Sr. Manager Quality Assurance

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

What you will do

Lets do this! Lets change the world!

Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to FP Core Technologies 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. Works with External Supply Quality and/or other quality counterparts to ensure there is a robust plan in place when receiving methods from a CMO or supplier.

• Disposition of reports associated with FP platforms and method stewardship and ensure robust FP method stewardship program (GMP methods and verification methods used to support filings).

• Disposition of reports associated with FP modeling and material characterization to support FP development and commercial operations. Identifies compliance risks and provides mitigation strategies to support PAI and inspection success.

• Work with EH&S to gather information about ergonomics and user safety as it pertains to method development

• Work with EH&S regarding regulations pertaining to REACH and ROHS during material characterization

• Maintains strong relationship with other Quality functions to ensure feedback loops on existing methods

• Provides quality oversight of the development, maintenance, transfer and validation of physical methods including sample selection

• Provides quality advice to maintain and improve container, device, and packaging/shipping platforms

• Provides quality advice to regulatory on submission strategies associated with platforms, physical methods, and modeling

• Provides oversight of FPT deliverables associated with established FP platforms, physical methods, FP modeling, and material sciences

• Provide quality expertise and technical knowledge to Final Product Key External Initiative (KEI)

• Co-develop training materials for method transfers and stability method transfers with FPT Core Technologies

• Co-develop training materials for stability method transfers with FPT Core Technologies

• Ensures activities are in line with budget and support evidence-based resource needs

• Management, development, and selection of highly qualified staff

• Provides Quality oversight to final product core technologies activities and deliverables (A)

• Quality approval of protocols and technical reports for method development (D)

• Provides advice to inform Quality Plan (A)

• Provides advice and expertise to inform development of technical training materials for method transfer (A)

• Informs EH&S on topics relevant to inform safety, ergonomics, and/or regulations pertaining to REACH, WEEE, and ROHS (A)

• Oversight of protocols and requirements to outsource testing to labs (A)

• Approved method development, validation, and transfer reports

• Robust FP change controls, CAPAs, and NCs

• Successful FP method stewardship deliverables

• Method training materials

• Reports to Director, Final Product Technologies Quality

• Key advisor to Core Technologies Lead in Final Product Technology

• Key advisor to Innovation and Development Leads in FTPQ

• Key advisor to site quality organizations

• Key advisor to Product Quality Leaders (PQLs)

• Consult 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

• May manage a small team of staff

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

• Doctorate degree and 2 years of quality experience OR

• Masters degree and 6 years of quality experience OR

• Bachelors degree and 8 years of quality experience OR

• Associates degree and 10 years of quality experience OR

• High school diploma / GED and 12 years of quality experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• 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 FP development

• Ability to work effectively in global cross-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 cross-functional relationships

• Excellent verbal and written communication

• Ability to effectively negotiate and Influence at all levels of the organization

• Ability to drive continuous improvements

• 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelors Degree in a Science Field

• Experience in developing physical methods for combination products

• Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP

• Leadership skills and the ability to oversee multiple projects simultaneously

• 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 211

• Working knowledge of calibration standard ISO 17025

• Ability to discern user requirements for input to method development

• Able to successfully manage workload to timelines

• Ability to negotiate a position after taking feedback from multiple sources

• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Experience driving decision making by using DAI principles

• Understanding of industry requirements/expectations of a QMS

• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

• Ability to travel +/- 20% of time to domestic and international Amgen sites

• Experience with Quality Processes and systems such as Trackwise

• Experience with quality oversight of device components

• History of presenting during inspections and audits

• Able to facilitate and influence senior stakeholders and partners

• Able to successfully prioritize workload and meet timelines

• Ability to negotiate a strategic position after taking 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

• 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 FP development

• Ability to work effectively in global cross-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 cross-functional relationships

• Excellent verbal and written communication

• Ability to effectively negotiate and Influence at all levels of the organization

• Ability to drive continuous improvements

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com