Senior QMS Director - Remote, Multi-Site

cGMP Consulting Inc.; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

cGMP Consulting is seeking a senior quality leader to build and scale a comprehensive Quality Management System (QMS) across government warehouse, distribution, and regulated logistics operations. This role emphasizes autonomy, site leadership, and strategic quality program development in a fast-paced GMP setting.

The ideal candidate will lead multi-site quality programs, drive investigations and CAPA, and present quality risks to executives, auditors, and government stakeholders.

Qualifications

• Bachelor’s degree or equivalent in Quality Management, Supply Chain, Logistics, Engineering, Life Sciences, Business or related field.
• 8+ years of progressively responsible experience in quality assurance, quality systems, regulatory compliance, supplier quality, distribution quality, or operational quality.
• 3+ years of experience managing personnel or leading a quality function, program, or multi-site quality initiative.
• Experience designing, implementing, and continuously improving QMS, including audits, investigations, CAPA, change control, document control, training, quality metrics, and ISO 9001-aligned practices.
• Experience leading quality programs in warehouse, distribution, logistics, cold-chain, or temperature-controlled operations under cGMP-regulated environments.
• Experience with temperature mapping, equipment qualification, calibration, environmental monitoring, alarm management, and temperature-excursion investigations.
• Experience supporting supplier quality, operational change control, system validation, and quality assessments of process, equipment, or technology changes.
• Strong executive communication, presentation, and stakeholder-management skills, with sound judgment and the ability to drive issues through resolution.
• Ability to obtain and maintain the security clearance required for supported programs.
• Must be a U.S. citizen and able to satisfy contract-specific citizenship, site-access, suitability, and background investigation requirements.
• Willingness and ability to travel up to 50%.

Responsibilities

• Build, implement, and continuously improve the QMS across government operations.
• Develop site and program quality plans aligned to requirements and risks.
• Develop quality metrics and management-review processes for visibility into performance and risks.
• Lead and develop site quality teams across multiple locations.
• Identify recurring issues and drive root-cause resolution and corrective actions.
• Establish quality controls across receiving, storage, inventory, fulfillment, shipping, and transportation.
• Oversee storage environments and related qualification, calibration, and monitoring.
• Lead investigations of deviations, nonconformances, temperature excursions, and other quality events.
• Oversee CAPA programs and effectiveness verification.
• Lead change control and continuous-improvement initiatives; ensure training before implementation.
• Lead internal audits and support government audits; maintain audit documentation and CAPA records.
• Oversee supplier qualification and approved supplier programs.
• Serve as senior quality partner to Operations, Compliance, Client Success, Engineering, IT, and leadership.
• Translate requirements into operating procedures and quality controls.
• Communicate performance, audits, risks, and CAPA progress to leadership and stakeholders.
• Support significant quality incidents and site reviews.
• Ensure adherence to policies, cGMP regulations, and safety standards.
• Support broader initiatives via leadership tasks as assigned.

Skills

Quality leadership

QMS design & implementation

Regulatory compliance

Audits & inspections

CAPA management

Change control

Root cause analysis

Executive communication

Vendor qualification

Stakeholder management

Education

Bachelor's degree or equivalent in relevant field

Job description

cGMP Consulting is seeking a senior quality leader to build and scale a comprehensive Quality Management System (QMS) across government warehouse, distribution, and regulated logistics operations. This role emphasizes autonomy, site leadership, and strategic quality program development in a fast-paced GMP setting.

The ideal candidate will lead multi-site quality programs, drive investigations and CAPA, and present quality risks to executives, auditors, and government stakeholders.