Thursday , March 4 2021

Quality Manager, Site Lead – Amgen Sales Jobs

Website Amgen

Job Description:

Amgen is searching for a Quality Manager Site Lead who will be responsible for Quality and Compliance Oversight of the External Supplier, this may include contract testing laboratories, contract manufacturing sites or raw material suppliers. The Manager will have responsibility working with supplier quality and manufacturing.

Job Responsibilities:

  • Author and drive actionable site inspection readiness plans
  • Author inspection playbooks with External site on key risks/gaps and drive readiness efforts with External site
  • Representation at Amgen product-specific Regulatory Inspections and/or during Notified Body audits of External site, as applicable or required
  • Identify and mitigate risk at the External site
  • Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
  • Escalate risks or roadblocks to management
  • Drive timely decision-making using DAI principles
  • Drive continuous improvements and Amgen first mindset
  • Perform tactical batch disposition activities in support of lot release
  • Serve as the main Quality point of contact related to Amgen product at External site
  • Manage External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
  • Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
  • Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
  • Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site

Job Requirements:

  • Ability to manage diverse relationships
  • Ability to lead and manage cross-functional teams
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel +/- 10% of time to domestic and international Amgen/External sites
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrix or team environment

Qualification & Experience:

  • Ability to oversee multiple projects simultaneously
  • Able to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • cGMP Experience

Job Details:

Company: Amgen

Vacancy Type:  Full Time

Job Location: Thousand Oaks, CA, US

Application Deadline: N/A

Apply Here