Job Summary

The Senior Manager, Quality Control & Calibration provides strategic leadership for the Quality Control function in Elkton and the Calibration function supporting manufacturing, laboratory, and distribution operations and other select TMC sites. This role is responsible for ensuring sustained compliance with applicable regulatory requirements, the Terumo Quality System, and corporate policies while maintaining effective quality oversight, equipment reliability, and operational performance.

As a member of the Elkton site quality leadership team, the Senior Manager establishes organizational priorities, develops departmental capabilities, and drives continuous improvement through cross-functional collaboration with Manufacturing, Engineering, Operations Quality, Supply Chain, Laboratory, and business leadership. The position is accountable for the overall effectiveness of Quality Control and Calibration systems, processes, personnel, and resources, ensuring inspection readiness, risk management, product quality, and alignment with site and business objectives.

Job Details/Responsibilities

General
Lead and develop Quality Control and Calibration organizations through effective talent management, organizational planning, succession planning, performance management, and employee development initiatives
• Lead and develop the Quality Control and Calibration organizations through talent development, performance management, succession planning, and organizational effectiveness initiatives
• Establish departmental strategy, objectives, budgets, and resource plans aligned with site and business priorities
• Partner with Manufacturing, Engineering, Quality, Laboratory, and Operations leaders to drive operational excellence, quality performance, and continuous improvement
• Monitor operational, quality, compliance, and financial performance metrics to guide decision-making and support achievement of business objectives.
• Lead, coach, and develop people managers and quality professionals to build organizational capability and succession readiness

Compliance
• Ensure sustained adherence to applicable regulatory requirements, the Terumo Quality System, and corporate policies
• Establish and continuously improve policies, procedures, and governance processes that maintain inspection readiness and compliant operations
• Support audits, management reviews, change management, NC/CAPA processes, and compliance risk mitigation activities
• Direct regulatory inspection readiness efforts for QC and Calibration functions and ensure timely, effective resolution of compliance issues and quality system gaps

QC Function
• Provide strategic and operational leadership for Elkton Quality Control activities supporting incoming inspection, in-process inspection, other product appraisal, and final product release testing
• Ensure effective Quality Control systems, processes, and organizational capabilities that support compliant and efficient manufacturing operations
• Oversee Quality Control support of MES and other quality-related systems to ensure data integrity, compliance, and operational effectiveness
• Lead identification, investigation, and resolution of quality risks, nonconformance trends, and systemic issues while advancing continuous improvement initiatives and new quality technologies.

Calibration Function
• Provide strategic leadership and governance for the Elkton site and other TMC entities' Calibration Programs, ensuring compliance, equipment reliability, and operational effectiveness
• Direct calibration systems, schedules, standards, records, vendors, and service providers to ensure effective lifecycle management of measuring and test equipment
• Lead calibration support for equipment qualification, validation, capital projects, facility changes, and manufacturing operations
• Drive continuous improvement through calibration metrics, statistical analysis, reliability assessments, and investigation of out-of-tolerance conditions and equipment-related risks.

Knowledge, Skills and Abilities (KSA)

Leadership, Management & Collaboration
• Demonstrated ability to lead and develop Quality Control and Calibration organizations, including talent development, succession planning, organizational effectiveness, and change management.
• Proven ability to establish strategy, align resources to business objectives, and drive operational excellence through cross-functional leadership.
• Strong communication, influence, and relationship-building skills with the ability to engage senior leadership, build alignment, and drive results across Manufacturing, Engineering, Quality, Laboratory, Supply Chain, and other business functions.

Quality, Regulatory & Technical Expertise
• Advanced knowledge of quality systems, cGMPs, FDA regulations, ISO standards, and calibration-related requirements within a regulated manufacturing environment.
• Expertise in quality system processes, including audits, inspections, CAPA, nonconformance management, change control, and regulatory compliance.
• Strong knowledge of Quality Control operations, calibration systems, metrology principles, equipment lifecycle management, and manufacturing support processes.

Business Acumen & Problem Solving
• Strong analytical and risk management capabilities, including application of metrics, statistical methods, and trend analysis to support decision-making.
• Ability to balance compliance, quality, operational, and business requirements while delivering sustainable results.
• Experience identifying and implementing process, system, and technology improvements that enhance organizational performance.

Qualifications/ Background Experiences

Leadership, Management & Collaboration
• Demonstrated ability to lead and develop Quality Control and Calibration organizations, including talent development, succession planning, organizational effectiveness, and change management.
• Proven ability to establish strategy, align resources to business objectives, and drive operational excellence through cross-functional leadership.
• Strong communication, influence, and relationship-building skills with the ability to engage senior leadership, build alignment, and drive results across Manufacturing, Engineering, Quality, Laboratory, Supply Chain, and other business functions.

Quality, Regulatory & Technical Expertise
• Advanced knowledge of quality systems, cGMPs, FDA regulations, ISO standards, and calibration-related requirements within a regulated manufacturing environment.
• Expertise in quality system processes, including audits, inspections, CAPA, nonconformance management, change control, and regulatory compliance.
• Strong knowledge of Quality Control operations, calibration systems, metrology principles, equipment lifecycle management, and manufacturing support processes.

Business Acumen & Problem Solving
• Strong analytical and risk management capabilities, including application of metrics, statistical methods, and trend analysis to support decision-making.
• Ability to balance compliance, quality, operational, and business requirements while delivering sustainable results.
• Experience identifying and implementing process, system, and technology improvements that enhance organizational performance.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay: $144,200 - $202,180/year.