Inspection Readiness Manager

Career Category

Clinical

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.

Inspection Readiness Manager

What you will do

Lets do this. Lets change the this vital global role you will oversee the execution of high-quality GCP & IVDR Inspection Readiness & Preparation. You will own the Site Inspection Readiness & Preparation project management for all clinical trials and programs covering early late and observational programs. You will also participate in developing and implementing innovative cross-functional Inspection Readiness (IR) Inspection Preparation and Operational Quality (OQ) initiatives using curiosity tenacity and a critical thinking mind. This role offers great scope for a high level understanding the drug development process how Amgen is organized and crucial role quality has ensuring successful regulatory inspections and products reaching the market with speed and data integrity. As a growth area creativity and engagement and drive are key characteristics of this role alongside excellent communication. You will support Global Development Operations partnering closely with R&D Quality and work broadly across Global Development

Responsibilities

Own and lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools materials apps and systems. Leading teams through smooth inspection experiences and successful inspection outcomes.

Innovate continuous improvement in operational quality inspection readiness by identifying and acting on program study and site quality incidents trends and updating existing tools or creating new support materials or workstreams

Lead as appropriate and collaborate with the IR Support Team on function specific GCP & IVDR IR Study Health and Quality initiatives as indicated by operational observation poor risk mitigation quality data reports inspection observations and findings or specific country requirements e.g. China.

Advisory role to the business in achieving Inspection Readiness Inspection and a limited role in internal audits

Maintaining and managing IR SharePoint (SPO) site

Managing Regulatory Inspection Preparation folders and access

Supporting the Inspection Readiness & Operational Quality Senior Manager

Provide mentorship to student interns

What we expect of you

We 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

Masters degree and 2 years of relevant experience OR

Bachelors degree and 4 years of relevant experience OR

Associates degree and 8 years of relevant experience OR

High school diploma / GED and 10 years of relevant experience

Preferred Qualifications :

Bachelor Degree in Life Sciences or RN or equivalent

7 years work experience in life sciences or medically related field including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech pharmaceutical or CRO company

Experience of or oversight of global clinical trial conduct

Experience driving and leading process development and / or improvement

Experience as an Inspection or Risk Manager preferred

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 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 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.

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. 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.

Salary Range

Required Experience :

Manager

Key Skills

Bidding,Impromptu,Accomodation,Aircraft Operations,F&B,IT Solution Sales

Employment Type : Full-Time

Experience : years

Vacancy : 1