Quality Assurance Senior Manager

Role Summary

Quality Assurance Senior Manager

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‚Äôs 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

Qualifications

• Basic Qualifications:
  • Doctorate degree 2 years of Quality experience OR
  • Master‚Äôs degree and 6 years of Quality experience OR
  • Bachelor‚Äôs degree and 8 years of Quality experience OR
  • Associate‚Äôs 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

Preferred Qualifications

• 7-10 years‚Äô 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

Additional Requirements

• Travel both domestically and internationally about 15%