Manufacturing Change Control Manager

Role and Responsibilities

Own and lead the manufacturing change control system, ensuring compliance with documentation standards, Quality systems, and regulatory requirements, along with stated ISO9001:2015 procedures.

Establish and maintain clear governance for change initiation, impact assessment, approval, implementation, effectiveness checks, and closure.

Serve as the subject matter expert (SME) for change control processes during internal and external audits.

Partner with Manufacturing Operations, Quality, Engineering, Supply Chain, Regulatory, and Technical Operations to schedule deviation runs in production, confirm operator training and line readiness before execution.

Facilitate change control boards (CCBs) or similar governance forums as applicable to the manufacturing process.

Interpret Bill of Material (BOM) changes and documentation updates: ensure BOMs, drawings, specs, routings, work instructions, and quality documents are updated, released, and version-controlled before use.

Compliance & Audit Support

Ensure change control documentation meets regulatory expectations (ISO9001:2015 and Internal Standards as applicable).

Lead responses to audit observations related to change control and manufacturing changes.

Proactively identify compliance gaps and implement corrective and preventive actions (CAPAs).

Continuous Improvement

Analyze change control metrics (cycle time, overdue actions, rework, repeat changes).

Drive process improvements to improve efficiency without compromising compliance.

Implement best practices, digital tools, or harmonized workflows across sites where applicable.

Support for automation and dashboarding development to improve communication to senior leadership.

People Management & Development

Lead, mentor, and develop change control and operations professionals.

Set clear performance objectives and foster a culture of accountability, quality, and continuous improvement.

Support succession planning and capability building within the team.

Strategic Contribution

Provide input to manufacturing and quality strategy related to lifecycle management and operational readiness through coordination of kaizen events.

Plan and coordinate engineering change implementation in production: cut-in/cut-over strategy, effective dates, line trials, operator training, tooling/fixture updates, workflow routings, work instructions, and inspection plans.

Material Optimization

Manage material disposition: define and execute use-as-is/rework/scrap/return strategy for WIP, finished goods, incoming and on hand inventory; coordinate labeling/segregation of material to prevent mix-ups.