Quality Compliance Manager

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 Compliance Manager

What you will do

Let's do this Let's change the world

We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area.

In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals).

Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials.

Responsibilities

• GCP Subject Matter Expert - Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology.

• Provide quality oversight for Amgen programs for all stages of products in clinical development

• Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights

• Support the establishment of regional expertise to ensure quality and compliance to local Regulations

• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management activities, and Serious Breaches/ Privacy Issues

• Ensure TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes

• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)

• Manage/support regulatory inspection and review responses.

• Prepare, analyze and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key partners

• Support Monthly meetings with program level CPO senior management/associate directors to review, but not limited to, the following: ongoing quality issues, quality trends, program filing timelines and potential inspections.

• Support response generation for audit findings and self reported deviations.

• Support the establishment of regional expertise to ensure quality and compliance to local regulations

• Provide Study Specific Vendor Quality Oversight

• Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study level audits)

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

• Doctorate degree OR

• Master's degree and 2 years of quality management experience OR

• Bachelor's degree and 4 years of quality management experience OR

• Associate's degree and 8 years of quality management experience OR

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

Preferred Qualifications:

• Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.

• Thorough understanding of Clinical R&D activities and Global Regulations.

• Knowledge of the Regulatory Submission and Inspection Management procedures.

• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.

• Excellent verbal and written communication skills, including strong business writing abilities and active listening.

• Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format.

• Strong analytical, critical-thinking, and decision-making abilities.

• Capability to understand and articulate technical concepts and literature in spoken and written English.

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.

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.