Manufacturing System Manager

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At KVALITO Consulting, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.

At KVALITO, we embrace diversity, equity, and inclusion in every aspect of our work, fostering a results-oriented, ambitious, and caring culture. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Together, we champion a culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.

If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.

KVALITO Life Science Consultant, IT System Manager

Location: Johor, Malaysia (On-site)

Mission:

We are seeking a skilled MS&T System Manager to oversee the alignment of technology systems with the scientific and technical needs of manufacturing operations. This role emphasizes optimization and integration of systems to support process development, technical transfers, and manufacturing performance enhancement within the pharmaceutical and biotechnology sectors. The ideal candidate will bridge the gap between IT systems and MS&T functions, ensuring seamless support for manufacturing innovation, data integrity, and regulatory compliance.

Key Accountabilities:

1. System Integration and Support:
   1. Manage and maintain systems critical to process development and technical transfer activities.
   2. Optimize the integration of IT systems with manufacturing execution systems (MES), laboratory systems, and process monitoring tools.
   3. Oversee deployment and operation of software supporting process scale-up, validation activities, and manufacturing analytics.
2. Manufacturing Science and Technology Alignment:
   1. Partner with MS&T teams to identify system needs for ongoing process improvement and new technology adoption.
   2. Support technical transfer processes by ensuring system compatibility and effective data migration.
   3. Enhance data visualization and analytics capabilities to enable real-time insights into process performance.
3. Compliance and Governance:
   1. Ensure systems align with GxP standards, validation requirements, and pharmaceutical industry best practices.
   2. Implement robust data governance policies and promote adherence to regulatory guidelines (e.g., FDA, EMA).
   3. Oversee segregation of duties (SoD) frameworks to manage access and ensure compliance.
4. Project Management and Stakeholder Collaboration:
   1. Lead system-related projects, ensuring alignment with MS&T objectives and timely delivery.
   2. Act as the primary liaison between IT teams, MS&T groups, and external vendors to enhance system functionality.
   3. Provide training and support for teams leveraging these systems for process development and optimization.

Requirements:

1. Qualifications:
   1. Bachelor's degree in engineering, Pharmaceutical Science, Information Technology, or related fields.
   2. Advanced degrees in Process Engineering or Manufacturing Science are a plus.
2. Experience:
   1. 5+ years of experience in managing systems supporting MS&T or related functions in the pharmaceutical/biotech industry.
   2. Demonstrated experience in process optimization, technical transfer, and manufacturing systems integration.
   3. Familiarity with manufacturing technologies (e.g., MES, IoT, or PAT tools) and their integration into operational workflows.
3. Technical/Functional Skills:
   1. Expertise in managing enterprise-level systems (e.g., LIMS, MES, or ERP systems supporting MS&T).
   2. Strong understanding of data analysis tools for manufacturing performance (e.g., statistical process control).
   3. Experience ensuring compliance with GMP, FDA, and ISO regulations.
   4. Analytical mindset with the ability to optimize workflows and drive system innovations.

We offer great benefits:

• Flat hierarchies and responsibility from the beginning
• People-oriented culture
• Diversity and inclusion-focused environment
• Global client projects in a multinational environment
• Flexible working hours and home office
• Involvement in global conferences
• Individual professional development, training, and coaching