Quality Assurance Senior Manager Job Thousand Oaks area,California USA,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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.

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. 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

Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement.
Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations.
Negotiator and owner of quality agreements
Prepare external sites 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 inspections 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 elevate 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

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 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 and Veeva
Experience with quality oversight of primary components
History of presenting during inspections and audits
Able to facilitate and influence senior…