Quality Assurance Manager – R&D

Curium Live Forward; Milano; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading life sciences company in Milan is seeking a Quality Assurance Manager for R&D. Responsibilities include ensuring compliance with quality standards and regulatory requirements, maintaining quality management systems, and overseeing quality aspects related to investigational medicinal products. The ideal candidate should have at least 5 years of quality assurance experience and a strong background in relevant standards and regulations. This position offers opportunities for professional growth within a dynamic environment.

Competenze

• Minimum 5 years of experience in Quality Assurance or Quality Management.
• Strong knowledge of relevant regulations like GCP and GMP.
• Experience in vendor qualification and management.

Mansioni

• Develop and maintain the quality management system for R&D activities.
• Ensure compliance with regulations for R&D projects.
• Plan and lead audits related to R&D activities.

Conoscenze

Quality Assurance

Regulatory Compliance

Pharmacovigilance

Problem-solving

Leadership

Formazione

Degree in a scientific discipline

Descrizione del lavoro

Summary of Position

The Quality Assurance Manager – R&D ensures that all research, development, and validation activities are conducted in full compliance with company quality standards, applicable regulations, and international guidelines. This role leads the implementation and continuous improvement of quality processes within the R&D department, fostering a strong culture of quality and compliance. The role oversees quality aspects related to investigational medicinal products (IMPs), including manufacturing, packaging, labeling, storage, and distribution, as well as pharmacovigilance activities associated with clinical research.

Essential Functions

• Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.).
• Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH, or other industry-specific requirements).
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Clinical Operations, and Pharmacovigilance to ensure proper documentation, data integrity, and reporting.
• Manage quality agreements, ensuring that external partners operate in compliance with regulatory and company requirements.
• Supervise quality oversight of third-party partners involved in the manufacture, packaging, labeling, storage, and transportation of investigational medicinal products (IMPs).
• Oversee and approve validation studies, qualification protocols, and technical documentation related to R&D and clinical supply activities.
• Support pharmacovigilance activities, including the collection, evaluation, and reporting of adverse events, in collaboration with the PV department.
• Ensure training and awareness of R&D and clinical staff on quality, GxP, and safety reporting requirements.
• Plan and lead internal and external audits related to R&D activities, including inspections by regulatory authorities.
• Manage deviations, CAPAs, change controls, and risk assessments within the R&D scope.
• Support and deliver training on quality and compliance topics to R&D staff.
• Contribute to the definition and implementation of strategies for process improvement and quality enhancement.
• To support COM Office during any type of Regulatory Audit
• To be constantly updated on industry regulations and quality news
• To Acts as the archivist of the CMO office, ensuring R&D data is archived as per applicable regulations.

Requirements

• Degree in a scientific discipline (Chemistry, Biotechnology, Pharmacy, Engineering, or equivalent).
• At least 5 years of experience in Quality Assurance or Quality Management, preferably within R&D or technical functions.
• Strong knowledge of relevant standards and regulations (GCP, GVP, GMP, GLP, ISO , ISO , ICH Q10 etc.).
• Proven experience with GMP for IMPs, GCP, and regulatory requirements for clinical research.
• Experience with pharmacovigilance processes and strong familiarity with GVPs, EMA / PV systems and other related compliance requirements.
• Experience in vendor qualification and management, including CMOs and transport / logistics providers.
• Proven experience in managing quality systems, validation activities, and technical documentation.
• Excellent organizational, leadership, and problem-solving skills.
• Fluent in English and another language at least, an additional language knowledge is a plus.

Soft Skills

• Analytical mindset and attention to detail.
• Ability to work effectively in cross-functional teams.
• Proactive attitude and focus on continuous improvement.
• Strong communication and interpersonal skills.