Combination Product Service Operations Manager

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities:

• Lead the engineering technician team with comprehensive workload management while serving as the senior technical escalation point for execution issues. Ensure all laboratory activities maintain data integrity and scientific soundness through proper technical oversight and quality control measures.
• Ensure all services adhere to approved protocols, SOPs, and regulatory requirements. Take decisive action including reprioritization or work stoppage when quality, compliance, or safety is at risk. Collaborate with Quality team on investigations related to deviations, non-conformances, and CAPAs.
• Own the effectiveness and integrity of operational systems supporting laboratory service delivery, including LIMS implementation and workflow optimization. Maintain accountability for end-to-end operational workflows from sample intake through data reporting while ensuring alignment between processes, quality requirements, and system configuration.
• Lead IQ/OQ/PQ activities for laboratory equipment, ensuring operational readiness and fitness-for-use. Develop equipment qualification strategies aligned with service requirements and regulatory expectations while maintaining appropriate documentation and change control procedures.
• Set clear performance expectations for the engineering team while supporting their ongoing development. Use data-driven metrics to inform decision-making and implement operational improvements that enhance service delivery, scalability, and client satisfaction.

Minimum Requirements:

• Demonstrated track record in operations management within FDA-regulated testing environments (pharmaceutical, medical device, or food industries), with specific experience implementing and maintaining compliance systems that meet regulatory standards and successfully navigating audits.
• Previous experience supervising laboratory operations, including staff management, equipment maintenance programs, inventory control systems, and implementing efficiency improvements while maintaining quality standards in a regulated testing environment.
• Comprehensive understanding of Good Manufacturing Practices (GMP) and FDA-regulated laboratory operations, including familiarity with 21 CFR Part 11, Part 210/211, and quality management systems that ensure data integrity and regulatory compliance.
• Working knowledge of industry standards such as USP (United States Pharmacopeia), ISO (particularly ISO 17025 for testing laboratories), and ASTM testing methodologies, with experience applying these standards to laboratory processes and validation activities.
• Proven ability to develop, review and maintain technical documentation including Standard Operating Procedures (SOPs), test protocols, validation reports (IQ/OQ/PQ), change control documentation, and other quality system records that meet regulatory requirements.

Preferred Requirements:

• Experience leading or supporting operational transformations, system implementations, or process‑maturity initiatives in regulated environments
• Proven leadership of technical teams through periods of change
• Strong decision‑making skills in complex, evolving operational environments
• Clear communication skills, particularly in escalated situations
• High level of accountability and ownership