Senior Director Quality Assurance

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 Director, Quality Assurance

What you will do

Let’s do this. Let’s change the world! By taking on this leadership role, you will have the opportunity to augment the future and contribution of Quality Operations at Amgen Rhode Island (ARI) through the advancement of Amgen’s pipeline and diversified portfolio from our state-of-the-art Drug Substance manufacturing site located in West Greenwich. In this vital role, you will be responsible for actively driving operational workstreams. You will provide Quality leadership and guidance to site partners as we continue to grow and deliver our mission of "Every patient, Every Time." Your responsibilities also extend to the integration of technology in our daily activities to ensure effective and efficient tech transfer, as well as maintaining compliant ongoing operations.

As the Senior Director Quality Assurance providing oversight to two (2) manufacturing facilities, you will contribute to the development of the site Quality strategy and build and lead a team of approximately 50 associates accountable for all aspects of quality oversight of GMP manufacturing processes. This role will ensure product quality standards are met in compliance with Amgen and regulatory requirements.

Responsibilities:

• Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities (14 products) with accelerated run rate and expansion projects to support volume driven growth and innovative pipeline.

• Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition.

• Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications.

• Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards.

• Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.

• Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy.

• Develop strategies in support of regulatory inspections and site audits.

• Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties.

• Develop area budget, manage expenditure and identify productivity improvement opportunities.

• Represent ARI Quality in cross-function and cross-site forums.

• Provide Quality input to support project or operational design decisions.

• Alert management of significant quality, compliance, supply, and safety risks.

• Communicate across all levels of the organization. Facilitate development of solutions to critical business issues.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a Leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience OR

• Master’s degree and 8 years of Quality/Manufacturing/Engineering experience OR

• Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering 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:

• Bachelor’s Degree in a Life Science field

• 15 + years’ pharmaceutical industry experience

• Previous experience in Quality oversight of Biologics drug substance operations

• Strong knowledge of cGMPs and experience interacting with Regulators

• Able to drive process improvement within area of responsibility

• Able to successfully manage workload to timelines

• Leadership and 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 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.

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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.

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.