Quality Assurance GMP Manager

Job Purpose

The Quality Assurance GMP Manager for Investigational Medicinal Products (IMP) and development activities is responsible for ensuring that all production processes and development activities comply with Good Manufacturing Practice (GMP) regulations and regulatory authority requirements. This role oversees quality assurance for experimental products intended for clinical studies and contributes to ensure consistent quality and regulatory compliance throughout the product lifecycle.

Key Responsibilities

•    GMP Supervision and Compliance: Ensure GMP compliance for the production and development activities for IMPs. Collaborate with cross-functional teams (Production, Clinical, Pharmaceutical Technology, Regulatory) to guarantee adherence to GMP guidelines and regulatory requirements.
•    Oversight of Outsourced activities: Oversee and monitor outsourced GMP-related activities, ensuring they meet internal standards and regulatory requirements. Serve as the central point of contact for external manufacturers regarding inquiries, deviations, investigations, and audit observations. Manage key performance indicators (KPIs) for operational Quality Assurance activities related to IMP suppliers.
•    Deviation and CAPA Management: Coordinate and conduct investigations on deviations, out of specification (OOS), out of trend (OOT), and other non-conformities observed during verification processes or development. Define and implement effective corrective and preventive actions (CAPA) and monitor their execution and effectiveness.
•    Change control and complaints management: Ensure change requests and complaints are managed according to the Quality Agreement and Recordati requirements.

•    Quality Agreements: Maintain and revise quality agreements, collaborating with internal stakeholders for adherence, including the Quality Agreements related to Investigator Sponsored Studies).
•    Documentation and Quality Control: Ensure the accurate drafting and maintenance of GMP documentation, including batch records, SOPs, development protocols, and reports. Conduct periodic reviews to ensure the documentation is completeaccurate, and compliant with applicable standards.
•    Auditing and Regulatory Inspections: Plan and conduct internal audits to evaluate GMP compliance in development and production activities for IMPs. Support regulatory inspections (e.g., AIFA, EMA, FDA), coordinate responses to findings, and implement improvements as necessary.
•    Training and Support: Provide continuous training to staff on GMP requirements and best practices to ensure a culture of quality. Ensure the team is updated on evolving regulations and new international guidelines.
•    Process Optimization: Identify areas for improvement in quality-related processes and implement enhancements that increase efficiency, reduce risk, and maintain GMP compliance throughout development activities.

Required Education

Degree in scientific disciplines (Pharmacy, Chemistry, Biotechnology, CTF or similar). A Master's degree or additional training in Quality Assurance or Regulatory Affairs is preferred.

Required Skills and Experience

•    Experience: Minimum 5 years of experience in a Quality Assurance role with a GMP-regulated environment ideally focused on IMP’s or development-stage pharmaceutical products. Strong understanding of GMP requirements specific to investigational and development activities.
•    Technical Skills: Proficient in GMP principles and familiar with European and international regulations governing IMPs and pharmaceutical development (US and EU regulations, especially in Annex 13).. Experience with investigation techniques (e.g., root cause analysis) and CAPA system management.
•    Interpersonal Skills: Excellent communication and collaboration skills with cross-functional teams. Strong analytical mindset, attention to detail, and strong decision-making abilities.

Required Languages

Fluent in Italian and English (both written and spoken) with the ability to manage documentation and interact with international regulatory authorities.