Senior Specialist, Quality Assurance

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Specialist Quality Assurance

What you will do

Lets do this. Lets change the this vital role you will serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Supplier Quality Management (SQM) activities with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. You will drive quality excellence across Amgens global external network and play a central role in ensuring successful regulatory outcomes.

Key responsibilities include:

• Own and lead the SQM/GSQ inspection readiness processes ensuring best-in-class inspection execution and outcomes across global and virtual sites.

• Provide strategic and tactical leadership for inspection and audit preparation inspection and audit room execution (front room/ back room) fielding questions managing change and guiding teams through inspection and audit activities.

• Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites partnering closely with established site leads and subject matter experts.

• Collaborate broadly across GSQ SQM Global Process Owners (GPO) Amgen site networks and Affiliates to ensure strong audit/inspection preparedness and alignment to regulatory expectations and industry trends.

• Maintain and continuously improve inspection readiness processes including strategy sessions pressure tests and readiness tools; represent GSQ in audits inspections and global networks.

• Lead or support responses and improvement actions resulting from Regulatory Agency inspections Business Partner audits and Amgen Global Quality Compliance internal audits.

• Drive proactive identification communication and resolution of site and cross-functional compliance risks across the global network.

• Act as SME for QMS A&I processes supporting major initiatives such as DQMS Phase 2 implementation testing training and post-implementation support for >300 staff.

• Contribute to or lead project teams supporting business objectives including quality systems continuous improvement and digital QMS transformation. (e.g. DQMS for A&I in 2026).

Skills Youll Use Every Day:

• Risk-based decision making

• Cross-functional collaboration & leadership

• Technical writing

• Problem solving

• Continuous improvement

• Project / Program management

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The quality professional we seek is an engaged collaborative and proactive leader with the following qualifications.

Basic Qualifications:

• Doctorate degree & 2 years of Quality Compliance experience OR

• Masters degree & 4 years of Quality Compliance experience OR

• Bachelors degree & 6 years of Quality Compliance experience OR

• Associates degree & 10years of Quality Compliance experience OR

• High school diploma / GED & 12 years of Quality Compliance experience

Preferred Qualifications:

• Bachelors degree in Life Sciences or Engineering

• Experience leading or participating in key roles for Regulatory/Health Authority inspections including preparation execution and response phases

• Experience auditing and defending processes/procedures during inspections

• 7 years of related pharmaceutical industry experience (manufacturing process development QA) with increasing responsibility

• Experience in quality systems compliance data analysis project management and supplier/CMO management

• Strong understanding of EU and US cGMP exposure to GDPs and knowledge of supplier/partner quality challenges

• Demonstrated ability to work autonomously communicate effectively present data clearly and navigate ambiguity with structured problem-solving

• Experience leading cross-functional teams and driving continuous improvement initiatives

• Ability to maintain strong remote working relationships across global teams

• Ability to travel regionally and internationally as needed

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 well 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.

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.

Salary Range