Senior Quality Engineer

Lets do this. Lets change the world. In this vital role you will be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.

• Co-develop training materials for stability method transfers with CPO
• Ensures activities are in line with budget and support evidence-based resource needs
• Provides quality oversight of the development, maintenance, transfer and validation of physical methods including sample selection
• Provides Quality guidance to CPO activities and results
• Quality approval of protocols and technical reports for method development
• Provides advice to inform Quality Plan
• Provides advice and expertise to inform development of technical training materials for method transfer
• Oversight of protocols and requirements to outsource testing to labs
• Review/Approve method development, validation, and transfer reports
• Robust change controls, CAPAs, and NCs
• Successful CPO method stewardship work
• Method training materials
• Reports to manager CPOQ Core in Thousand Oaks.
• Key advisor to Core Technologies Lead
• Advisor to Innovation and Development Leads
• Advisor to site quality organizations
• Advisor to Product Quality Leaders (PQLs)
• Collaborate with and/or provide advice to Regulatory to inform submissions
• Align with Attribute Sciences where similar networks or governances are established
• Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliers

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of Quality experience OR
• Bachelors degree and 6 to 8 years of Quality experience OR
• Diploma and 10 to 12 years of Quality experience

Preferred Qualifications:

• Deep and broad understanding of quality processes including change control, risk assessment and management, etc.
• Familiarity with the characterization and modeling techniques being employed in Combination product development
• Ability to work effectively in global multi-functional teams and in a highly matrixed team environment
• Strong problem solving, trouble shooting, and analytical skills
• Advanced technical writing skills
• Constructively progress to outcomes despite uncertainty or ambiguity
• Motivate change, efficiency, and strong multi-functional relationships
• Ability to drive continuous improvement
• Quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelors Degree in a Science Field
• Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP
• Familiar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025
• Ability to negotiate a position after taking feedback from multiple sources
• Experience driving decision making by using DAI principles
• Understanding of industry requirements/expectation Ability to travel +/- 20% of time to domestic and international Amgen site
• Experience with Quality Processes and systems such as Trackwise
• Experience with quality oversight of device components
• History of communicating during inspections and audits
• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution