Senior Manager, Metrology

Job Summary

The Senior Manager, Metrology provides strategic and operational leadership for the site calibration and metrology program at Bora Biologics. This role is accountable for establishing, maintaining, and continuously improving a compliant, reliable, and efficient calibration program supporting manufacturing equipment, laboratory instrumentation, and utility systems. The position serves as the business and system owner for BMRAM and ensures calibration activities and associated records meet cGMP, quality, safety, and applicable regulatory requirements. The Senior Manager provides leadership and technical oversight for calibration employees and contractors and ensures appropriate staffing, training, scheduling, and performance of the function. The role provides oversight of instrumentation lifecycle activities and partners with equipment owners to maintain the compliant state of calibrated assets. This position collaborates closely with Facilities, Engineering, Quality, Manufacturing, and other stakeholders to ensure instrumentation reliability and support site operational objectives.

Essential Functions

• Provide leadership and technical oversight of the site calibration program, establishing standards, procedures, and best practices to ensure calibration activities are performed in accordance with cGMP requirements, approved procedures, quality standards, and applicable regulatory requirements.
• Manage, motivate, and mentor calibration staff; organize and prioritize workload, ensure appropriate training, promote teamwork, and drive achievement of productivity goals and continuous improvement.
• Serve as business and system owner for BMRAM, ensuring data integrity, timely and accurate entry of calibration records, appropriate management and notification of Out of Tolerance conditions, approval of calibration activities, monitoring and reporting of due and overdue activities, and ongoing system administration in partnership with IT.
• Coordinate and schedule calibration and preventive maintenance activities for manufacturing equipment, laboratory instrumentation, and utility systems.
• Provide technical and operational oversight of calibration contractors and service providers, ensuring personnel are appropriately qualified and work is performed in accordance with approved procedures, quality requirements, contractual expectations, and established budgets.
• Support procurement, setup, and lifecycle management of instrumentation and partner with internal instrument owners to ensure Equipment/Instrument Master Files are generated and maintained.
• Lead the investigation and resolution of complex calibration and instrumentation issues, including cross-functional problems and Out of Tolerance conditions, and identify appropriate corrective and preventive actions to minimize recurrence and operational impact.
• Implement continuous improvement and operational excellence methods and tools to improve the efficiency and effectiveness of calibration operations.
• Collaborate effectively with Facilities, Engineering, Quality, Manufacturing, and other internal customers to ensure proper functionality of instrumentation and support projects, policies, and procedures.

Minimum Education, Experience & Skills

• High School Diploma or equivalent with a minimum of 12 years of progressively responsible experience in metrology, calibration, instrumentation, equipment maintenance, or a related technical discipline within a regulated environment, including at least 2 years of direct supervisory experience; OR a Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline with a minimum of 8 years of relevant experience, including at least 2 years of direct supervisory experience.
• Demonstrated knowledge of cGMP requirements and calibration/metrology principles and practices.
• Strong knowledge of applicable industry standards and guidance, including ISO standards, ISPE guidance, and applicable CFR requirements.
• Demonstrated experience developing and managing calibration schedules, priorities, and compliance metrics.
• Strong analytical, problem-solving, organizational, and decision-making skills.
• Effective written and verbal communication skills with the ability to communicate across technical, Quality, operational, and management functions.
• Demonstrated ability to lead employees, contractors, and consultants in a regulated, cross-functional environment.
• Ability to balance strategic leadership with a hands-on approach to complex calibration and instrumentation issues.
• Proficiency with Microsoft Office applications and computerized calibration/maintenance management systems such as BMRAM.
• Supervisory responsibility for the calibration group, including employees and contractors performing on-site calibration services.

Preferred Qualifications

• Understanding and knowledge of process equipment and clean utility systems used in biopharmaceutical manufacturing.
• Ability to effectively negotiate contracts, bids, and change orders with vendors or contractors for calibration services.
• General knowledge of instrumentation typically used in a biopharmaceutical manufacturing plant.
• Experience supporting regulatory inspections and internal or external audits related to calibration, metrology, instrumentation, or equipment maintenance programs.