Senior Associate QA, Global Distribution Quality (GDQ)

Position Overview:

Quality Assurance (QA) Contact

The role will also include collaboration with third-party vendors to ensure service level alignment, support for logistics providers, and participation in audits and inspections.

Key Responsibilities:

• Quality Event & Change Control:

• Perform the

  QA Contact role

  on

  Quality Events

  ,

  Change Control

  records,

  Corrective and Preventive Actions (CAPAs)

  , and

  QA triage

  of

  Distribution complaints

  to ensure compliance with regulations.

• End-to-End Process Compliance:

• Work closely with all relevant partners for the

  end-to-end process

  and ensure full

  compliance with GMP (Good Manufacturing Practices)

  and

  GDP (Good Distribution Practices)

  .

• Subject Matter Expert (SME):

• Act as a

  subject matter expert

  for transportation-related

  Quality Processes

  , providing technical and procedural expertise to internal teams.

• 3rd Party Collaboration:

• Collaborate with

  3rd parties

  (e.g., logistics and transportation service providers) to ensure alignment with service levels and to identify opportunities for

  performance improvement

  .

• SOP & Documentation Compliance:

• Prepare, review, and approve

  Standard Operating Procedures (SOPs)

  and other GMP/GDP documentation, ensuring

  compliance

  with corporate, regulatory, and

  Good Manufacturing Practices (cGMP)

  requirements.

• Risk Management:

• Understand and incorporate

  risk management strategies

  into the overall supply chain strategy to mitigate potential risks.

• Provider Oversight:

• Provide support for

  logistics service providers

  and

  transportation service providers

  by overseeing their performance and ensuring service compliance.

• Audit & Inspection Support:

• Support internal/external audits and inspections as part of the audit/inspection team, ensuring adherence to regulatory standards.

• Quality Expertise:

• Provide

  quality expertise

  and guidance to operational staff and cross-functional teams within

  Amgen

  .

• Operational Improvement:

• Take part in

  operational improvement initiatives

  , programs, and projects aimed at enhancing efficiency and compliance.

• Supplier Relationship Management:

• Oversee

  supplier metrics

  , conduct

  performance assessments

  , and manage key documents to maintain strong supplier relationships and identify improvement opportunities.

• Independent Work & Leadership:

• Work with minimal supervision, demonstrating leadership in line with

  Amgen Values

  and

  Leadership Attributes

  .

Qualifications:

Basic Qualifications & Experience:

• Bachelor's degree

  in

  Science

  or

  Engineering

  and 2+ years of professional experience in related fields.

• Understanding of GMP/GDP requirements

  and their application in pharmaceutical logistics.
• Familiarity with logistics processes for

  parcel, transport

  , and

  warehousing providers

  .
• Experience in

  Validation/Qualification

  of processes, equipment, and facilities.
• Strong

  technical writing skills

  , with experience drafting and reviewing documentation.

• Independent, self-starter

  with the ability to work autonomously under pressure and within teams.
• Knowledge of

  GMP/GDP

  and pharmaceutical regulations.
• Energetic, detail-oriented, and highly motivated with a

  can do

  attitude.
• Strong

  change management

  skills.
• Effective

  communication

  skills across all levels of the organization.
• Proficiency with

  Microsoft Office Tools

  (Excel, Word, PowerPoint).
• Ability to

  multi-task

  and

  prioritize

  effectively in a dynamic environment.

What You Can Expect from Us:

Amgen

• Competitive benefits package

  to support your health and well-being.
• A

  collaborative culture

  that encourages continuous learning and career development.
• Opportunities for

  professional growth

  within a leading biopharmaceutical company.