Global Quality Systems Leader — GMP & Compliance Strategy

Jobtailor; Indianapolis (IN); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor seeks an experiencedQuality Systems leader to oversee global processes, governance, and continuous improvement within pharmaceutical operations. You will partner with manufacturing, suppliers, R&D, and Clinical Supply to align quality programs with business goals and regulatory expectations.

The candidate should have deep cGMP knowledge, 7+ years of experience, and hands-on expertise in risk management, process validation, and regulatory compliance across US/EU contexts.

Qualifications

• Bachelor's degree or equivalent in a scientific field, engineering, or related discipline.
• Minimum of 7 years of direct cGMP experience.
• Strong knowledge of cGMP requirements and quality systems.
• Experience in at least one area such as Quality Control labs, cell and gene therapy, or parenteral manufacturing.
• Fluent in English.
• Experience with Quality Risk Management and global quality system governance.
• Experience with process and equipment validation, cleaning and sterilization, GMP utilities, sterility assurance, or bioburden controls.
• Knowledge of U.S. and European GMPs, ICH, PIC/S, and WHO expectations.
• Willingness to travel ~10%.
• Additional languages preferred; Lean/quality training or master's start-up experience preferred.

Responsibilities

• Provide oversight and consulting support to Global Process Owners and networks for global quality system processes and documents.
• Lead and improve governance, management review, and process monitoring across Operational Controls.
• Assess, develop, and implement global quality system improvements including standards, training, tools, and performance measures.
• Partner across manufacturing, suppliers, marketing affiliate quality ops, R&D, Clinical Supply, and other functions to manage process risks.
• Monitor regulatory developments, support inspection readiness, and engage with external organizations to maintain compliance.
• Support QMS Pillar leads for health, management, and reporting across Operational Controls.
• Align processes with business priorities, ensure compliance, and drive quality improvements.

Skills

CGMP Experience

Quality Risk Management

Process Validation

Lean Methodologies

Regulatory Compliance

Quality System Improvement

Process Monitoring

Training Development

Bioburden Controls

Sterility Assurance

Education

Bachelor's degree in a scientific field or engineering

Master's degree in science-related field (preferred)

Job description

Jobtailor seeks an experiencedQuality Systems leader to oversee global processes, governance, and continuous improvement within pharmaceutical operations. You will partner with manufacturing, suppliers, R&D, and Clinical Supply to align quality programs with business goals and regulatory expectations.

The candidate should have deep cGMP knowledge, 7+ years of experience, and hands-on expertise in risk management, process validation, and regulatory compliance across US/EU contexts.