We are seeking a Senior Associate Quality Assurance professional to provide quality oversight for Amgen's alliance partnerships and external supply portfolio. In this vital role, you will be an integral member of cross-functional teams, including External Supply, Business Development, Process Development, and Supply Chain. This position is responsible for ensuring adherence to quality agreements, driving performance improvements, and maintaining compliance with GMP/GDP regulations.
Roles & Responsibilities
- Quality Oversight: Serve as the QA Contact for partners, ensuring adherence to quality agreements and identifying opportunities for performance improvement. You will also perform partner/client assessments for Change Control and Deviation records.
- Compliance & Documentation: Perform Quality tasks in accordance with Quality Agreements, such as supporting partner audits and document revisions. You will also prepare, review, and approve SOPs and other GMP/GDP documentation to ensure compliance with corporate and regulatory requirements.
- Supplier & Alliance Management: Work closely with key stakeholders to ensure the end-to-end process is compliant. You will collaborate with external suppliers and partners and support Due Diligence activities associated with Portfolio Strategy Execution.
- Risk Management & Audits: Understand and incorporate risk management strategy into the overall external supply lifecycle. You will support tactical activities related to internal/external audits and inspections.
- Process Improvement: Participate in operational improvement initiatives, programs, and projects. You will develop solutions that are thorough, practical, and consistent with functional objectives.
Technical Skills
- Strong understanding of GMP/GDP requirements and pharmaceutical regulations.
- Familiarity with raw material compendial testing.
- Experience overseeing the quality of suppliers or external parties.
- Strong technical writing skills and experience with Microsoft Office Tools (Excel, Word, PowerPoint).
- Experience in Alliance Management.
Qualifications
- A Master's degree with relevant experience, a Bachelor's degree with extensive experience, or a Diploma with a substantial background in related fields.
- Strong continuous improvement mindset and lean practices experience are preferred.
- Understanding of end-to-end supply chain business processes is a plus.
- Experience in project management across multiple departments and geographies is preferred.
Soft Skills
- Problem-Solving: Strong analytical and problem-solving skills, with a quick understanding of processes.
- Communication: Effective written and verbal communication skills, with the ability to communicate across all levels of the organization.
- Proactiveness: Independent self-starter, able to work autonomously, under pressure, and as part of a team.
- Attention to Detail: Energetic, detail-oriented, and highly motivated with a can-do outlook.
- Adaptability: Possesses strong change management skills and the ability to multi-task and prioritize effectively.
