Quality Assurance Senior Manager- US Remote

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. In this vital role you will be responsible for Quality and Compliance oversight of contract manufacturing/testing sites. This Quality Sr Manager will have significant responsibility working with supplier quality and manufacturing. The Quality Sr Manager will report into External Supply Quality's North American regional team. This role can be filled in multiple locations in the United States.

Responsibilities:

• Perform general oversight and periodic evaluations of Quality performance for contract manufacturing/testing sites.
• Negotiate Quality Agreements (QAGR) and ensure adherence to QAGR terms.
• Review and approve master batch records, test methods, deviations, change controls, CAPAs, CAPAEV’s, and Product Complaints
• Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site
• Provide data for Annual Product Review (APR).
• Support audits/inspections (e.g. prepare topics to be presented during inspections). Support management of audit/inspection commitments to completion
• Represent Amgen at product-specific regulatory inspections and/or during notified body audits of the contract manufacturing site.
• Ensure inspection readiness (e.g. prepare playbooks, participate in mock inspections)
• Identify and mitigate risks at supplier site and raise to management as appropriate
• Perform tactical batch disposition activities in support of lot release
• Role may require occasional travel

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 and compliance experience

Or

Master’s degree and 4 years of quality and compliance experience

Or

Bachelor’s degree and 6 years of quality and compliance experience

Or

Associate’s degree and 10 years of quality and compliance experience

Or

High school diploma / GED and 12 years of quality and compliance experience

Preferred Qualifications:

• Bachelor’s of Science degree
• 8+ years biotech or pharmaceutical industry experience.
• Significant Quality and/or Manufacturing experience at small and/or large molecule DS, DP or FDP manufacturing facilities. Experience with synthetics/small molecules a plus.
• Ability to facilitate and influence senior partners and balance workload and timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources.
• Strong project management (PM), problem-solving, and analytical skills and familiarity with PM tools.
• Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing).
• Shown ability to lead cross-functional teams, consistently deliver timely and quality results.
• A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issue to resolution.
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
• Skilled in using risk based decision-making approaches
• Experience with the regulatory activities and “variation management”

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 su