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.Skills Required
Quality Control, Process Improvement, Stakeholder Engagement, Documentation, Risk Management, Microsoft Office Tools