Global MSAT Tech & Network Standards Steward

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The Position

As an integral part of Pharma Technical Operations (PT), PT Global MSAT, Engineering and Sustainability (PTT) plays a key role in leading a seamless industrialization and thorough technical product management through integrating SHE, proactive maintenance, facility fitness, performance optimization and scalable manufacturing processes and technologies in support of the manufacturing network. Product and process robustness, efficiency and reliability are key performance indicators, PTT owns and drives continuous improvement.
We are looking for a technical expert who understands the realities of the manufacturing areas and can design standard operating frameworks that drive operational excellence and compliance. 

The Opportunity

In this role you proactively identify and close quality systems gaps across the network and you serve as translator between shop-floor manufacturing realities and global quality standards, ensuring that compliance frameworks enable manufacturing throughput and continuous improvement.More responsibilities include: 

• Support manufacturing sites and global networks in proactively identifying and close quality systems gaps, implementing standardized processes and quality standards 

• Drive the delivery and sustainment of a robust and regulatory-compliant Quality Management System (QMS) process as global single point of contact and core decision-maker for the assigned global quality system process content and design

• Translate HA requirements into an implementable QMS process, collaborating closely with independent quality compliance partners, staying updated on evolving regulations, health authority expectations, and external industry benchmarks to drive continuous optimization of the Quality Management System (QMS)

• Oversees the timely execution of critical deliverables, including global policy updates, IT/digital tool enhancements (e.g., Veeva), training deployment, and performance metric tracking for the assigned global quality system process .

• Provide expert guidance and direct support for regulatory inspections and health authority audits relating to global quality system processes.

• Manage intersections with other quality system process owners to achieve seamless, end-to-end process management across cross-functional squads and technical governance forums.

Who you are

You are a specialized expert in manufacturing technologies and compliance with a strong sense of accountability and exceptional strategic decision-making capabilities. Your qualifications include: 

• Bachelor's or Master’s Degree in Chemical Engineering, Biochemical Engineering, or the Life Science with 7 + years or more of relevant industrial experience in parenteral production (compounding to Visual inspection) within quality systems, quality operations, or pharmaceutical manufacturing. 

• Strong Knowledge in stability management through out distribution is a plus

• Specialized knowledge of pharmaceutical quality systems and industry-wide guidelines relevant to pharma process development and manufacturing, such as ICH guidelines.

• Strong digital acumen and experience supporting IT-solutions or quality management platforms, such as Veeva, is highly preferred.

• High degree of problem-solving skills and the ability to gain alignment with internal stakeholders and authorities in operationally demanding environments. You are a collaborative leader who excels in providing clear guidance to matrix teams while maintaining a focus on implementation, compliance, and reliability through the QMS process lifecycle

<10% travel required

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.