Combination Product Service Operations Manager

Bdjobs

Temecula, CA, USA
Base: $126,600.00 - $208,900.00 usd annual; bonus/...
**
Fda-regulated testing environments
Good manufacturing practices gmp
21 cfr part 11 compliance
** The Combination Product Service Operations Manager position at BD in Temecula, CA, is a remote role focused on managing laboratory operations within a regulated environment. The ideal candidate will have a strong background in operations management, particularly in FDA-regulated testing environments, and will lead a technical team to ensure compliance and operational excellence. **

Job Summary

  • This role involves leading the engineering technician team while serving as the senior technical escalation point for execution issues in a global medical technology company.
  • The position requires ensuring all laboratory activities maintain data integrity and adhere to approved protocols, SOPs, and strict regulatory requirements including FDA standards.
  • BD prioritizes on-site collaboration with a minimum requirement of 4 days per week in-office to foster creativity and effective problem-solving within the fast-paced healthcare industry.

Matching Summary

Match Score: 75

** The Combination Product Service Operations Manager position at BD in Temecula, CA, is a remote role focused on managing laboratory operations within a regulated environment. The ideal candidate will have a strong background in operations management, particularly in FDA-regulated testing environments, and will lead a technical team to ensure compliance and operational excellence. **

Salary

Base: $126,600.00 - $208,900.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture

Skills & Requirements

Must-have

  • FDA-regulated testing environments
  • Good Manufacturing Practices GMP
  • 21 CFR Part 11 compliance
  • ISO 17025 standards
  • Laboratory equipment qualification IQ OQ PQ
  • Data integrity and scientific soundness
  • Standard Operating Procedure SOP development

Nice-to-have

  • Leading operational transformations
  • Strong decision-making in complex environments
  • Clear communication in escalated situations
  • Experience with LIMS implementation
  • High level of accountability and ownership

Key Requirements

  • Track record in operations management within FDA-regulated environments
  • Experience supervising laboratory operations and staff management
  • Comprehensive understanding of USP, ISO, and ASTM testing methodologies
  • Proven ability to develop and maintain technical documentation
  • Minimum 4 days in-office presence required

Work Rights

Not specified

Tailored Resume

Cover Letter