Senior Manager, Quality Engineering & Support

Position Summary

The Senior Manager, Quality Engineering & Support is responsible for providing strategic and operational quality leadership for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems, Warehouse, and Quality Control (QC) operations.

This role ensures that all supported functions operate in compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH guidelines, Data Integrity requirements, and company quality standards. The incumbent serves as the Site Data Integrity (DI) Champion and is accountable for the quality oversight of qualification and validation activities, engineering and computerized system lifecycle management, warehouse and laboratory compliance, risk management, inspection readiness, and continuous improvement initiatives.

The Senior Manager provides independent quality decision-making, leadership of quality systems, stakeholder management, resource and budget planning, and team development while safeguarding product quality, patient safety, data integrity, and regulatory compliance.

Key Responsibilities

Quality Oversight & Compliance

. Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations.

. Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards..

. Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance.

. Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (QRAs), gap assessments, SOPs, protocols, validation documentation, and technical reports.

. Support and participate in audit and inspection readiness programs and represent Quality Operations during client audits and regulatory inspections.

. Drive a culture of quality, compliance, inspection readiness, operational excellence, and continuous improvement.

Validation, Engineering & System Quality Support

. Review and approve qualification and validation lifecycle activities, including facilities, utilities, equipment, HVAC, process gases, computerized systems, process validation, and cleaning validation.

. Review and approve validation protocols, reports, qualification documents, and associated quality records.

. Provide quality oversight for engineering changes and lifecycle management of GMP infrastructure and systems.

. Ensure facilities, utilities, and computerized systems remain in a validated and compliant state.

Warehouse & Quality Control Oversight

. Provide quality oversight for warehouse operations, including material receipt, storage, dispensing, inventory management, and distribution activities.

. Support material disposition and release decisions impacting GMP operations.

. Provide quality oversight for QC operations, including laboratory investigations, OOS/OOT events, CAPAs, and change controls.

. Ensure warehouse and laboratory operations remain inspection-ready and compliant.

Data Integrity Leadership

. Serve as the Site Data Integrity (DI) Champion.

. Lead and maintain the site's Data Integrity Governance Program.

. Promote and embed ALCOA+ principles across the organization.

. Review and approve Data Integrity Risk Assessments, gap assessments, and remediation plans.

. Drive Data Integrity training, compliance monitoring, and continuous improvement programs.

. Quality Systems & Risk Management

. Review and approve deviations, investigations, CAPAs, change controls, Quality Risk Assessments (QRA), gap assessments, SOPs, protocols, validation documents, and technical reports.

. Ensure quality risk assessments and compliance assessments are scientifically sound and aligned with ICH Q9 principles.

. Lead remediation activities and monitor effectiveness of corrective and preventive actions.

. Provide quality oversight and decision-making for quality and compliance risks.

Leadership & Stakeholder Management

. Lead, coach, develop, and retain a high-performing Quality Engineering & Support team.

. Develop department resource plans to support business growth, site expansion, project execution, and operational demands.

. Manage staffing, succession planning, talent development, and organizational capability building.

. Oversee project timelines, quality deliverables, departmental KPIs, strategic initiatives, and compliance objectives.

. Manage departmental budget planning and resource allocation to support operational and business objectives.

. Collaborate effectively with Engineering, Validation, Manufacturing, Warehouse, QC, Supply Chain, IT, Regulatory Affairs, and global stakeholders to ensure alignment on quality and compliance expectations.

. Support site expansion, technology transfer, validation programs, digitalization initiatives, and business growth activities.

. Provide leadership during quality escalations, compliance risks, and critical quality events, and support executive decision-making.

. Foster a culture of quality, data integrity, accountability, continuous improvement, and operational excellence.

Qualifications and Experience

. Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, Computer Science, Information Systems, or a related discipline.

. Advanced degree preferred.

. Minimum 10 years of experience in pharmaceutical, biotechnology, biologics, ADC, or CDMO environments.

. Minimum 5 years of leadership experience within Quality Assurance, Validation, Engineering Quality, QC Quality, or related GMP functions.

Technical Competencies

. Strong knowledge of FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Annex 11, 21 CFR Part 11, and Data Integrity requirements.

. Expertise in validation lifecycle management, Quality Risk Management, compliance gap assessments, and GMP quality systems.

. Strong understanding of engineering systems, utilities, HVAC, process gases, computerized systems, warehouse operations, and QC laboratory processes.

. Excellent quality decision-making, stakeholder management, problem-solving, and communication skills.

. Ability to balance business objectives while maintaining the highest standards of quality and regulatory compliance.