Amgen

Global Process Owner, Management Responsibilities and Risk management

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 21, 2020
Ref
R-90590
Required Education
High School or equivalent
Position Type
Full time
Amgen is seeking a Senior Manager with responsibility for the Global Risk Management activities at Amgen with a strong emphasis on medical device risk management. This Senior Manager will serve as the Global Process Owner and is responsible for defining, implementing and maintaining risk management activities. These activities ensure that product risk is appropriately assessed, documented and mitigated throughout the entire product life cycle. This manager assures systems and processes remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. Trains and coaches SMEs on how to translate and deploy the architecture to the sites or functional groups, as necessary. Works with key internal stakeholders to enable issues resolution. Drives agile, efficient, effective and sustainable processes, KPIs and linkages between all multiple sources of risk management activities. Interfaces directly with agencies during inspections and provides response to agency requests regarding risk management processes. Works closely with global regulatory and safety to assure Amgen's risk management process is adapted to emerging trends or new requirements in regulations.

Key Responsibilities:
  • Owns and ensures risk management activities are effectively implemented end to end across the product lifecycle
  • Provides guidance to other associates on the application of appropriate risk management practices. Works collaboratively with engineering, design, and product teams to ensure successful translation of requirements into products that are safe and effective for user and enrich the overall user experience across Amgen portfolio or programs.
  • Develops procedures which govern all product risk activities. Ensure product risk management procedures and practices incorporate applicable regulations and guidance documents including ICH Q9, ICH Q10, ISO 13485, ISO 14971, 21CFR820, EU MDR IEC 62366, IEC 60601 and IEC 62304
  • Establishes appropriate practices for assessing risk during product development activities. Support preparation of the risk management plan. Support preparation of failure mode effect analysis (FMEA) documents to assess potential risks from various sources. Developed FMEAs shall include those for product design (dFMEA), device use (uFMEA) and supplied components (sFMEAs).
  • Establishes appropriate practices for assessing risk resulting from manufacturing activities. Support preparation of process failure mode effect analysis (pFMEA) documents.
  • Implements practices to update risk management documents throughout the product life cycle. Establish practices for revising FMEAs as appropriate when new information affecting product risk is available. FMEA updates shall include; a) incorporating production quality data into pFMEAs on a continual basis; and b) incorporating customer experience and field data into appropriate risk documents.
  • Supports risk management practices and applicable documentation during internal audits and third-party inspections.
  • Ensures compliance throughout the network: gap assessments, commitments, response to audit and inspection findings and deviations
  • Utilizes expertise and communicates issues and action plans to management, leveraging appropriate quality management systems to escalate per business process, such as Management Review (MR)
  • Drives Operational Excellence and champions change


Basic Qualifications

Doctorate degree and 2 years of Quality experience

OR

Master's degree and 6 years of Quality experience

OR

Bachelor's degree and 8 years of Quality experience

OR
Associate's degree and 10 years of Quality experience
OR
High school diploma / GED and 12 years of Quality experience

Preferred Qualifications
  • 5+ years of quality engineering experience in medical device, biotech or pharmaceutical industry
  • Experience leading medium or large projects at a global level
  • Advanced knowledge regulations pertaining to medical devices and combination products
  • Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate
  • Cultural awareness and dexterity
  • English language fluency- other language skills are an advantage
  • Innovation mindset with aptitude for developing ideas into actionable objectives
  • Leadership skills and the ability to oversee multiple projects simultaneously
  • Able to successfully manage workload to timelines
  • Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience driving decision making
  • Highly skilled at interacting effectively with inspectors and agency regulators
  • Ability to succinctly communicate level of risk, urgency, or impact to the business
  • Ability to travel +/- 20% of time to domestic and international Amgen sites


If 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

Join Us

If 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.