Quality Assurance Specialist (m/f/d)

• Manage activities supporting the global release of drug substances, products, and intermediates, including documentation approval, batch record review, investigations resolution, and change control assessment in collaboration with CMOs.
• Drive QA topics and serve as the main liaison for partner collaboration in development activities.
• Ensure compliance with Quality Assurance standards throughout the lifecycle of drug substances, products, and combination products.
• Supervise the GMP/GDP Development QA group within the Quality Assurance department.
• Conduct quality assessments during supplier/CMO evaluations.
• Lead issue resolution and QA review for CMC teams and Supply chain stakeholders.
• Initiate quality improvement initiatives internally or through CMOs.
• Manage investigations of complaints at CMO level and ensure timely completion.
• Implement relevant quality agreements and manage communication with QA peers from partner companies.
• Ensure a GMP/GDP compliant supply chain and GxP environment qualification status.
• Write, edit, assess, and approve relevant regulatory documents and support audits.
• Actively support the organization in regulatory requirements, technology, and training.
• Provide technical and compliance guidance on deviations, investigations, CAPAs, and change control.
• Review, evaluate, and approve deviations, CAPAs, and testing issues.
• Monitor the efficiency of the pharmaceutical quality system (PQS), establish relevant KPIs, and implement improvements as needed.

• Advanced University degree in Pharmacy, Chemistry, or a related technical/science field.
• Minimum of 10 years of experience in pharmaceutical manufacturing, with at least 5 years in Quality Assurance or Quality Control roles.
• Proven track record of managing Health Authorities inspections, conducting risk assessments, and effectively managing CAPAs.
• Comprehensive knowledge of pharmaceutical manufacturing processes, spanning both development and commercial stages, as well as expertise in the control of drug substances, drug products, and combination products.
• Demonstrated experience in leading cross-functional teams.
• Thorough understanding of (c)GMP/GDP and relevant international regulatory requirements, with the ability to accurately interpret and implement quality standards.
• Excellent verbal and written communication skills, with the ability to communicate clearly and professionally.

NES Fircroft