About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist, Recent Product Introduction to join our Quality team.
This role is responsible for leading quality activities for multiple Mergers & Acquisitions (M&A;) and New Product Introduction (NPI) projects, identifying and mitigating key quality risks to support successful integration and product launches. Apply strong knowledge of GMP and GDP requirements across the US, UK, EU, and other global markets to ensure compliance. Partnered with cross-functional teams to prevent quality-related delays, enabling on-time project delivery and product commercialization.
What You'll Be Responsible For
Conducting Due Diligence for M&A; and NPI projects from a quality perspective, ensuring:
Identification of gaps during DD and highlighting risks associated with the project
Identification of tasks associated with the project during Integration
Enable a data-driven process that provides ease in determining and reporting identified risks, pending tasks, and overdue actions for project managers and task owners.
Identify risks that can impact the timely launch of product/project and its mitigating actions
Prepare and execute regular monitoring of KPI’s for all M&A; Integrations and NPI for the Quality team.
Support in the management of documents and templates associated with M&A; and NPI from Quality perspective.
Participate actively in cross-functional meetings relating to M&A; and NPI projects from Quality perspective and execute assigned deliverables within agreed timelines.
Leading Bi-weekly / monthly meetings for both M&A; and NPI within Quality.
Other activities that may be required at the discretion of management, supporting Quality activities.
Provide support during inspection by competent authorities.
Review and approve assigned Deviations and CAP