Quality Compliance, Director

Amgen SA; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Bonus program

Stock-based incentives

Time-off plans

Flexible work model

Job summary

Amgen seeks a Director of Quality Compliance to lead GMP compliance initiatives and regulatory readiness across new sites and expansions of manufacturing facilities. You will partner with QA and cross-functional teams to ensure sustained quality systems and regulatory alignment.

Ideal candidates bring extensive GMP experience, a strong track record in regulatory submissions, and the ability to guide complex investigations and accuse continuous improvement while supporting digital strategies.

Qualifications

• Bachelor’s degree required with 9 years of Quality Compliance experience, or Master’s with 7 years, or Doctorate with 4 years.
• Strong GMP compliance, inspection readiness, and regulatory knowledge required.
• Experience supporting drug substance/bulk manufacturing operations preferred.

Responsibilities

• Provide compliance support for deviations investigations and inspection topics.
• Lead/regulatory communications and responses to regulatory filings and inquiries.
• Support readiness for regulatory inspections and provide cross-functional guidance.
• Draft/review regulatory communications and inspection responses.
• Lead strategy during regulatory inspections and coordinate cross-functional teams.
• Develop inspection playbooks and ensure staff readiness.
• Advise on new technologies and changes to quality processes.

Skills

Quality Compliance

Regulatory readiness

GMP knowledge

Audit leadership

Education

Bachelor's degree

Master's degree

Doctorate degree

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.

QUALITY COMPLIANCE, DIRECTOR

What you will do

Let’s do this. Let’s change the world. In this vital role you will reporttotheExecutive Director of RegulatoryCompliance andprimarily provide direct support forcompliancerelated deliverables associated to new sites or expansion of existing manufacturing sites.

• Serve as a strategic partner supporting theQuality Improvement Plans(QIP) and Operational Readiness program by providing independent complianceexpertise, and objective guidance to support sustained GMP readiness and operational excellence.
• Partner closely with QA Operational Readiness Team and cross-functional leadership to evaluate remediation strategies, operational readiness initiatives, and quality system enhancements, ensuring alignment with global quality standards, regulatory expectations, and enterprise best practices.
• Participate in operational readiness reviews, andGo/No-Godecision-making processes to support objective, evidence-based assessments while promoting inspection readiness, effective risk management, and the long-term sustainability of the site's Quality Management System.
  
• Draft and/orreview regulatory communicationsin the form ofinspectionobservationresponses,third party audit finding responses,responses to questionsassociatedwithregulatoryfilingsand other information requests.
• Conduct inspection readiness exercises(strategy, preparation, pressure testing)in support of both scheduled and unscheduled regulatory inspections, in coordination withthesites andSiteInspectionLifecycleManagement staff.
• Assistwith generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections.
• Lead virtual or on-site strategy support during regulatory inspections. May lead cross-functional regulatory response teams.
• Provide direct compliance supportfordeviation investigationandkeyinspection topics.Ensureappropriate technicalcontent and documented rationale is available in support of investigation conclusions.Participate on Investigation Advisory Boards as Advisor, asrequired.
• Providecompliance advice onnew technologiesand proposed changes to quality processes in support of continuous improvementand the implementation of new digitalstrategies.

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 9 years of Quality Compliance experience OR
• Master’s degree and 7 years of Quality Compliance experience OR
• Doctorate degree and 4 years of Quality Compliance experience

Preferred Qualifications:

• Strong background in Quality Compliance within a GMP-regulated environment.
• Experience supporting drug substance and bulk manufacturing operations.
• Expertise in GMP compliance, inspection readiness, and regulatory requirements.
• Experience with drug product manufacturing and compliance.

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.

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.

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.