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

Luogo di lavoro

Location: WEST MILAN

Please send your CV and motivation letter for the role to: [email protected]

Ref: Quality Unit Manager and Qualified Person Sterile

If not in possession of all the requirements, indicate as reference: SELF-CANDIDATURE

Applications submitted online will be contacted within 30 days of receipt.

Thanks in advance to all those who send us their CVs. In case of failure to call, we will consider the professional profile for any future needs.