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Manager, Laboratory Operations Compliance

Manager, Laboratory Operations Compliance

ConfidentialHyderabad / Secunderabad, Telangana, India
5 days ago
Job description

Job Description

Manager-Technology Compliance

The Opportunity

  • Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
  • Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
  • Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers.

Role Overview

As a Technology Compliance Partner, you will be responsible for authoring SDLC documents and providing SDLC advice to IT colleagues regarding the practical application of the SDLC. This role is vital for IT product, engineering, and service teams to understand and implement technology and process controls to meet the company's policy and regulatory obligations. This role supports our Animal Health R&D laboratory locations in China, Singapore, Australia and New Zealand and coordinates together with the world-wide Lab Compliance team on priority.

What Will You Do In This Role

  • Engage with IT practitioners and acts as a consultant for the System Development Life Cycle (SDLC), Compliance Risk Profile, Digital SDLC, Good Documentation Practices and the IT Control Requirements Set including the adoption of agile ways of working.
  • Provide compliance advice to IT colleagues regarding the practical application of the SDLC for product teams.
  • Support efforts to reduce SDLC documentation through automation and pipeline delivery
  • Advance Agile SDLC competency and drive good practices for product teams
  • Work across product teams and initiatives as subject matter expert on the SDLC and IT compliance controls
  • Maintain a customer-centric focus on compliance to drive a consistent approach across IT
  • Write and review SDLC documentation according to our company's standards
  • Assist in collecting information for Change Control and addressing impact changes for application releases.
  • Ensures that the IT organization operates and complies with established policies / procedures.
  • Supports audit / inspection readiness and participates in the timely review and Corrective and Preventative Action (CAPA) response.
  • Monitors IT compliance indicators, evaluates impacts and ensures non-compliance incidents are communicated and actioned.
  • Oversees policies, SOPs, supporting documents and associated materials to ensure seamless integration with other processes.
  • Work within a matrix organizational structure, reporting to both the functional manager and the project manager.
  • What Should You Have

  • Bachelor's degree in computer science, Information Technology, Law, or a related field.
  • 3+ years of experience in technology compliance, risk management, or a related field.
  • Strong knowledge of data protection laws and regulations (e.g., GDPR, OECD nr 17 (GLP CSV), Annex 11).
  • Understanding of System Development Life Cycle, good engineering practice, and computer validation
  • Excellent analytical and problem-solving skills.
  • Excellent verbal and written communication skills to convey risk findings and recommendations.
  • Ability to communicate complex compliance issues to non-technical stakeholders.
  • Meticulous attention to detail to ensure accurate risk assessments and reporting.
  • Understanding of relevant regulations and compliance standards.
  • Ability to manage risk-related projects and coordinate with various teams.
  • Strong organizational skills to handle multiple tasks and priorities effectively.
  • Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation.

    Who We Are

    We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    What We Look For

    Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

    #HYDIT2025

    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

    Regular

    Relocation

    VISA Sponsorship

    Travel Requirements

    Flexible Work Arrangements

    Hybrid

    Shift

    Valid Driving License

    Hazardous Material(s)

    Required Skills

    Audit Management, Governance Management, Quality Assurance (QA), Quality Management, Risk Management, Technical Advice

    Preferred Skills

    Job Posting End Date

    10 / 22 / 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 R346591

    Skills Required

    audit management, Sdlc, Agile, Risk Management, Change Control, Quality Management

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    Manager Compliance • Hyderabad / Secunderabad, Telangana, India

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