Senior Director Quality Assurance

Career Category Quality Job Description

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.

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 work streams.

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.

• 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.

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