Manager, Risk Analyst BIRO EIT

Job Description

Manager, Risk Analyst BIRO EIT

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 companys’ 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

Information Technology Risk Management and Security (ITRMS) is an essential component of our IT strategy. ITRMS supports IT organizations, Pharmaceutical Research, Animal Health (AH), Supply Chain, Manufacturing and Marketing.

Our quality and compliance team is embedded in the Business Information Risk Organization structure (BIRO) and provides System Development LifeCycle (SDLC), validation and quality oversight to several global systems, to ensure these are inspection ready and their use confirms with the Health Authorities expectations. 

Our team plays a key quality and IT compliance role in support of the main critical global enterprise systems.

We partner with Business and Technical representatives to gather objective evidence that the software, hardware, equipment and operating procedures, work consistently as per Business need, conforms with Health Authorities expectations, ensuring compliance and patient safety.    

What will you do in this role:

• Partnering with relevant Business and Technical representatives to gather objective evidence that software, hardware, equipment, operating procedures, and operational environment are meeting Business needs and Regulatory expectations.
• Capacity to work independently or in collaboration with Business and Technical representatives to assess and resolve any compliance issue may result as part of a system release or during the daily system governance.
• Supporting the weekly change management bundles in alignment with the given timelines. In addition, review and approve each assigned change request for the supported systems.
• Executes, monitors and completes quality review and approval of SDLC documentation (Plans, Requirements, Specifications, Testing and Reports), in alignment with the project timelines in alignment with the quality standards.
• Provides timely review and pre/post approval of Acceptance Test cases as well as associated defects, if any.
• Ability to author validation deliverables such as Validation Plans, Validation Protocols, Validation Reports.
• Works with the Service Line Lead to identify opportunities for improvements within the assigned Service area.
• Conducts analysis of any change in the existing policies and impacted procedures, as a results of a change in the regulatory / health authorities expectations and assess the impacts of the current ways of working by adapting the associated documentation and operational procedures.
• Provides compliance support and guidance on the Company System Development LifeCycle and associated Operational Procedures, in any phase / stage of the project. This includes the operation phase.
• Drive, support, and manage quality compliance issues that may emerge during various SDLC phases of IT projects. This requires effective communication and a proactive approach in resolving potential challenges
• Weekend work might be required in support of IT system release.

What Should you have:

• A minimum of three years of relevant experience in similar roles within the pharmaceutical industry.
• Knowledge and comprehension of validation requirements pertaining he pharmaceutical sector. This includes familiarity with regulations from key health authorities such as the FDA, EMA, or others relevant to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP). Candidates should be able to articulate how these regulations impact product lifecycle and quality assurance processes.
• Solid understanding of risk management frameworks and methodologies. Candidates should possess the ability to identify potential risks in operational processes, evaluate their severity, prioritize them based on impact, and implement effective mitigation strategies. Familiarity with tools and techniques for risk analysis, such as FMEA (Failure Modes and Effects Analysis) or risk matrices, is advantageous.
• Experience in consistently adhering to company policies, standard operating procedures (SOPs), and regulatory guidelines. The candidate should demonstrate a thorough understanding of compliance requirements and be able to navigate complex compliance landscapes effectively
• Strong capability to make independent, informed decisions while prioritizing tasks in alignment with operational procedures. This includes the ability to assess situations quickly, weigh options, and take decisive action that supports business objectives while maintaining compliance.
• Knowledge of project management and testing tools, including but not limited to Jira/Xray, Application Lifecycle Management (ALM), and TOSCA. Experience with these tools should highlight the ability to track project progress, manage testing phases, and ensure quality control throughout the software development life cycle.
• Experience in supporting Health Authorities inspections represents a valuable asset.
• Competence in using common office software tools such as Microsoft Word, Microsoft Excel, Outlook and PowerPoint.
• Business-level proficiency in English, both written and verbal.
• Ability to engage and communicate effectively with team members and the different levels of the organization, from diverse cultural backgrounds. This includes understanding and respecting different communication styles, norms, and perspectives to foster a collaborative and inclusive team environment.
• High level of adaptability in a dynamic work setting. Ability to adjust communication and work approaches to accommodate varying time zones, cultural practices, and team structures, ensuring seamless collaboration across separated locations.

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. 

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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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