Operational Technologies Compliance Lead

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Job Description

About the Role

Join our Operational Technologies Programs team! We lead the rollout of solutions that transform manufacturing across all our global sites. We act as business and/or system owners for key initiatives such as MES, UPI, LPMS, ePI/Pharmaledger, Nymi, and others—defining governance models and standardized, scalable processes that drive efficiency, ensure compliance, and enhance digital transformation. As the Operational Technologies Compliance Lead, you will provide strategic oversight and leadership for global quality processes related to OT systems. You will act as a subject matter expert in validation and compliance, driving the development and implementation of standardized strategies for testing, training, and governance. Your role will be pivotal in advancing Takeda's Industry 4.0 and digital transformation objectives, ensuring consistent governance and standards across all systems.

Our team is diverse and collaborative, combining deep subject matter expertise, strong program and project management skills, and cross-functional partnerships across global functions and site teams. We are motivated, engaged, and passionate about bringing innovation into our manufacturing environment—while consistently meeting regulatory requirements. That’s where your role comes in:

How You Will Contribute

• Lead the design, implementation, and oversight of compliance procedures and controls for OT systems within Global Engineering, aligning with Takeda's QMS and global regulatory standards.

• Serve as the Compliance Lead for OT systems, such as MES, serialization, track & trace, and authentication anti-counterfeiting, ensuring governance and compliance across manufacturing sites.

• Partner with Global Engineering's System and Business Process Owners to establish standardized frameworks for compliant deployment of manufacturing and OT systems.

• Develop and maintain global test and validation strategies aligned with Takeda's Global Quality Policies.

• Ensure global availability and readiness of quality-compliant documentation and guidance for site-level system rollouts.

• Act as the Data Integrity lead for Global Engineering, ensuring consistent application of governance structures and standards.

• Drive continuous improvement and innovation in OT compliance through digital tools, automated testing, and paperless validation solutions.

What You Bring to Takeda

• A BA, BS, or MS in Chemical/Mechanical/Software Engineering, Natural Sciences, Biotechnology, Pharmacy or related areas

• Completion of relevant Quality Assurance education and courses, direct experience in Quality Assurance would be an advantage.

• At least 8 years of experience in a pharmaceutical, biotechnology, medical device, or related environment.

• In-depth knowledge of pharmaceutical production and shop-floor operations.

• Familiarity with best practices such as GAMP/5 and Software Testing as per IEEE standards.

• Ability to collaborate with stakeholders across multiple levels in the company and all across the GMS/GQ manufacturing network.

• Solid presentation and strong analytical and communication skills.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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