden Telenor Full time

    About the RoleWe are seeking a highly skilled and experienced Internal Control and Risk Manager to join our Finance Center of Excellence team at Telenor. As a key team player, you will be responsible for implementing and maintaining effective internal control processes, ensuring compliance with regulatory requirements, and identifying and mitigating risks...

  • EHS Manager

    2 weeks ago


    Solna Municipality, Sweden Cepheid Full time

    At Cepheid, we are committed to delivering fast, accurate diagnostic testing solutions that improve patient outcomes across the globe. As a member of our EHS team, you will play a critical role in ensuring the safety and well-being of our associates, customers, and the environment. We are seeking an experienced EHS Manager to lead and manage a team of EHS...