Corporate Metrology Senior Manager

Role Summary

Corporate Metrology Senior Manager responsible for leading metrology operations, calibration programs, and CMMS-enabled maintenance and calibration initiatives within a regulated biotech environment. Oversees the site metrology laboratory, ensures traceability to national/international standards, and drives continuous improvement and digital transformation across metrology processes.

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’s 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.
• Establish/maintain calibration intervals, tolerances, and environmental controls per internal and regulatory requirements.
• Manage calibration schedules and equipment lifecycle; ensure preventive maintenance, repair, and replacement strategies are executed effectively.
• Maintain ISO/IEC 17025 compliance readiness and support audits.
• Budget metrology department operations.
• Collaborate with regulatory audits; 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 data integrity per ALCOA+.
• Oversee implementation and maintenance of computerized calibration management systems; ensure 21 CFR Part 11 and GAMP5 compliance.
• 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 distribution, and resource planning; own calibration training program.
• Foster safety and compliance culture in the metrology team.
• Manage relationships with calibration service providers and vendors; ensure traceability to standards (NIST or equivalent).
• Oversee procurement and budgeting for calibration and test equipment; optimize asset utilization.

Qualifications

• Basic Qualifications: Doctorate with 2 years in Engineering/Physics or related field; or Master’s with 4 years; or Bachelor’s with 6 years; or Associate’s with 10 years; or high school with 12 years of related experience (equivalents accepted).
• Preferred Qualifications: 8–10 years metrology operations in a regulated environment; ISO/IEC 17025 experience; advanced measurement principles and uncertainty analysis; automated calibration systems experience; strong knowledge of metrology principles, traceability, and statistics; familiarity with FDA, GMP, ISO 9001, ISO/IEC 17025; excellent communication and leadership; proficiency with calibration software and MS Office; ability to interpret complex technical documents and lead cross-functional problem-solving.

Skills

• Metrology principles and calibration management
• Regulatory compliance (FDA, GMP, ISO standards)
• CMMS (Maximo, EAM) configuration and administration
• SOPs, Work Instructions, calibration job planning
• Data integrity and ALCOA+ compliance
• Project management and leadership
• Vendor management and procurement
• Digital transformation and automation in metrology

Education

• Relevant advanced degree as listed in Basic Qualifications (Doctorate/Master/Bachelor/Associate) or significant equivalent experience.

Additional Requirements

• Travel requirements or physical demands are not specified as essential in provided content.