Career CategoryQuality
Job DescriptionGCP Auditor - Global R&D AuditWhat you will doLet's do this. Let's change the world. You would be joining Amgen's R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen's portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen's R&D Quality Group.
In this vital role within R&D Quality you will be planning and participating in global audits of Amgen's clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:
- Plan, conduct and report routine and direct GCP compliance audits internationally.
- Serve as a lead auditor for complex GCP audits
- Identify and communicate compliance risks to R&D Quality management
- Host and/or play a role in regulatory authority inspections
- Contribute to or lead R&D Quality process improvement initiatives
- Author and contribute to the development of R&D Quality cross functional controlled documents
The role can entail up to 40% travel to international destinations
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
Basic Qualifications:- Doctorate degree OR
- Master's degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR
- Bachelor's degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR
- Associate's degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR
- High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience
Preferred Qualifications:- Postgraduate qualification
- Participation in process improvement initiatives.
- Extensive experience conducting international auditing in GCP or as a regulatory authority inspector
- Experience of data mining, manipulation and data analytics would be advantageous
- Excellent written and verbal communication skills
What you can expect from usAs 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.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.comIn 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.
Salary Range104,725.10USD -141,686.90 USD
