Responsible Person, GDP Operational Quality Senior Manager
Vertex Pharmaceuticals
- Brussel
- Vast
- Voltijds
- Build strong working relationships with International Supply Chain, Regulatory, Technical Operations and the Global quality functions.
- Work cross-functionally with all levels to foster exceptional collaboration.
- In cooperation with International QA team, establishes and maintains corporate quality objectives, actively promotes an effective quality management system (QMS) in Belgium and the Netherlands.
- Effectively fulfils the role requirements of the Responsible Person for Vertex Pharmaceuticals (Belgium) and Vertex Pharmaceuticals (Netherlands)
- Responsible for maintaining the Warehouse and Distribution Authorization
- Perform RP duties as per GDP guidelines by; ensuring that a quality management system is implemented and maintained; focusing on the management of authorised activities and the accuracy and quality of records; ensuring that initial and continuous training programmes are implemented and maintained; coordinating and promptly performing any recall operations for medicinal products; ensuring that relevant customer complaints are dealt with effectively; ensuring that suppliers and customers are approved; approving any subcontracted activities which may impact on GDP; ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place; keeping appropriate records of any delegated duties; performing the ‘administrative release’ of batches to the Belgian market in compliance with the local regulations deciding on the final disposition of returned, rejected, recalled, or falsified products; approving any returns to saleable stock; ensuring that any additional requirements imposed on certain products by national law are adhered to; Supervision and management of (product quality) complaints in compliance with procedures and local regulations as well as supervision of logistic complaints; Act as first point of contact towards the competent authorities in quality related matters, including suspected falsified medicinal products Be involved in any decision to quarantine or dispose recalled or falsified products and authorize the disposition of returned medicinal products; Prepare and guide GDP inspections or audits Supervision/management of both self-inspections and external audit programs Ensure permanent availability to the health authorities; in case of absence, delegate his/her duties and keep appropriate records relating to any delegation.
- Provide QA oversight of all GDP activities in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
- Build effective relationships with 3PL QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
- In cooperation with supply chain, ensure that Vertex Pharmaceuticals (Europe) Limited supply chain maps are maintained for all distribution channels, including export countries.
- Proactively partner with other commercial departments to ensure quality aspects of new launches are properly handled. Set up effective collaborations with functional areas such as Regulatory, Supply Chain, local country manager.
- Lead local affiliate Management Reviews.
- Provide guidance and monitor quality issues related to products and GDP to resolution within the company and with external parties including escalation to senior management where applicable.
- Raise and review documentation including change controls, deviations, CAPAs, SOPs and specifications relating to distribution activities. Provide training if required.
- Maintain, review, and update Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
- Ensure Quality Technical Agreements are in place for all outsourced activities.
- Ensure supplier audits are performed as per scheduled frequency, participating as lead auditor/audit team member, where required.
- Contribute to defining standard GDP quality KPIs and to review quality indicators with recommendation for actions for improvement.
- Host inspections by local Health Authorities.
- Provide support to third party warehouse activities from a quality perspective.
- Assess impact and communicate Regulatory Intelligence information. Provide advice to senior management when required and must have personal knowledge of all the relevant GDP guidelines.
- Maintain knowledge of global regulatory requirements for cell and gene therapy products and ensure compliance.
- Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.
- Strong leadership skills with the ability to thrive a fast paced, evolving environment
- Developing individuals and teams; proven leadership capabilities within multi-level organization
- Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
- Root Cause Analysis tools/methodology
- Sense of urgency- ability to act quickly/escalation process/transparency
- Attention to detail
- Master’s degree and extensive relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and extensive years of relevant work experience, or relevant comparable background.
- Eligible to act as the Responsible Person in Belgium and the Netherlands.
- Degree in pharmacy, chemistry, medicine, biology, or a related life science
- GDP & GMP work experience, or relevant comparable background.
- Experienced Lead Auditor
- Fluency in English is required
- Resident in Belgium