Quality Compliance, Senior Manager

Career Category

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.

Quality Compliance Senior Manager

What you will do

Lets do this. Lets change the world. Lets do this. Lets change the this vital role you will be responsible for driving Global Quality Compliance Audits and assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:

• Coordinates leads or participates in Corporate Quality Compliance Audits of Corporate Quality Management System Amgen sites Contract facilities Affiliates and Critical Service providers to assess compliance with all applicable regulations and to identify top compliance risks.

• Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies.

• Implements risk assessments.

• Ensure completion maintenance and sustainability of the assigned training per specific roles to support the audit process (e.g. read and understand how to apply regulatory requirements including changes to regulations guidelines and standards trends and expectations as applicable).

• Has documented experience and working knowledge of Amgens competencies including but not limited to manufacturers or intermediates API/drug substance drug product combination products medical devices and laboratories.

• Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings.

• Serves as subject matter expert on global regulated requirements and inspectional commitments as applicable.

• Provides support for domestic and international Regulatory Authority Inspections when necessary.

• Provides technical support/compliance review of multi-site/global documents resolving compliance issues if/when necessary.

• Interacts with other functional leads to ensure that Amgen Standards strategies and direction are aligned with existing regulations and regulatory expectations.

• Alerts senior and/or executive management of significant quality and compliance risks.

• Provides support for audit and inspection metrics as vital.

• Supports Continual Improvement initiatives programs and projects.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The compliance professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of compliance experience OR

• Masters degree and 4 years of compliance experience OR

• Bachelors degree and 6 years of compliance experience OR

• Associates degree and 10 years of compliance experience OR

• High school diploma / GED and 12 years of compliance experience

Preferred Qualifications:

• Lead Auditor Certification

• Audit Experience in Drug Substance (DS) Drug Product (DP) Finished Drug Product (FDP) Medical Device Combination Product and/or Active Pharmaceutical Ingredients (API) and Small Molecule

• Strong communication skills both verbal and written

• Domestic and International travel up to 50%

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 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.

Salary Range