QA R&D - GMP Specialist (Investigational Medicinal Products)

Job Purpose

The Quality Assurance R&D - GMP for Investigational Medicinal Products (IMPs) and Combination products development activities is responsible for ensuring that all manufacturing and development operations comply with applicable GMP regulations, ICH guidelines (Q8, Q9, Q10), Combination Product/Medical Device regulations, and regulatory authority requirements.
The role provides QA oversight of investigational products intended for clinical studies throughout the IMP lifecycle (from early development to clinical phases), as well as applicable Combination Products/Medical Devices, ensuring consistent quality, compliance, and data integrity throughout the product lifecycle.

Key Responsibilities

GMP and Combination product/Medical Device Compliance Oversight:

• Ensure compliance with GMP requirements for IMPs and applicable regulatory requirements for Combination Products/Medical Devices (e.g., EU MDR 2017/745 and/or FDA 21 CFR Part 4 where applicable).
• Apply Quality Risk Management (ICH Q9) principles and collaborate with cross-functional teams (Production, Clinical, Pharmaceutical Development, Regulatory Affairs) to ensure alignment with applicable standards. 

Oversight of Outsourced Activities: 

• Manage and oversee outsourced GMP and Combination product/Medical Device-related activities (CMOs, combination product/device manufacturers, testing labs), ensuring appropriate qualification, quality oversight, and performance monitoring of suppliers involved, and compliance with internal standards and regulatory expectations.
• Act as the primary QA contact for CMOs and external partners. 

Deviation, Investigation and CAPA Management: 

• Lead and coordinate investigations of deviations, out of specification (OOS), out of trend (OOT), and other non-conformities and Combination product/Medical Device-related incidents, observed during verification processes or development.
• Ensure application of risk-based approaches in investigations robust root cause analysis and effective CAPA prioritization in accordance with ICH Q9. 

Change Control and Complaints Management: Ensure change controls and complaints are managed in compliance with internal procedures, Quality Agreements, and regulatory requirements. 

Quality Agreements: Draft, review, and maintain Quality Agreements with third parties, covering both IMP and Combination Product/Medical Device activities, including Investigator Sponsored Studies, ensuring alignment with applicable GMP and GCP requirements where relevant.

Documentation and Data Integrity: Ensure preparation, review, and maintenance of GMP and Combination product/Medical Device documentation (e.g., batch records, SOPs, technical documentation support, protocols, reports) in compliance with regulatory standards and data integrity principles (ALCOA+).

Audits 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.
• Ensure readiness and timely follow-up of observations.

Training and Quality Culture: 

• 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.

Continuous Improvement: 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 a scientific discipline (Pharmacy, Chemistry, Biotechnology, CTF or equivalent). Additional training in Quality Assurance, Regulatory Affairs, or Combination product/Medical Device regulations is a plus. 

Required Skills and Experience

Experience

• Minimum 5 years of experience in Quality Assurance within a GMP-regulated environment.
• Experience with IMPs and exposure to combination products or Combination products/ Medical Devices is strongly preferred.
• Strong knowledge of GMP requirements (including EU GMP Annex 13), ICH Q8/Q9/Q10 guidelines, and familiarity with Combination Product/Medical Device regulations.
• Experience with deviation management, root cause analysis, CAPA systems, and risk management principles
• Qualification as a Qualified Person (QP) according to EU Directive 2001/83/EC or experience supporting QP in batch certification/release of IMPs will be considered a plus
• Experience in batch certification/release of IMPs
• Experience with Medical Device Quality Management Systems (ISO 13485)
• Previous interaction with regulatory authorities and/or Notified Bodies

Interpersonal Skills

• Strong communication and collaboration skills, with the ability to work cross-functionally.
• Analytical mindset, attention to detail, and sound decision-making 

Required Languages

Fluent in Italian and English (written and spoken).