Corporate Metrology Senior Manager

Role Summary

Corporate Metrology Senior Manager responsible for leading and overseeing the site metrology laboratory and the global calibration program. Manages CMMS-driven maintenance/calibration initiatives, audits readiness, and drives continuous improvement in metrology processes, ensuring traceability to national/international standards and compliance with regulatory requirements.

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 Amgen‚Äôs Global Metrology and Calibration Network; ensure global alignment on standards, policies, and technical practices.
• Lead CMMS transition project for SAP/EAM and deliver calibration capabilities.
• Oversee daily metrology laboratory operations, ensuring timely and accurate calibration services across all measurement subject areas.
• Ensure calibration intervals, tolerances, and environmental controls are established, validated, and maintained per internal and regulatory requirements.
• Manage calibration schedules and equipment lifecycle, ensuring preventive maintenance, repair, and replacement strategies are executed effectively.
• Maintain the laboratory‚Äôs ISO/IEC 17025 compliance readiness and support internal and external audits.
• Establish/manage metrology department budget.
• Collaborate with internal/external regulatory audits and represent calibration program.
• Provide expert technical support to Manufacturing, Quality, Engineering, Process Development, and Facilities teams for metrology-related activities.
• Approve and review calibration deviations, out-of-tolerance conditions, and measurement uncertainty evaluations; implement corrective/preventive actions.
• 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 metrology 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, and resource planning for direct and contract staff.
• 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 NIST or equivalent standards.
• Oversee procurement and budgeting for calibration and test equipment, ensuring optimal asset utilization.

Qualifications

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

Skills

• Metrology principles and calibration management
• Project management and leadership
• Regulatory compliance (FDA, GMP, ISO) and audits
• CMMS/SAP EAM/Maximo administration
• Data integrity and ALCOA+ compliance
• Vendor and asset management

Education

• Advanced degree in Engineering, Physics, or related technical field (as per qualifications above)

Additional Requirements

• Willingness to travel as needed for site support and audits
• Ability to work in regulated and non-regulated environments