Quality Assurance Manager

About this role

Career Category Quality Job Description 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.

QA Manager What you will do Let’s do this. Let’s change the world. In this vital role you will oversee the daily operations of the quality assurance team, ensuring that the company's products meet established quality standards. They implement and manage QA systems, coordinate audits, and lead initiatives to address and prevent quality issues. Responsibilities: • Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensuring the facility operates successfully, efficiently, compliantly, and safely.

• Provide quality oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.

• Lead the quality assurance team with a focus on strategic direction, staff development, and maintaining a high-performance culture.

• Champion quality initiatives and collaborate with cross-functional teams to drive and deliver continuous improvement projects.

• Process optimization - assess and optimize quality processes to enhance efficiency and effectiveness

• Ensure compliance with cGMP practices and regulatory requirements.

• Provide leadership and support during both internal/external audits and inspections and audits. Will directly interact with regulatory agencies during on-site inspections.

• Develop and manage training programs to ensure team competencies and understanding of cGMP requirements.

• Manage quality-related issues effectively, ensuring solutions are implemented to prevent recurrence.

• Evaluate team performance and provide coaching to support career growth and professional development.

• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.

• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.

• Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.

• Flexibility to cover different shifts as required by the 24/7 facility production schedule. This role could support a day or swing shift schedule, including partial weekend coverage as part of the standard shift structure.

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. Basic Qualifications: • Doctorate degree OR

• Master’s degree and 3 years of quality experience OR

• Bachelor’s degree and 5 years of quality experience OR

• Associate’s degree and 10 years of quality experience OR

• High school diploma / GED and 12 years of quality experience

In addition to meeting at least one of the above requirements, you must have 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 Qualifications: • Bachelor’s Degree in Science

• 5 plus years of aseptic processing experience in QA or Manufacturing

• Regulatory Knowledge : Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements.

• Leadership Skills : Strong leadership and people management skills, with the ability to mentor, develop, and motivate a team.

• Analytical Thinking : Excellent analytical and problem-solving skills, with the ability to make sound decisions based on data.

• Communication Skills : Exceptional communication and interpersonal skills, with the proficiency to interact effectively with all levels of the organization and external partners.

• Attention to Detail : High attention to detail and the ability to manage multiple priorities in a fast-paced environment.

• Continuous Improvement : A commitment to continuous improvement and staying current with the latest industry trends and best practices.

• Aseptic Knowledge : Expertise in aseptic processing and cleanroom operations, with a focus on maintaining sterility and preventing contamination.

• Risk Management : Ability to identify, assess, and mitigate risks to product quality and patient safety.

• Operational Excellence : Experience in supporting manufacturing operations, with a focus on efficiency, compliance, and safety.

• Collaboration : Proven ability to develop strong partnerships and work collaboratively with cross-functional teams, including manufacturing and Facilities & Engineering (F&E) colleagues.

• Audit and Inspection Readiness : Experience in preparing for and leading audits and inspections by regulatory authorities.

What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative c

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