QA Manager

Job Purpose

The Quality Assurance Department at Recordati supports manufacturing and worldwide distribution activities of rare diseases and specialty care products according to the applicable quality standards. 

In close collaboration with the QA team and internal stakeholders, the QA Manager will be responsible for the operational quality oversight of drug substance, drug product and finished goods manufacturing performed by external partners. The individual will ensure these processes are kept up to date and in compliance with the current regulations, regulatory dossiers and Recordati standards.

The role holder will be based in our offices either in Hemel Hemsptead in UK or Basel in Switzerland on a hybrid basis

Key Responsibilities

Overall Objective
• Serve as the primary Quality Assurance contact for Recordati products.
• Provide comprehensive Quality Assurance support to internal stakeholders, ensuring business needs are efficiently met.
• Foster strong relationships with both internal and external partners to continuously enhance processes, ensuring product quality and compliance throughout the entire product lifecycle.
Main tasks
• Work in conjunction with technology transfer and CMC to provide QA inputs for transfers, regulatory submission/variation and launches
• Participate in GMP/GDP visits and/or audits as appropriate
• Monitor, evaluate, assess third parties’ performance and compliance according to existing SOPs
• Establish and co-sign Quality Agreements as appropriate
• Review and approve GMP documents from third parties as appropriate
• Initiate/ classify / assess deviations, complaints, changes, CAPAs from manufacturing sites
• Support contracted organization and Recordati affiliates in the conductions of investigations
• Contribute to release activities to ensure timely release by affiliates
• Conduct activities related to APQR

Technical Competencies

• University degree in Pharmacy, Chemistry, Biotechnology or equivalent scientific fields
• Minimum 8 years relevant working experience related to manufacturing (small molecules and/or biotechnology, sterile manufacturing), QC, technology transfer
• Previous experience in quality oversight of contracted manufacturing and/or laboratory organizations
• Knowledge and understanding of US, EU and ICH regulations and industry standards
• Experience in GMP/GDP audits, inspections.
• Good knowledge in IT systems like Veeva, SAP as advantage
• Good oral and written English, additional language as German or French is considered beneficial
• Ability to work independently as well as in a team
• Solution oriented, pragmatic, ability to simplify complexity.
• Excellent review skills and ability to organize and manage multiple tasks in a fast-paced environment.

Required Education

• University degree in Pharmacy, Chemistry or equivalent

Required Skills and Experience

• Min 3-5 years relevant experience preferably in GMP QA and QC
• Good knowledge in IT system like Veeva, SAP as advantage
• Experience in GxP audits, inspections. Certification as an auditor as advantage
• Good oral and written English, German / French as advantage
• Ability to work independently in a matrix environment
• Solution oriented, pragmatic, ability to simplify complexity.
• Excellent review skills and ability to organize and manage multiple tasks in a fast-paced environment.

Required Behaviours and Competencies

Required Languages

English fluent spoken and written

German and/or French as advantage

Travel required in %