Sr. Quality Assurance
- Employer
- Amgen
- Location
- Cambridge, MA
- Start date
- Nov 29, 2021
View more
- Discipline
- Engineering, Quality, Quality Control
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Live
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.
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 internal 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
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)
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
Advisor to Innovation and Development Leads in FTPQ
Advisor to site quality organizations
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
Win
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.
Basic 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 management of projects, programs or directing the allocation of resources
Requirements:
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
l 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
Preferred Requirements:
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 211Working 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/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 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
Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
Deep and broad understanding of quality processes including change control, risk assessment and management,
Strong problem solving, trouble shooting, and analytical skills
Advanced technical writing skills
Constructively progress to outcomes despite uncertainty or ambiguity
Inspire change, efficiency, and strong cross-functional relationships
Excellent verbal and written communication
Ability to drive continuous improvements
Thrive
Some of the vast rewards of working here
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.
Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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