Senior Manufacturing Validation Lead — GMP & Quality

R Dpartners; Geel; Vor Ort; EUR 83.000 - 101.000; Vollzeit

Zusammenfassung

R&D Partners is seeking a Manufacturing Validation Lead to oversee validation activities for transport and CMO-manufactured products. You will lead validation lifecycle efforts, ensuring GMP/GDP compliance and acting as a quality SME for regulatory submissions and audits.

Based in Belgium, the role requires collaboration with cross-functional teams, focus on Facilities, Utilities and Equipment, Process Validation, and Comparability, and fluency in English to communicate with US-based teams when

Qualifikationen

• Expertise in validation lifecycle approaches and risk-based qualifications.
• In-depth experience in equipment qualification, requalification, and shipping validation.
• Strong knowledge of cGMP, ISO13485, and MDSAP standards.
• Excellent oral and written communication skills in English, with attention to detail.
• Strong interpersonal, negotiation, and organizational skills.
• Ability to work independently and make informed decisions.
• Proficiency in digital tools and project management.
• Experience working with US-based teams is a plus.

Aufgaben

• Develop, review, approve, and execute transport validation plans, protocols, risk assessments, and reports.
• Review and approve CMO-generated qualification and validation protocols, data, and reports.
• Provide onsite or remote support during CMO study execution.
• Assess validation impacts from change controls, deviations, audit findings, and CAPAs.
• Support lifecycle management for CMO-manufactured products.
• Act as a Quality validation SME for regulatory submissions and Health Authority queries.
• Ensure compliance with worldwide regulatory requirements and corporate standards.
• Participate in internal and external audits as a validation quality SME.
• Contribute to Communities of Practice (COP) focused on FUE, Process Validation, and related areas.

Kenntnisse

Validation lifecycle

Risk-based qualification

Equipment qualification

GMP/GDP knowledge

English communication

Project management

Cross-functional collaboration

Independent decision making

US team collaboration

Jobbeschreibung

R&D Partners is seeking a Manufacturing Validation Lead to oversee validation activities for transport and CMO-manufactured products. You will lead validation lifecycle efforts, ensuring GMP/GDP compliance and acting as a quality SME for regulatory submissions and audits.

Based in Belgium, the role requires collaboration with cross-functional teams, focus on Facilities, Utilities and Equipment, Process Validation, and Comparability, and fluency in English to communicate with US-based teams when