Senior Associate Quality Assurance - Global Supply Quality

Quality Assurance (QA) Contact

Key Responsibilities:

• QA Contact Role for Partners:

• Ensure adherence to quality agreements

  with external partners, identifying performance improvement opportunities, and managing supplier relationships.

• Partner/Client Assessments:

• Perform partner assessments

  related to

  Change Control

  and

  Deviation records

  , ensuring alignment with quality standards.

• Quality Tasks for Partnership Alliance:

• Perform various QA tasks

  in support of

  Partnership Alliance Quality

  , including document revisions, redactions, and supporting partner audits in accordance with quality agreements.

• Support for Portfolio Strategy Execution:

• Assist with Due Diligence activities

  and other QA responsibilities related to

  Portfolio Strategy Execution

  .

• Process Compliance:

• Collaborate with all key stakeholders for the end-to-end process

  and ensure compliance with

  GMP/GDP

  regulations throughout.

• SOP & Documentation:

• Prepare, review, and approve Standard Operating Procedures (SOPs)

  and other

  GMP/GDP

  documentation in compliance with corporate and regulatory requirements.

• Collaboration with External Suppliers & Partners:

• Partner with external suppliers

  and

  partners

  to ensure alignment with quality expectations and regulatory requirements.

• Risk Management:

• Incorporate risk management strategies

  into the overall

  external supply lifecycle

  to mitigate potential risks.

• Audit & Inspection Support:

• Support tactical activities related to internal/external audits

  and inspections, ensuring compliance with regulatory standards.

• Operational Improvement:

• Participate in operational improvement initiatives

  , programs, and projects that drive efficiency and compliance.

• Business Metrics & Performance Assessments:

• Own business metrics

  , conduct

  performance assessments

  , and manage key documents that reflect the health of

  external supplier

  and

  partner relationships

  .

• Autonomous Work:

• Work under minimal supervision, aligning with Amgen's Values

  and

  Leadership Attributes

  to drive performance and compliance.

Qualifications:

Basic Qualifications:

• Master's degree

  and

  1 to 3 years of experience

  in related fields OR

• Bachelor's degree

  and

  3 to 5 years of experience

  in related fields OR

• Diploma

  and

  7 to 9 years of experience

  in related fields.

• Understanding of GMP/GDP requirements

  and their application in pharmaceutical quality.
• Familiarity with

  raw material compendial testing

  .
• Experience in overseeing the

  quality of suppliers

  or

  external parties

  .
• Strong

  technical writing skills

  with experience in documentation and regulatory compliance.

• Experience in Alliance Management

  , including managing external partnerships and ensuring quality across the supply chain.

Preferred Qualifications:

• Strong

  continuous improvement

  attitude and experience with

  lean practices

  .
• Understanding of

  end-to-end supply chain business processes

  .

• Project management

  experience across multiple departments and geographies.
• Ability to

  quickly understand processes

  , provide insights, and visualize improvements.
• Strong

  analytical and problem-solving skills

  .

• Independent self-starter

  , able to work autonomously and under pressure, while maintaining teamwork.

• GMP/GDP knowledge

  and understanding of

  pharmaceutical regulations

  .
• Energetic,

  detail-oriented

  , and highly motivated with a

  can-do

  attitude.
• Change management skills and the ability to influence and manage organizational change.
• Ability to

  communicate effectively

  at all levels of the organization, both written and verbally.
• Proficiency with

  Microsoft Office Tools

  (Excel, Word, PowerPoint).
• Ability to

  multi-task

  and

  prioritize

  effectively in a fast-paced environment.

What You Can Expect from Us:

Amgen

• Competitive benefits package

  to support your health and well-being.
• Opportunities for

  professional growth

  and career development in a leading biopharmaceutical company.
• A

  collaborative environment

  that values continuous learning and innovation.