Career Category

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.

Senior Manager Quality Assurance - Drug Product Manufacturing

What you will do

Let’s do this! Let’s change the world!

The senior manager of Drug Product (DP) Quality Assurance effectively manages the daily work of direct reports responsible for the quality oversight of formulation, aseptic filling, and visual inspection activities in the DP manufacturing facility at Amgen, Thousand Oaks. The QA Senior Manager will also be responsible for advancing quality systems, clinical and commercial new product introductions, reliable product disposition, investigations, and managing change within the DP facility. They oversee the implementation of QA policies and procedures, support audits/inspections, handle quality issues, and ensure compliance with industry regulations. The QA senior manager contributes to an organizational culture of safety and quality ensuring staff safety and that the company's products meet quality standards.

Key responsibilities Include:

• Partner with our colleagues in Manufacturing, Process Development, Supply Chain, Facilities and Engineering, and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.

• Collaborate with senior managers in partner organizations to support organizational goals and strategy.

• Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.

• Ensures that facilities, equipment, materials, organization, processes, procedures, and products align with cGMP practices and other applicable regulations.

• Keeps up to date with emerging trends and regulatory advances in the areas of aseptic processing and drug product inspection and ensures appropriate staff development and training in areas of responsibility.

• Champions Continuous Improvement initiatives, programs and projects.

• Ensures that changes that could potentially impact product quality are assessed according to procedures.

• Ensures that deviations from established procedures are investigated and documented.

• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Collaborates cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations.

• Takes immediate action when aware of significant quality, compliance, supply and safety risks, often requiring the coordination of activity across organizational units.

• Represents the quality unit during audits and inspections as needed.

• Supports internal/external audits and inspections as part of the audit/inspection management team as needed.

• Completes required assigned training and manages team training to permit execution of required tasks.

• Performs additional duties as specified by management.

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 individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of quality or manufacturing experience OR

• Master’s degree and 6 years of quality or manufacturing experience OR

• Bachelor’s degree and 8 years of quality or manufacturing experience OR

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

• High school diploma / GED and 12 years of quality or manufacturing 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

Preferred Qualifications:

• 5 years of Quality experience, with at least 2 years of Management within quality assurance

• Experience in aseptic processing, sterilization practices and processes.

• Experience interacting with multiple sites.

• Working/detailed knowledge of GMPs, regulations, quality requirements as related to aseptic processing in US and multiple jurisdictions.

• Proven leadership and organizational skills.

• Skilled in technical writing and critical thinking.

• Computer Skills: Microsoft Excel, Word, Power Point, Smartsheet; Adobe Acrobat; database related platforms.

• Good organizational, communication and presentation skills, effective project and time management skills, and ability to work well under pressure.

• Highly organized with excellent attention to detail.

• Motivated, self-directed, able to work autonomously but also with proven ability to work in a team environment.

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 contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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