IT Compliance & Risk Management
Merck Sharp & Dohme Corp
Haarlem, NH, NL
7 dagen geleden

COM000560

Do you enjoy working in an international environment with lots of room for personal development? Did you always want to work in a company where your work can have a real impact on people’s life?

We have an exciting opportunity for a Senior Specialist IT Compliance & Risk Management.

The primary focus for this role will be IT incidents & deviation investigations. It includes leading investigators to develop and manage IT Compliance Investigation Reports (CIRs), IT Quality Variances, and the associated CAPA, which includes supporting determination of compliance impact on the business, leading the development of root cause and Corrective and Preventative Actions (CAPAs) planning across IT.

As such, second level support to external Inspections / QA audits will be provided.

Main responsibilities

  • Lead the ITCIR and CAPA as well as IT Quality Variance processes in collaboration with IT divisional business and technical owners and regulatory areas.
  • Partner with the IT Incident, Problem Management, Operational and Delivery teams as well as Divisional Quality and Regulatory teams in support of investigations in order to ensure the overall compliance posture of Global IT system is resilient and sustained.
  • Proactively collaborate with other ITRMS, IT, Compliance, and Quality organizations, as well as a broad client base to break-
  • down organizational boundaries in favor of a highly collaborative culture which focuses on the investigation of identified risks and compliance issues.

  • Possess strong knowledge of company policies, procedures, SDLC and standards as well as work collaboratively with the policy owners and teams to assess deviations and compliance impact.
  • Author, and track to completion, IT systems incidents with a potential or definitive compliance impact that have an impact on the business.
  • Develop risk-based processes to provide second level support for IT GxP inspections (where GxP could be Good Laboratory Practices GLP Good Clinical Practices GCP , Good Manufacturing Practices GMP , Good Distribution Practice GDP or Good Clinical Data Management Practices GCDMP ) for above-site systems.
  • Manage, in a timely matter Inspection support requests, Compliance Investigation Reporting, and Quality Variance investigation results and related risks to business and communicate and raise awareness about critical GxP inspection and QA audit risks, trends and emerging themes.
  • Welcome in our team

    The ITRMS department is part of the global IT Risk Management and Security (ITRMS) organization. The team consists of several colleagues, who interact with business as leaders of Global IT Incident / Compliance Investigation Report (CIR) and IT Quality Variances processes for computerized systems as well as second level support for Global IT Systems Inspection Readiness.

    The Team closely collaborates with global & regional IT Teams as well a Quality & Regulatory Teams.

    Your profile

  • Bachelor's- or Master's degree in a science or technology discipline
  • 7 years required experience in Quality, Regulatory, IT, or GxP / non-GxP Operations, with preferably 5 years of experience in IT compliance, quality or a regulatory area
  • Possess strong root cause analysis investigation skills.
  • Possess strong problem-solving skills, knowledge of GxP, technical writing, data management collection and analysis
  • Demonstrated interpersonal skills including flexibility and ability to work in a team environment
  • Innovative, analytical and inquisitive mindset : demonstrate the ability to adapt current work processes to meet emerging needs and changes in job responsibilities.
  • Good administrative skills and the ability to work a strongly regulated environment.
  • Ability to lead, support, and influence enterprise change initiatives
  • What we offer

    We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development.

    Our benefits are very competitive and the summary (NL based reference) below will give you an idea of what you can expect.

  • Competitive salary and a 3% year-end bonus;
  • 35,5 days of leave;
  • Attractive collective health care insurance package with considerable reduction rates;
  • Solid Pension Plan;
  • MSD Incentive Plan;
  • Travel allowance for commuting;
  • Free in-house sport facilities
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.
  • Information

    For more information on this vacancy please contact : Harry Vuijk , Associate Director, Compliance & Risk Management, phone : +31 6514 951 96.

    Application

    If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English.

    About us

    MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

    Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.

    Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.

    To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

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