Manager QA - Nights

About this role

Career Category Operations 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Manager QA - Nights

What you will do Let’s do this. Let’s change the world. In this vital role you will hire, train, develop, and manage Quality Assurance professionals to successfully deliver on role to support GMP Manufacturing and to manage change in an effective, efficient and compliant manner. This individual will be responsible for overseeing our Night shift Quality Assurance teams, and the schedule will be M-F 6pm - 2:30am.

Additional Responsibilities: • Independently determine approach to managing daily operations; guided by general policies and management guidance

• Develop or contribute to the development of procedures and standards by which others will operate.

• Interpret and execute standards and procedures directly affecting work activities

• Develops and communicates goals and objectives to staff and key partners

• Monitor goal performance and coordinate action for improvement of shift and overall PQA performance by championing department OPEX efforts. Assist project teams in establishing priorities, project timelines and in securing resources.

• Actively represent Quality Assurance on incident triage teams or support efforts by providing guidance and/or technical leadership

• Partner with internal personnel at various management levels to resolve issues, establish direction, obtain resources, and drive change

• Reviewing and approving operational procedures and product manufacturing procedures, approving process validation protocols and reports for manufacturing processes, and approving environmental characterization reports and change control documents.

• Approving non-conformances, representing QA on project teams and approving change-over completion controls.

• Leading investigations, as well as leading plant and site audits.

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a team leader with these qualifications.

Basic Qualifications • High school diploma / GED and 12 years of Quality or Manufacturing experience OR

• Associate’s degree and 10 years of Quality or Manufacturing experience OR

• Bachelor’s degree or and 5 years of Quality or Manufacturing experience OR

• Master’s degree and 3 years of Quality or Manufacturing experience OR

• Doctorate degree

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 Life Sciences, Engineering or related field

• 6+ years of quality assurance or combination of quality and manufacturing experience in the biotechnology/pharmaceutical industry

• 2+ years of supervisory/management experience

• Experience in areas of manufacturing, investigations, CAPA, product release, validation and/or change control

• Experience in regulations, standards and guidelines that apply to biotech manufacturing in a multi-product environment

• Ability to develop meaningful team and staff goals, manage performance and coach and develop staff

• Ability to manage to established timelines and deliver results to meet or exceed department and company goals and objectives.

• Thorough knowledge of monoclonal antibody manufacturing or ability to apply previous biotech manufacturing knowledge to understand manufacturing deviations

• Ability to communicate clearly, facilitate discussions and present to audiences at all levels of a site organization

• Decisive and independent risk-based decision-making ability on the floor to support manufacturing needs

• Ability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant manufacturing

What you can expect of 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 culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company co

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