QA Manager, Deviations

QA Manager Deviations

Role Overview

The QA Manager (Deviations) is a key leadership role responsible for overseeing critical quality systems and providing quality guidance across manufacturing support functions. Leading a team of Quality professionals, this position ensures compliance with GMP requirements, regulatory expectations, and internal standards while driving quality performance, inspection readiness, operational excellence, and patient safety. Through effective cross-functional partnership, the role fosters a culture of quality, accountability, compliance, and continuous improvement across the site.

Key Responsibilities:

• Lead and develop a high-performing team of Quality professionals through recruitment, selection, training and development to foster a culture of safety, quality, accountability, inclusion, and continuous improvement.
• Provide strategic and operational leadership for manufacturing deviations, ensuring compliance with cGMP, GDP, Amgen standards, and global regulatory requirements.
• Oversee the effective execution of Quality Management System processes, including deviations, investigations, CAPAs, change controls, and associated quality assessments.
• Provide quality leadership and risk-based decision-making for complex quality, compliance and operational issues, escalating significant risks as appropriate.
• Partner cross-functionally with Manufacturing, Engineering, Validation, Quality Control, Supply Chain, and other stakeholders to support compliant and reliable operations.
• Lead inspection readiness activities and represent Quality Assurance during audits, inspections, and governance forums, ensuring effective management of observations, commitments, and remediation activities.
• Monitor quality system performance and trends to identify risks, drive continuous improvement, and enhance operational effectiveness.
• Support implementation of site and global quality strategies, driving simplification, standardization, and optimization of quality processes and systems.
• Promote compliance with environmental, health, safety, and sustainability requirements while fostering a safe and compliant workplace.

Preferred Qualifications

• Degree in Science, Engineering, Pharmacy, or related discipline.
• Demonstrated leadership experience managing teams, developing talent and improving performance.
• 7+ years of experience in the pharmaceutical or biotechnology industry, with progressively increasing responsibility.
• Strong expertise in GMP quality systems, including deviations, investigations, CAPA management, change controls and risk management.
• Experience supporting regulatory inspections and leading audit readiness activities.
• Proven ability to influence and collaborate effectively across functions and organizational levels in a matrix environment.
• Excellent communication, stakeholder management, facilitation, and decision-making skills.
• Strong analytical, problem-solving, and critical-thinking skills, with a focus on continuous improvement and operational excellence.