Quality Assurance Senior Manager

Amgen Inc.•Thousand Oaks, CA

63d•Remote

About The Position

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 our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world. The position serves as the Quality Alliance Lead and the primary Amgen Quality point of contact for coordination interactions with Amgen business partners. This position will also support Portfolio Strategy Quality responsibilities.

Requirements

Doctorate degree 2 years of Quality experience OR
Master's degree and 6 years of Quality experience OR
Bachelor's degree and 8 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
In addition to meeting at least one of the above requirements, you must have a minimum of 2 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

Nice To Haves

7-10 years' experience (Manufacturing, Process Development, or Quality Assurance) in the pharmaceutical/biotech industry
Experience involving the development of Quality Agreements and relationships with globally diverse partners
Work in a team matrix environment and independently interact with various levels of management
Direct experience with bulk manufacturing of biopharmaceuticals
Demonstrated proficiency leading negotiations
Excellent communication skills, both written and oral,
Knowledge of Quality Assurance functions and practices
Ability to evaluate and lead negotiations around Quality Agreements
Experience in project management (managing projects, defining scope, tracking achievements)
Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes
Appropriate cultural awareness and ability to work effectively with those from other cultures/countries

Responsibilities

Responsible for leadership and coordination of Quality as needed across Amgen, for interactions with business partners, Amgen sites, and corporate business units.
Lead strategic negotiation, development and ongoing oversight of high-impact partnerships and alliances from a Quality perspective.
Negotiate Quality Agreements and participate in the negotiation of relevant Supply agreements to ensure appropriate Quality requirements are defined.
Participate in regulatory inspections as necessary relating to partnerships/alliances to ensure successful business outcomes.
Coordinate and facilitate partner visits by business partner Quality representatives.
Coordinate specific activities relating to audits of Amgen by business partners.
Lead and manage partner Quality forums and Partner Annual Reviews.
Collaborate with Business Development partners to ensure business priorities are successfully completed.
Participate in the development of new partner strategic plans and participating in the execution of application tasks to successfully accomplish project goals.
Develop strong partnership with internal manufacturing network and relevant contract manufacturing sites to ensure alignment.
Quality representative in External Supply Site Selection processes, including, performing Due Diligence visits, participating and delivering Site Selections as Quality representative, qualifying suppliers by performing Quality audit, authoring and negotiating Quality Agreements, and authoring Periodic Monitoring Reports; works in collaboration with External Supply Quality function that oversees CMO/CTL.
Liaise with peers within the Quality organization to ensure continued evolution of Amgen's Quality system are aligned with developing partnership and alliance needs.
Responsible for the execution of projects necessary to achieve corporate and departmental goals.
Ability to conduct and act upon thoughtful risk analysis. Knowledge of continuous improvement principles and experience in implementing continuous improvement efforts across a global team.
Establish standard processes for completion of key tasks and drive continuous improvement activities.

Benefits

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

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