15h Left: Senior Associate Quality Assurance

Job Description

The Quality Assurance (QA) Contact will work independently to ensure compliance with Quality Agreements, support key partner and supplier assessments, and oversee quality tasks in alignment with GMP/GDP standards. This role will be responsible for ensuring quality standards are met through collaboration with internal teams, external partners, and suppliers, while also driving continuous improvement initiatives and operational excellence across the supply chain and alliance processes.

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:

At Amgen, we are committed to your professional and personal growth. From our competitive benefits to our collaborative culture, we support your journey every step of the way.

- 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.

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