Senior Manager QA Projects – Neuchâtel, Switzerland

BioTalent is currently supporting a leading global pharmaceutical CDMO organisation that are seeking a highly motivated and experienced Senior Manager for QA Projects. As the Senior Manager for QA Projects, you will deputise the Site RP and play a pivotal role in ensuring each product complies during the manufacturing, packaging and testing stages.

Key Responsibilities:

• Regulatory Compliance and Project Management: Act as the deputy of the Responsible Person and Qualified Person, ensuring regulatory compliance and serving as the main Quality representative in key projects.
• Coordinate quality activities related to technology transfer, supplier qualification, and manufacturing specifications, while also serving as the point of contact with customers for quality topics.
• Conduct change control assessments and support responses to regulatory authority requests.
• Quality Assurance and Safety: Actively participate in site Quality activities and ensure compliance with workplace safety policies and laws.

Requirements:

• Extensive experience in QA, QC and/or RA in the pharma industry.
• Regulatory Expertise: Deep understanding of cGMPs and regulatory requirements across Swiss, EU, and FDA jurisdictions.
• Drug Development Lifecycle: Proven experience in all phases of drug development, including clinical trials, technology transfer, and product launch.
• Oral Solid Dosage Focus: Strong knowledge of manufacturing, packaging, testing, warehousing, validation, and registration processes for oral solid dosage forms.
• Strategic Leadership: Demonstrated strategic thinking, business acumen, and ability to translate strategies into tactical execution.

This is an excellent opportunity to get involved in a global leader whilst working at the forefront of science with a strong culture of collaboration.

Please apply / email your resume with a convenient time to Duncan.johnston@biotalent.com to have a confidential discussion about this opportunity.