Senior Director, Product Quality

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 awardwinning 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.

Senior Director Product Quality

What you will do

Lets do this. Lets change the world. In this vital role as the leader in Product Quality you will provide strategic and technical leadership to ensure the highest standards of product quality across multiple latephase clinical and commercial programs.

This role demands a deep understanding of Amgens commercialization processes cGMP and international regulatory expectations as well as the ability to respond to emerging scientific and technical trends that impact the organization.

The successful candidate will advise and mentor team members lead crossfunctional initiatives and represent Product Quality in crossfunctional teams to drive continuous improvement and maintain compliance.

• Advise on CMC strategies and quality risk management for commercialization including strategies for in process controls specifications stability and comparability
• Provide regulatory strategic and technical advice to crossfunctional teams supporting commercialization and lifecycle management of Amgen products with scope to include all modalities from pivotal development through commercial
• Collaborate with crossfunctional leaders in Quality Regulatory Affairs Process Development Manufacturing and Supply Chain to resolve issues and advance business imperatives
• Provide functional and crossfunctional review of regulatory CMC submission content
• Serve as a mandatory attendee for PQrelated boards and committees like the Product Quality Review Board
• Engage internally and externally with Amgen colleagues industry peers health authorities and other external stakeholders to understand emerging regulatory trends influence policies and inform strategies to advance Amgen CMC imperatives
• Represent Product Quality at Operations Governance meetings
• Lead projects and crossfunctional initiatives seeking transformation or continuous improvement in business processes or quality processes
• Engage with and influence Executive Management mentor and advise staff
• Serve as decision maker advisor and stakeholder using the DAI model
• Proficiency in knowledge of cGMP and international regulatory expectations
• Understanding and responding to the impact of emerging scientific/technical trends and their implications for Amgen
• Actively mentoring new and existing team members to develop core Product Quality skills and leadership skills

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 5 years of CMC Regulatory Quality Operations Scientific or Manufacturing experience

Or

• Masters degree and 9years of CMC Regulatory Quality Operations Scientific or Manufacturing experience

Or

• Bachelors degree and11 years of CMC Regulatory Quality Operations Scientific or Manufacturing experience

AND

• In addition to meeting at least one of the above requirements you must have at least 5 years experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Advanced degree in chemistry biochemistry biology or a related biotechnology sciences field
• Expertise in the areas of protein and small molecule analysis and industry regulations
• Prior experience with a health regulatory authority conducting or overseeing CMC reviews for pharmaceutical products including experience influencing or implementing agency policies relevant to CMC reviews
• Ten or more years of pharmaceutical experience with increasing responsibility in a quality analytical development process development pharmaceutics regulatory or manufacturing environment experience
• Eight or more years working in a regulated environment (direct GMP)
• Five or more years managing staff with increasing responsibilities and larger groups
• Three or more years of experience with authoring or review of regulatory filing or similar regulatory documentation.
• Three or years of experience supporting nonconformance investigations authoring reviewing and defending critical product impacting nonconformances
• Previous experience engaging with regulatory bodies and external organizations
• Knowledge of protein and small molecule quality compliance and regulatory requirements
• Knowledge of analytical techniques used for protein molecule product quality control
• Understanding of drug substance and drug product development and manufacturing
• Strong leadership and management skills
• General knowledge of cGMP and filing regulations practices and trends pertaining to the manufacture and testing of pharmaceuticals
• Previous experience working on a crossfunctional team in a matrix environment

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 wellbeing. 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff 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 ageidentifying 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.

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.

Salary Range