Senior Associate, R&D Compliance

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.

Senior Associate, R&D Compliance

What you will do

Let’s do this! Let’s change the world! In this vital role you will Strengthen and advance Amgen’s R&D QMS. Provide quality support for Amgen programs for all stages of products in clinical development.

• Supports Research and Development Quality Manager (RDQ)

• GCP Resource - Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology and lessons learned

• Participate as a member of the Clinical Study Team (CST) and attend relevant CST meetings

• Support review and provide quality input to other key study documents as needed, including, but not limited to, ICF, vendor manuals, site monitoring plan

• Provide quality oversight of key risk-based quality deliverables, including CT-RACT, Quality Oversight Plans, and other plans that involve rating of risk, monitoring risks for action, and root cause analysis to ensure that actions are commensurate with risks to patient safety, rights, welfare and trial integrity

• Support preparation, 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 collaborators

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

• Support GxP training function with R&D assessments and assignments

• Collaborate with other Amgen R&D Quality functions

Quality Assurance including Audits

• Support RDQ Managers with risk-based GCP audits (investigator site audits, directed audits, affiliate audits, service provider audits and study level audits, and institutional level audits).

• Support the development of TA-specific Quality Assurance plans and site audit selection that are risk based and efficient.

• Provide support for vendor assessments/evaluations

• Support response generation for audit findings and self reported deviations

Inspection Readiness activities, and Inspection Management

• Support Clinical Study Team on review of Inspection readiness plans

• Support inspection management lead on pre-inspection activities for programs

• Support regulatory inspections of Amgen studies at investigator sites and Amgen Facilities

• Support Pre-Inspection site visits

• Support the review responses to regulatory authority inspections reports before their submission to authorities and ensure that CAPA plans are executed as required per Amgen procedures and regulatory authority commitments

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:

• High school/GED + 4 years quality compliance work experience OR Associate’s + 2 years quality compliance work experience OR Bachelor’s + 6 months quality compliance work experience OR Master's

Preferred Qualifications:

• Minimum of 3 years in biopharmaceutical industry 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.

• Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities

• Oversight and application of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.

Knowledge

• Understanding of Clinical R&D activities and Global Regulations

• Knowledge and application of international requirements of Good Clinical Practice (GCP)(required) or Good Pharmacovigilance Practice (GPV) and/or Good Laboratory Practice (GLP)

• Knowledge of R&D processes and operations

• Knowledge of the Regulatory Submission and Inspection Management procedures.

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

Key Competencies

• Ability to work under pressure and maintain flexibility

• Attention to detail

• Knowledge of 21 CFR 11, SO, 54, 56, 58, 312, and 812 as well as ICH E6R3

• Proficient in Microsoft Office

• Professional, proactive demeanor

• Strong interpersonal skills

• Excellent written and verbal communication skills

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, including remote and hybrid work arrangements, where possible

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

careers.amgen.com

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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.

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