Senior Principal Global Quality Systems Lead

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

• Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for interpretation, implementation, review, and approval of global quality system processes and documents
• Lead and continuously improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar
• Assess, develop, and implement global quality system improvements, including standards, practices, training, implementation tools, effectiveness measures, and performance insights
• Partner across manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, Clinical Supply, and other enterprise functions to manage process risks and enable standardized global business processes
• Monitor regulatory and industry developments, support inspection readiness, and engage with external organizations to maintain compliance and influence quality-related policies and requirements
• Support QMS Pillar leads for the health, management, and reporting across the Operational Controls pillar
• Align processes with business priorities, ensure compliance, and drive quality improvements

Requirements

• Bachelor's degree or equivalent in a scientific field, engineering, or a related discipline
• Minimum of 7 years of direct cGMP experience
• Strong knowledge of cGMP requirements and quality systems
• Demonstrated experience in at least one relevant area or modality, such as Quality Control laboratories, cell and gene therapy, or parenteral manufacturing
• Fluent in English
• Previous experience with Quality Risk Management and global quality system governance
• Previous experience with process and equipment validation, cleaning and sterilization, GMP utilities, sterility assurance, or bioburden controls
• Detailed knowledge of U.S. and European GMPs, ICH, PIC/S, and WHO expectations
• Requires visits to manufacturing sites and ability to attend external training courses, conferences, or association meetings
• Ability to travel approximately 10%
• Additional languages are preferred
• Formal training in Lean, continuous improvement methodologies, or Quality Risk Management is preferred
• Continuing education, a master's degree or higher in a science-related field, or previous facility or area start-up experience is preferred

Demonstrates extensive expertise in cGMP compliance, quality system governance, and process improvement within the pharmaceutical or biotechnology sectors. Proficient in Quality Risk Management and regulatory standards, with a strong focus on aligning quality processes with business objectives.

Highest-signal resume keywords

• CGMP Experience
• Quality Risk Management
• Process Validation
• Lean Methodologies
• Regulatory Compliance

Hard Skills

• Quality System Improvement
• Process Monitoring
• Training Development
• Performance Insights
• Cleaning and Sterilization
• Bioburden Controls
• Sterility Assurance
• Quality Control
• Manufacturing Oversight
• Regulatory Standards Knowledge

Soft Skills

• Consulting Support
• Collaboration
• Communication
• Leadership
• Problem Solving

Industry Keywords

• U.S. GMP
• European GMP
• ICH
• PIC/S
• WHO
• Clinical Supply
• Manufacturing Sites
• External Training
• Quality Operations
• Process Risks