Quality Assurance Senior Manager
Quality Assurance Senior Manager
United States - Remote APLICAR AHORAJoin 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
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:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.