Corporate Metrology Senior Manager

Role Summary

Corporate Metrology Senior Manager responsible for leading metrology operations, calibration programs, and CMMS-enabled maintenance and calibration processes within a regulated environment. Oversees a site metrology laboratory, ensuring traceability to national/international standards and alignment with global calibration policies. Leads digital transformation, automation, and personnel development to drive metrology excellence.

Responsibilities

• Develop and implement strategic and tactical goals for the Metrology function aligned with global and site quality objectives.
• Drive standardization, harmonization, and continuous improvement across all metrology processes, systems, and calibration methods.
• Lead the site in the Global Metrology and Calibration Network; ensure global alignment on standards, policies, and technical practices.
• Lead CMMS transition projects and deliver calibration capabilities.
• Oversee daily metrology laboratory operations, ensuring timely and accurate calibration services across all measurement subject areas.
• Establish, validate, and maintain calibration intervals, tolerances, and environmental controls per internal and regulatory requirements.
• Manage calibration schedules and equipment lifecycle; implement preventive maintenance, repair, and replacement strategies.
• Maintain ISO/IEC 17025 compliance readiness and support audits.
• Establish and manage the metrology department budget.
• Collaborate with internal/external regulatory audits and represent the calibration program.
• Provide expert technical support to Manufacturing, Quality, Engineering, Process Development, and Facilities teams.
• Approve and review calibration deviations, out-of-tolerance conditions, and measurement uncertainty evaluations; implement CAPAs.
• Develop, review, and maintain SOPs, Work Instructions, and Calibration Job Plans.
• Ensure calibration data integrity and ALCOA+ compliance.
• Oversee implementation and maintenance of computerized calibration management systems (e.g., Maximo, SAP EAM).
• Ensure secure data management, system validation, and electronic record compliance per 21 CFR Part 11 and GAMP5.
• Drive digital transformation through automated test systems, remote monitoring, and electronic documentation workflows.
• Supervise, coach, and develop Metrologists and Calibration Technicians; establish development plans and cross-training.
• Manage performance reviews, workload distribution, and resource planning for staff and contractors.
• Own calibration training program for Amgen.
• Foster a safety-first culture with emphasis on precision, quality, and compliance.
• Manage relationships with calibration service providers, test equipment manufacturers, and external laboratories.
• Evaluate and qualify vendors to ensure traceability to standards (e.g., NIST).
• Oversee procurement and budgeting for calibration and test equipment.

Qualifications

• Basic Qualifications:
  • Doctorate degree with 2 years in Engineering, Physics, or related field; or equivalent experience
  • Master‚Äôs degree with 4 years in Engineering, Physics, or related field; or equivalent experience
  • Bachelor‚Äôs degree with 6 years in Engineering, Physics, or related field; or equivalent experience
  • Associate‚Äôs degree with 10 years in Engineering, Physics, or related field; or equivalent experience
  • High school diploma/GED with 12 years in Engineering, Physics, or related field; or equivalent experience
• Preferred Qualifications:
  • 8‚Äì10 years of metrology operations experience in a regulated environment (biotech/pharma/aerospace)
  • Experience in ISO/IEC 17025 calibration laboratory
  • Advanced measurement principles, calibration uncertainty analysis, root cause investigations
  • Experience with automated calibration systems and calibration management databases
  • Expert knowledge of metrology principles, traceability, measurement uncertainty, and statistics
  • Understanding of FDA, GMP, ISO 9001, ISO/IEC 17025
  • Strong communication, project management, and leadership
  • Proficiency with calibration management software and Microsoft Office
  • Ability to interpret complex technical documentation and lead cross-functional problem solving

Skills

• Metrology and calibration management
• Regulatory compliance (FDA, GMP, ISO standards)
• CMMS systems (Maximo, SAP EAM)
• Data integrity and ALCOA+
• Process improvement and project leadership
• Vendor management and procurement
• Technical writing (SOPs, work instructions)
• Cross-functional collaboration

Education

• As specified in Basic Qualifications above

Additional Requirements

• Willingness to operate in regulated and non-regulated environments
• Ability to lead a team and manage budgets