Senior Director Quality Assurance

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 missionto serve patients living with serious illnessesdrives 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.

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 :

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 :

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 :

Apply now and make a lasting impact with the Amgen team.