Quality Assurance Manager

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.

Quality Assurance Manager

What you will do

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

Amgen is searching for a Quality Manager site lead who will be responsible for Quality and Compliance oversight of contract manufacturing/testing sites. This Quality Manager will have significant responsibility working with supplier quality and manufacturing. The Quality Manager will also provide support to Quality Senior Manager site leads.

The Quality Manager will report into External Supply Quality's North American regional team. This role can be filled in multiple locations in the United States.

Key responsibilities for this role include:

• Be an integral quality partner of Amgen’s cross-functional external supply team that includes: business operations, analytical sciences, process development, and supply chain.

• Perform general oversight and periodic evaluations of Quality performance for contract manufacturing/testing sites

• Negotiate Quality Agreements (QAGR) and ensure adherence to QAGR terms.

• Review and approve master batch records, deviations, change controls, CAPAs, CAPA-EV’s, and Product Complaints

• Provide data for Annual Product Review (APR)

• Support audits/inspections (e.g. prepare topics to be presented during inspections). Support management of audit/inspection commitments to completion

• Ensure inspection readiness (e.g. prepare playbooks, participate in mock inspections)

• Identify and mitigate risks at supplier site and raise to management as appropriate

• Perform tactical batch disposition activities in support of lot release

• Role may require occasional travel

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 OR

• Master’s degree and 2 years of quality or manufacturing experience OR

• Bachelor’s degree and 4 years of quality or manufacturing experience OR

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

• High school diploma / GED and 10 years of quality or manufacturing experience

Preferred Qualifications:

• Bachelor’s of Science degree

• 8+ years biotech or pharmaceutical industry experience

• Significant Quality and/or Manufacturing experience at small and/or large molecule DS, DP or FDP manufacturing facilities. Experience with synthetics/small molecules a plus.

• Ability to facilitate and influence senior partners and balance workload and timelines

• Ability to negotiate a strategic position after taking feedback from multiple sources

• Strong project management (PM), problem-solving, and analytical skills and familiarity with PM tools

• Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)

• Shown ability to lead cross-functional teams, consistently deliver timely and quality results

• A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issue to resolution

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Skilled in using risk based decision-making approaches

• Experience with the regulatory activities and “variation management”

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 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 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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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