25 days old

Quality Director

Amgen
Thousand Oaks, CA 91360
  • Job Code
    120787339
Amgen

Job ID: R-100410
Location: Thousand Oaks, CA, US 91360

Quality Director

Global Post Market Actions and Surveillance

Requisition:

Job Profile: Quality Director

Job Code: 46000346

GCF: 7

Job Summary

Amgen is seeking a Director with responsibility for all Global Post Market Actions and Surveillance at Amgen, reporting directly to the VP Corporate Quality and working closely with the VP Final Product Quality and Surveillance. This position is based in Thousand Oaks, but other Amgen sites may be considered.

The Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve the patients. The Director owns and ensures post market event management quality process is effectively implemented end to end across the global operations network. for efficiently managing post market quality events and surveillance activities globally at Amgen, serving as the global process owner in the strategy and execution of these critical processes.

The Director 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 post market activities. Interfaces directly with agencies during inspections and provides response to agency requests regarding post market and surveillance/complaints processes. Works closely with global regulatory and safety to assure complaints business process is adapted to emerging trends or new requirements in regulations.

Key Responsibilities:
  • Owns and ensures post market event management and surveillance quality processes are effectively implemented end to end across the global Operations Network
  • Effectively manages post market event management and surveillance quality processes to drive an agile, efficient, effective and sustainable Quality Management System
  • Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and escalating to management for support if needed
  • Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit and inspection findings and deviations
  • Leads continuous process improvements and partners with network SMEs on key initiatives
  • Interfaces directly with agencies during inspections and provides response to agency requests
  • Provides leadership and support for regulatory inspections and audits
  • Maintains assigned global quality process in compliance with all applicable global regulations and global Amgen specific requirements
  • Monitors GMP Surveillance and takes necessary actions to align process to applicable new or revised regulatory requirements
  • Leads network and Owns Process Standard, Process Overview and Multisite SOP and ensures alignment with document hierarchy and document templates
  • Cascades requirements and QMS architecture down to all applicable sites and functions. Notifies sites early of changes to ensure consistency.
  • Applies in-depth knowledge and subject matter expertise to determine the steps necessary to advance the quality system to address complaint causes, etc.
  • Provides accurate and robust surveillance information that meets global health authorities and Amgen requirements
  • 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)
  • Contributes to inspection readiness activities
  • Leads cross-functional initiatives
  • Interprets SOPs and regulatory requirements
  • Provides guidance and technical advice to key stakeholders
  • Drives Operational Excellence and champions change


Basic Qualifications

Doctorate degree and 4 years of Quality experience

OR

Master's degree and 7 years of Quality experience

OR

Bachelor's degree and 9 years of Quality experience

Preferred Qualifications
  • 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • 7+ years of leadership experience managing teams across global sites and functions
  • Advanced Degree in a Science Field
  • Combination products expertise
  • Advanced knowledge Quality Management Systems
  • Ability to balance and interpret global priorities and market appropriate requirements to ensure Quality System elements are Agile and phase appropriate
  • Autonomous thinker, willing to take informed and appropriate risks
  • Broad and deep knowledge of the Amgen Quality Management System (QMS)
  • Understand global, regional and local commercial business (speak commercial)
  • 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
  • Familiarity with basic project management tools
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high-quality results
  • Strong aptitude for coaching and providing on-going mentoring and guidance to team
  • 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
  • Working knowledge of applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls)
  • 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


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 focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.



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Posted: 2020-06-11 Expires: 2020-07-12

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Quality Director

Amgen
Thousand Oaks, CA 91360

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