Career Category

Job Description

Role Description:

• Quality Professional with background and experience in Regulatory and Compliance for Drug Substance manufacture.
• Quality Management System – Audit and Inspection Subject Matter Expert
  • Oversee, implement and administer Amgen’s corporate compliance programs & policies and International compliance standards & procedures as the Audit and Inspection Subject Matter on site
  • Attends collaboration group meetings and represents site/functional challenges, lessons learned, audit and inspection findings and best practices
  • Represents ASM in process design and improvement initiatives of the Global Process Owners (GPO)
  • Maintain the associated Site Performance Metrics and escalates performance issues and trends to the GPO, site management reviews, applicable SMEs and site/functional/regional management.
  • Trains & coaches local end user community

• Inspection -
  • Execute Inspection Readiness Plan for Domestic and International Regulatory Inspections,
  • Maintain Site Inspection Readiness
  • Execute and track Inspection Commitment Applicability Assessments
  • Lead (and in coordination with relevant functions) Inspection corrective action implementation and related improvement action implementation.
  • Follow up on Site Inspection Commitments to ensure timely closure and adequacy

• Audits –
  • Plan and Execute Internal Audit program through leading and participating in site specific or multisite internal audits

• Regulatory -
  • Participate in compilation of  information for regulatory filings (INDs, BLAs, NDAs, other applications and supplements/amendments).
  • Maintain Site Master File

• Annual Product Quality -
  • Consolidate Product Quality reports for Product Quality Lead

• General -
  • Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
  • Provides evaluation and delivery of compliance input on site nonconformance investigations, change controls and/or CAPAs. In addition, review of cGMP documents to ensure changes cause not impact to site regulatory commitments
  • Participate in global networks and initiatives

Education / Licenses

• Degree in Chemistry, Chemical Engineering Science or related technological field
• Doctorate degree in Science and 3 years of directly related experience OR
• Master’s degree in Science and 3-4 years of directly related experience OR
• Undergraduate degree in Science and 6-8 years of directly related experience

 Relevant Experience

•  6-8+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry

Competencies / Skills

• Previous exposure to bulk drug and drug product manufacturing processes
• Knowledge of GxP Regulations and industry standards such as thorough working knowledge of EU and US cGMPs.
• cGMP auditing and regulatory inspection experience
• Demonstrated ability to coordinate multi-functional project teams and deliver on schedule.
• Leadership skills to influence across the sites, functions or regions
• Excellent interpersonal relationship skills with excellent oral and written communication skills.
• Ability to work independently and as a team player.
• Demonstrated ability to deliver results through living the Amgen values is necessary.
• Negotiation skills when working with contractors and an ability to maintain remote working relationships with team mates at other Amgen sites
• Strong problem solving, organizational and analytical skills
• Experience presenting and managing audits and inspections
• Ability to navigate through ambiguity

Additional Requirements

• To be able to travel

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.