Assurance & Compliance Manager

Contract type:
Full Time

Job Description

The core of the role will be to help us accomplish our mission to improve clinical research. As an Assurance & Compliance Manager you will be working in a very dynamic environment, which means that you must have a strong problem-solving ability, organization skills, and be proactive. You are excited by the prospect of rolling up your sleeves to tackle meaningful problems every day.

IOMED's approach

IOMED is a leading technology company in the field of healthcare data. It is made up of a united, dynamic, and flexible team, which, after several years of working together, is characterized by its agility, enjoyment of work, and rapport. Accordingly, we are looking for candidates with the desire to innovate, launch a relevant project, and grow with it, always enjoying teamwork and challenges, which are many, every day.As an employer, we offer equal opportunity. We want to grow our team with talented, dynamic people who want to make their mark in the field of AI, regardless of race, color, religion, national origin, gender, physical disability, or age.

Elevate your career and join our innovative team! Apply now to be a driving force in shaping the future

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What we expect you to do.

You will lead our Integrated Management System in the development and execution of strategy for Quality and Information Security Assurance programs across IOMED’s software and research products and services. You will be responsible for strengthening, further developing and executing the quality assurance program and management systems.  You will:

  • In partnership with other team leaders, define and drive the strategy to continuously improve the QMS and ISMS to support adherence to the applicable regulatory requirements and enhance the system utilizing a risk-based, fit-for-purpose approach.
  • Lead teams, and develop programs that support the management infrastructure including document and training management; audit/inspections programs; CAPA management; metrics; and QA support to project teams/programs.
  • Develop and oversee the quality and information security system and key metrics of activities (e.g. document management, vendor compliance management, CAPAs, internal audits, etc.) to ensure it continuously meets
    regulatory and business requirements. Develop reporting tools and metrics for communication to senior leadership.
  • Develop and lead implementation of risk-based fit-for purpose Quality Assurance (QA) activities focused on risk assessment; issue identification, escalation, management; and corrective/preventive action (CAPA) management, and continuous improvement.
  • Serve as a senior quality consultant/advisor to teams and leadership providing quality advice regarding topics such as: interpretation of applicable regulatory requirements; research best practices; document management; process development/improvement; audit and inspection readiness; and risk management.
  • Lead external audit/regulatory authority inspection program, including liaising with clients, hosting on-site visits, and internal facilitation/oversight of associated action plans.
  • Lead the relationship with our DPO to ensure that IOMED meets its legal obligations regarding data protection and people's privacy.
  • Develop and oversee the internal audit program focused on identifying gaps, risks and opportunity for improvement.
  • Coach, lead, and mentor direct reports and build a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
  • Foster a quality culture focused on meeting high quality, ethical and regulatory standards.

What we expect from you.

  • You have a Bachelor's Degree (preferred in a relevant area, e.g., healthcare, quality).
  • You have strong project management, organizational, and analytical skills.
  • You have Good x Practice (GxP) subject matter expertise, preferably in Clinical or Pharmacoepidemiology.
  • You have direct experience planning, conducting, and supporting internal audits, external audits, and health authority inspections.
  • You have substantial experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs).
  • You have excellent verbal and written communication skills with demonstrated success working cross-functionally.
  • You have a problem solving mindset and demonstrated ability to deliver results; ability to distill complex issues and translate them into concrete action plans.
  • You have prior experience with root cause analysis, risk assessment, quality metrics, and corrective actions.

Nice to have.

  • You are comfortable working with remote teams and operating in a fast-paced, growing technology environment.
  • You have experience in achieving ISO certification.
  • You have experience with or an understanding of scientific methodologies or statistics.
  • You have experience with clinical research, especially in the community oncology or clinical trials network setting.
  • You have experience in epidemiological or outcomes research (real-world evidence)
  • You have familiarity with data generated from EMR/EHR.

What can we offer?

  • Competitive salary.
  • Permanent contract.
  • Company profit-sharing scheme valued at up to €15,000 per year. 
  • Flexible remuneration with restaurant tickets, transport tickets, nursery, training, and medical insurance.
  • Flexible schedule and hybrid working model.
  • 28 days of vacations per year.
  • A warm, transparent and supportive team, with a huge emphasis on work-life balance. 
  • The opportunity to make your mark in e-health and AI.

What we do.

Our Healthcare Data Activation technology unlocks data from both structured and unstructured sources, including human-written records, thanks to our Natural Language Processing System. This data is standardized into OMOP Common Data Model, and never leaves hospitals' in-house systems, thanks to our Federated Data Model , enabling healthcare organizations to have activated and readily usable data while maintaining its protection and security.

Interested in this position?