Quality assurance serp_jobs.h1.location_city

Quality Assurance Senior Manager

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 missionto serve patients living with serious illnessesdrives 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.

Responsibilities include :

• 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.
• Travel both domestically and internationally about 15%
• Remote work option may also be considered

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 :

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.

Preferred Qualifications :

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 :

Apply now and make a lasting impact with the Amgen team.