Quality Assurance Senior Manager, Plant QA

Role Summary

Quality Assurance Senior Manager, Plant QA – Manufacturing Focused. Lead the Drug Substance Plant QA (PQA) team and serve as the Quality Leader for GMP Operations within the Drug Substance Commercial Manufacturing facility. Build a high-performing team, establish efficient Plant Quality processes, and ensure products are produced to quality standards and in alignment with regulatory filings. Report to the Director of Quality Assurance for Drug Substance and foster a culture of safety and quality across the organization.

Responsibilities

• Staff Management - Leads a culture of safety and quality. Maintains the physical and psychological safety of self and others. Prioritizes professional development and drives continuous improvement mindset of direct reports. Performs staff recruitment and selection, training, oversight, development and performance evaluations according to Amgen’s talent management program. Assures compliance with cGMP training requirements for staff.
• Quality Oversight - Ensures the Quality Management System processes are implemented and maintained in accordance with established procedures. Collaborate with the manufacturing team to ensure product is produced according to quality standards and in alignment with the regulatory filing. Provides direction and decision making for Quality system records and reports such as batch records, investigations, CAPAs, Change Control. Reviews and approves records and reports. May serve as record or report owner. Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Drug Substance is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks. Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Quality Leadership - Collaborates cross functionally and across the Amgen Enterprise / Network to ensure the Quality Management System processes are implemented, maintained, performed, and continuously improved in accordance with established procedures and applicable regulations. Lead and/or participate in audit and inspection activities to ensure compliance with commitments made to Regulatory Authorities and cGMPs. May provide leadership and perform additional duties within other areas of the Quality Management System, including but not limited to: Management Review, Change Review Board, Risk Management. Alerts senior management of significant quality, compliance, supply and safety risks.
• Continuous Improvement - Serves as a team member with cross-functional colleagues on improvement initiatives, regulatory inspection readiness activities, and internal audits. Collaborates with cross functional staff and colleagues to achieve the objectives of the company in a safe and compliant manner. Engage in Amgen's Operational Excellence program to develop stronger capabilities in continuous improvement.

Qualifications

• Required: High school diploma / GED and 12 years of Quality or Operations experience OR
• Required: Associates degree and 10 years of Quality or Operations experience OR
• Required: Bachelor's degree and 8 years of Quality or Operations experience OR
• Required: Master's degree and 6 years of Quality or Operations experience OR
• Required: Doctorate degree and 2 years of Quality or Operations experience
• AND - In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
• Preferred: Educational background in Life Science or Engineering.
• Preferred: Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
• Preferred: Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Product Disposition
• Preferred: Strong experience working in a GMP environment.
• Preferred: Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
• Preferred: Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
• Preferred: Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Preferred: Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
• Preferred: Demonstrated leadership in multiple functional areas.
• Preferred: Able to drive process improvement within area of responsibility.
• Preferred: Familiarity with basic project management tools and lean
• Preferred: Strong organizational skills, including ability to follow assignments through to completion.
• Preferred: Excellent written and verbal communication skills.

Skills

• Leadership and staff development
• Cross-functional collaboration and stakeholder management
• Quality Management Systems (cGMP), regulatory readiness, and documentation control
• Audit and inspection readiness
• Problem solving and root cause analysis
• Project management and continuous improvement
• Strong communication and relationship-building

Education

• High school diploma / GED and 12 years of Quality or Operations experience
• Associates degree and 10 years of Quality or Operations experience
• Bachelor’s degree and 8 years of Quality or Operations experience
• Master’s degree and 6 years of Quality or Operations experience
• Doctorate degree and 2 years of Quality or Operations experience