Job Description

Join our dynamic IT team as a Computerized System Validation Lead and drive compliance excellence in a collaborative environment! In this key role, you’ll lead compliance initiatives, represent us during audits, and engage with international partners to innovate and enhance productivity. If you’re passionate about regulatory standards and ready to tackle new challenges, we want you on board! Your expertise will be vital in shaping the future of our compliance programs.

Apply now and embark on an exciting journey where your contributions will make a real difference!

Welcome to the team

Our IT team operates as a Business Partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. In this young and growing team, you will report into the Director of Compliance EMEA.
 

Purpose of the role
Computerized System Validation Lead is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities.

Primary Responsibilities:

Lead and support site functional and cross-functional teams to ensure compliance with computerized system validation and IT/OT regulations.Act as the primary representative for compliance activities during audits by internal and external auditors and regulatory agencies, ensuring all findings and documentation meet required standards.Collaborate with local quality organizations to develop audit responses and strategies for addressing compliance issues as they arise.Identify IT/OT compliance risks and engage in remediation efforts, ensuring that risks are effectively managed and mitigated.Conduct risk assessments to evaluate the compliance implications of new technologies and significant changes to existing systems, providing recommendations for improvement as needed.Report on challenges regarding procedural nonconformance and the status of local/site-based deviations, CAPAs, and quality records, while communicating changes to SDLC policies and championing best practices across the organization.

Your profile

Bachelor’s degree in computer science, engineering, regulatory compliance, or a closely related field is required.Minimum of 3-5 years of experience supporting compliance activities, demonstrating a strong background in regulatory environments, includingProficient knowledge of regulatory requirements applicable to computerized systems validation and compliance, including but not limited to 21 CFR Part 11 and EMEA Annex 11 and familiarity with ISA S95 and S88 standards in a Good Practice (GxP) environment, showcasing an understanding of industry standards and practices.Knowledge of validating and qualifying Cloud, SaaS, and data integration architecture platforms, along with a strong understanding of end-to-end manufacturing processes, including quality and supply chain.Excellent written and verbal communication skills in English and Dutch, capable of conveying complex concepts in an easily understandable manner to diverse audiences.Demonstrated ability to partner with various stakeholders, effectively navigating conflicting priorities to achieve both tactical and strategic goals.Proven ability to develop and implement effective plans and strategies, with a strong focus on achieving results.

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 below will give you an idea of what you can expect.

Competitive salary and a 3% year-end allowance;35,5 days of leave;Attractive collective health care insurance package with considerable reduction rates;Solid Pension Plan;Annual bonus based on own and company performance;Travel allowance for commuting;Numerous training, coaching and e-learning modules for long term job opportunities and development

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/7/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R332605