Combination Product Service Operations Manager

Becton Dickinson Medical Devices•Temecula, CA

1d•Onsite

About The Position

BD is a leading global medical technology company dedicated to advancing health worldwide. This role, Combination Product Service Operations Manager, is crucial for leading an engineering technician team within an FDA-regulated testing environment. The manager will be responsible for ensuring data integrity, scientific soundness, and adherence to regulatory requirements across all laboratory activities. Key aspects of the role include overseeing operational systems, managing equipment qualification, and driving continuous improvements in service delivery. BD emphasizes a culture of on-site collaboration to foster innovation and problem-solving within the fast-paced healthcare industry.

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.

Nice To Haves

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

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.