Quality Assurance Senior Manager, Plant QA

Amgen•Holly Springs, NC

16d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Quality Assurance Senior Manager, Plant QA - Manufacturing Focused What you will do Let’s do this. Let’s change the world. As a Quality Assurance Senior Manager, you will lead our Drug Substance Plant QA (PQA) team and will serve as the Quality Leader for Good Manufacturing Practices (GMP) Operations within the Drug Substance Commercial Manufacturing facility. The QA Senior Manager PQA will play a key role in the Quality Assurance team, focused on building a strong team and establishing efficient Plant Quality processes. The QA Senior Manager will lead a team of QA staff, collaborate with cross-functional partners, and provide QA leadership and oversight in support of the operational team’s key responsibilities. Your team will work closely with the manufacturing team to assure product is produced according to quality standards and in alignment with the regulatory filing. The QA Senior Manager will report to the Director of Quality Assurance for Drug Substance (DS) and be a member of the DS QA team that coordinates and contributes to serving Amgen patients via DS supply across all the Amgen commercial facilities. As a member of this leadership team and as a member of the cross functional leadership teams serving Drug Substance supply, the QA Senior Manager will contribute to fostering and further developing the culture of Safety and Quality at ANC. The job responsibilities will include but not be limited to: 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. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Requirements

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

Nice To Haves

Educational background in Life Science or Engineering.
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.
Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Product Disposition
Strong experience working in a GMP environment.
Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
Demonstrated leadership in multiple functional areas.
Able to drive process improvement within area of responsibility.
Familiarity with basic project management tools and lean
Strong organizational skills, including ability to follow assignments through to completion.
Excellent written and verbal communication skills.

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.