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. 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.

DIRECTOR, QUALITY ASSURANCE

What you will do

Let’s do this. Let’s change the world. In this vital role you will be accountable for leading the quality team supporting drug substance manufacturing execution activities within our site’s second FleX Batch manufacturing facility.

As a QA Director, you will build and lead a high-performing quality organization responsible for supporting 24/7 manufacturing operations and will contribute to the development of the site Quality strategy leading teams accountable for all aspects of quality oversight of GMP systems and operations, while fostering a culture of execution excellence, accountability, and continuous improvement.

• Provide Quality input and expertise to support project and operational design decisions.
• Lead operational readiness activities to implement quality systems, programs, business processes and procedures.  Track progress and communicate status.
• Lead and participate in Quality Risk Assessments.
• Build organization according to hiring strategy that supports project milestones. 
• Recruit, coach, develop, motivate, and retain staff. 
• Ensure ongoing organizational structure capable of adapting to evolving business needs.
• Drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.
• Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.
• Represent ANC Quality in cross-function and cross-site forums and in collaborations with Quality leaders across the Amgen network.
• Alert management of significant quality, compliance, supply, and safety risks.
• Communicate across all levels of the organization.  Facilitate development of solutions to critical business issues.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience OR
• Master’s degree and 8 years of Quality/Manufacturing/Engineering experience OR
• Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
  
  In addition to meeting at least one of the above requirements, you must have at least 4 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:

• Bachelor’s Degree in a Science field
• 15+ years of experience in Quality within the biopharmaceutical or regulated manufacturing industry
• Previous experience in Quality oversight of Biologics drug substance operations
• Strong knowledge of cGMPs and experience interacting with Regulators
• Able to drive process improvement within area of responsibility
• Able to successfully manage workload to timelines
• Proven experience supporting regulatory inspections and site audits
• Demonstrated leadership of cross-functional teams within a manufacturing site
• Experience driving operational excellence and continuous improvement initiatives
• Excellent communication, leadership, and influencing skills

Competencies:

• Strategic Thinking (Site Execution Focus)
• Regulatory & Compliance Expertise
• Operational Excellence
• Leadership & Team Development
• Change Management
• Data-Driven Decision Making

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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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Salary Range

181,620.35USD -245,721.65 USD