Head of External Clinical Supply Quality H/F/X

Description de la fonction

Contracting - Brabant Wallon

Operational Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc.). Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc. Participate in the management of QA through active participation in QA forums and other meetings. Support in-licensing activities by providing Quality Assurance expertise for the evaluation of new project opportunities including participation in due diligence activities. Support the systems and processes in place for the appropriate documentation of the company development activities and to maintain them in a manner compliant with regulatory and corporate requirements. Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house). Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement). Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions. Provide support in the evaluation of Temperature excursions for IMP. Management of Quality Complaints of IMP Participate in/coordinate escalation of quality topics linked to IMPs supplies Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits. Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc.) Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements Contribute the preparation of audits (internal/external, regulatory inspections) Lead internal audits / Self-Inspections Process Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities. Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions. Ensure Clinical Supply Quality processes directly support Technical Operations and development partner goals and objectives. Review and QA approval of deviations, change controls and complaints. Team Ensure Staff are managed appropriately, have clearly defined roles, are appraised on an annual basis, have clear objectives, work in accordance with HSE and corporate policy requirements and are developed and trained to meet the need of the business and professional career development. Oversee resolution of staff-related performance issues.

Profil

Master's degree in Sciences Certified auditor by official authorities is an asset Technical Expertise: Excellent knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese). Extensive experience in a pharmaceutical regulated environment. Must be knowledgeable in QA and technical requirements of pharmaceutical development processes. A complete understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential. Experience in conducting customer/vendor audits and managing regulatory inspections QA/compliance experience in manufacturing, facility operation, and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences. Leadership & Management Skills: Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments. Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels. Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent. Root cause and risk management/assessment skills. Must be fluent in English and French, other languages are a bonus.

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

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