IT/OT Compliance Lead

Job Description

A fantastic opportunity has arisen for an IT/OT Compliance Lead.

The IT/OT Compliance Lead will provide compliance/validation support to an IT & Automation Team and the general site to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), QSIP, Cyber Security and Data Integrity for manufacture and supply of quality pharmaceutical products.

Bring energy, knowledge, innovation to carry out the following:

• Accountable for the effective and efficient running of all CSV/Compliance operations in the IT/Automation team.
• 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.
• Liaise with Compliance Leads from other sites and functions onsite.
• Support Site Quality Council and other site quality initiatives.
• Support IT/Automation Investigations, root-cause analysis and CAPA’s

What skills you will need:

In order to excel in this role, you will more than likely have:

• 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.
• Proficient 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 Manufacturing Systems as well as Cloud, SaaS, and data integration architecture platforms, along with a strong understanding of end-to-end manufacturing processes.
• Excellent written and verbal communication skills in English, 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.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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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. 

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