QA Leader

Your responsibility is to ensure compliance to GxP standards and correct implementation of projects and initiatives for the strategic  biopharmaceutical manufacturing site. The projects may include capacity projects, new product introductions, product transfers, quality enhancement programs, risk assessements, site quality system implementation programs and other cross-functional projects where Quality leadership or stake-holder input is required.

Your Accountabilities include:

• Support the Quality Unit in coordinating and planning the transversal strategic activities (HA inspections and corporate audits, KPI reporting, Quality projects and initiatives)
• Ensures full compliance with Quality requirements (GMP, Corporate Quality Manual, local procedures) and drives for homogeneous and consistent application at site level
• Manage the implementation of internal Policies to ensure quality processes are maintained and current to ensure compliance with regulatory standards
• Coordinate the generation and monitor the execution of the Site Quality Plans, Site Quality Risk Assessments and other relevant gap assessments
• Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are correctly executed and adequate CAPAs are defined, and proper follow up of CAPAs effectiveness. Lead the Site Deviation Review Board
• Keep current in knowledge of applicable GxP requirements.  Survey regulatory landscape and report initiatives and trends to Group QS
• Based on benchmarking efforts, internal surveys, best practices, and emerging trends, provides and co-ordinates input for GMP Quality Manual to Group Quality
• Confirm implementation of QM and other quality initiative from Group QS
• Leads or participates in Quality projects, e.g. Harmonization projects, Implementation of QA processes and tools.

Your Profile:

• Advanced degree in Natural Sciences, or related studies
• Fluent English; French or German would be a plus
• Over 10 years experience in an operational GMP area in manufacturing /development or QA
• Knowledge in biotechnology/ pharmaceutical technology
• Sound scientific, technical and regulatory knowledge, ideally in biopharmaceuticals
• Expertise in cGMP and applicable guidelines,
• Expertise in validation (process and cleaning) would be a benefit
• Proven ability to analyse and evaluate GMP compliance
• Proven ability to influence people and communicate in a process-oriented organisation

If this role appeals to you and you have the corresponding profile, please do not hesitate to apply to us either through the online portal or via email.

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