Quality Assurance Senior Manager

Career Category

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.

Quality Assurance Senior Manager

What you will do

Let’s do this. Let’s change the world. Job Description

This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality.

Key Responsibilities include:

• Ensure appropriate quality oversight of suppliers in line with global regulations, define quality requirements for suppliers and monitor performance

• Quality liaison between Amgen and the supplier

• Negotiator and owner of quality agreements

• Prepare external site for inspections including development of inspection playbooks.

• Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required

• Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas

• Review/Approve supplier investigations, events and change notifications

• Quality approver of deviations, change controls, CAPA, CAPA EVs

• Identify and mitigate risk at the supplier and/or raise to management

• Perform Person in Plant activities, as deemed appropriate

• Drive audit commitments to completion

• Lead supplier audit preparation and identify areas of focus

• Continuously assess supplier status through periodic monitoring reporting

• Partner with Operations site lead on issues, improvements, site performance and overall relationship management

• Understand and implement GMP requirements internally and externally

• Up to 20% domestic and international travel required

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of Quality experience OR

• Master’s degree and 4 years of Quality experience OR

• Bachelor’s degree and 6 years of Quality Manage experience OR

• Associate’s degree and 10 years of Quality experience OR

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

Preferred Qualifications:

• 10+ years biotech or pharmaceutical industry experience

• 5+ years of experience overseeing quality of suppliers

• Experience with leading audits

• Technical knowledge related to primary components

• Experience with Quality Processes and systems such as Trackwise

• Experience with quality oversight of primary components

• History of presenting during inspections and audits

• Able to facilitate and influence senior team members and partners

• Able to successfully prioritize workload and meet timelines

• Ability to negotiate a strategic position after receiving feedback from multiple sources

• Strong project management, problem-solving, and analytical skills

• Demonstrated ability to lead cross-functional teams, consistently deliver timely, and high-quality results

• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Experience with relationship management with external parties