Assistant Manager External Supply Quality | ScaleneWorks INC
Job Description
Assistant Manager - External Supply Quality
Company Overview
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently, and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality, and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions, and artificial intelligence to deliver for patients.
Job Summary
The Assistant Manager - External Supply Quality is responsible for supporting the management and execution of quality assurance processes within the External Supply functions. The role involves effectively coordinating training, managing quality documents, facilitating escalations, and driving risk management initiatives to ensure compliance and high-quality standards are met.
Responsibilities
- Training Coordinator: Manage organizational, personnel, and training documentation including training records and training curricula; identify training needs and develop training plans.
- Quality Escalation Calls: Facilitate weekly escalation calls and Tier meetings; maintain relevant documents and provide updates on deviations and escalations to management.
- Dashboard and Management Slide Packs: Prepare and consolidate quality data and dashboards for management meetings; ensure all KPI targets are achieved.
- CAPA Champion: Track and oversee corrective and preventive actions (CAPAs) within External Supply functions; escalate exceptions and perform annual reviews for continuous improvement.
- RMPO for ES Quality: Conduct risk management meetings and promote a risk management culture; ensure timely escalation of identified risks.
- Quality Alert and Quality Bulletin Coordinator: Review and ensure compliance with Quality Alerts and Bulletins, facilitating necessary updates in governance forums.
- Periodic Product Review: Track compliance actions and provide updates related to the Product Review process.
- Quality & Regulatory Intelligence (QRI) Coordinator: Ensure all relevant QRI communications are assessed for applicability and coordinate the implementation of requirements.
Qualifications
- Educational Background:
- Graduate in Science or Pharmacy discipline.
- Minimum 5 years of experience in the pharmaceutical industry.
- Experience:
- 5+ years in Quality Assurance in pharmaceutical formulations.
- Demonstrated experience in monitoring contract sites and managing product transfers.
- Skills:
- Strong knowledge of documentation, regulatory requirements, and quality management systems.