Quality Unit Manager & QP - Sterile Manufacturing

The Company

A pharmaceutical multinational specializing in drug development and manufacturing, with extensive expertise in oncology, is currently seeking a:

Quality Unit Manager & Qualified Person

The candidate will be responsible for:

• Managing the batch disposition process to ensure timely release of the product
• Ensuring the batch disposition process complies with site practices and regulatory requirements
• Supporting major investigations, ensuring all product deviations are closed prior to batch release
• Participating in cross-functional teams as the Quality/Qualified Person representative
• Providing additional QP support to quality-related issues, as the need arises.
• Participating on internal committees/teams, as required
• Providing advice and direction to other departments on quality issues
• Reporting to the Quality Unit site Director, ensuring independence of the QP in decisions on quality-related matters
• Building partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements
• Providing audit support as required for internal auditing programs and supplier audits

Personal Attributes

• Pharmaceutical manufacturing experience in Sterile manufacturing
• Post Graduate Qualification required (MSc or equivalent)
• Ideally 8+ years of cGMP experience with relevant work experience acting as a Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA); consideration will be given to other relevant experience and education
• Experience in managing Health Authority audits, CAPA plans, and related documentation
• Proven leadership skills comparable to 2+ years of management responsibility
• Problem-solving, risk assessment, and impact analysis abilities
• Training/mentoring experience
• Fluency in Italian and English

Location

NORTH-WEST MILAN

Place of work