Quality Assurance Project Leader/Drug Product

Contract duration: 31.12.2025

Responsibilities:

• Establish and negotiate Quality Agreements (QAA) in close collaboration with Drug Product Services DPS and Drug Substance (DS) sites (e.g. Slough / Visp).
• Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations. Support and manage interactions in cases of changes, deviations, technical complaints, out of specification results and others.
• Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
• Act as QA representative in Project teams and represent QA in customer meetings during Technical Transfer.
• Act as QA contact for specific projects and realize the interface for DR and CR with the customer (routine follow-up’s).
• Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments.
• Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
• Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI).
• Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs.
• Author, review and approve GMP-relevant documents and SOPs.
• Support continuous improvement programs to establish an effective Quality Management System for Drug Product.
• Support and approve project / product specific risk assessments.

Requirements:

• A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
• 5 years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, particularly in Drug Product manufacturing.
• Extensive experience in negotiating and managing Quality Agreements and customer interactions.
• Strong understanding of GMP, regulatory requirements, and quality systems in the pharmaceutical industry.