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Senior Associate QA, Global Distribution Quality
4 weeks ago
We are seeking a highly motivated individual to join our Global Distribution Quality (GDQ) team as a Senior Associate QA. This is an exciting opportunity to join a team of quality professionals who oversee global product distribution and transportation. The ideal candidate will be a subject matter expert in transportation-related Quality Processes and will provide QA oversight for Global Supply Chain operations. You will be responsible for ensuring compliance with GMP/GDP regulations, collaborating with third-party logistics providers, and driving continuous improvement initiatives.
Roles & Responsibilities
- Quality Oversight & Compliance: Act as the QA Contact for Quality Events, Change Control, CAPA, and Distribution complaints. You will work closely with all relevant collaborators to ensure end-to-end process compliance with GMP/GDP regulations.
- Process Management: Act as a subject matter expert (SME) for transportation-related Quality Processes. You will prepare, review, and approve SOPs and other GMP/GDP documentation to ensure alignment with corporate and regulatory requirements.
- Third-Party Collaboration: Collaborate with third parties to ensure adherence to service levels and identify opportunities for performance improvement. You will also provide support for logistic and transportation service provider oversight.
- Risk Management & Audits: Understand and incorporate risk management strategies into the overall supply chain strategy. You will support tactical activities for internal and external audits and inspections.
- Continuous Improvement: Take part in operational improvement initiatives, programs, and projects. You will also own supplier metrics and performance assessments to inform the health of supplier relationships.
Technical Skills
- Strong understanding of GMP/GDP requirements and pharmaceutical regulations.
- Familiarity with logistics processes for parcel, transport, and warehousing providers.
- Experience in Validation/Qualification of processes, equipment, and facilities.
- Strong technical writing skills.
- Experience with Microsoft Office Tools, including Excel, Word, and PowerPoint.
Qualifications
- A Bachelor's degree in science or engineering with professional experience in related fields.
- Strong continuous improvement attitude and lean practices experience is 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 process understanding and insight.
- 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. This role may require working in shifts or extended hours.
