Quality Management Lead - Pharmacovigilance & Regulatory Affairs - any Galapagos location

Conteúdo do emprego

Pleased to meet you, we are Galapagos,a dynamic fast growing Biotech company. We’re in the business of changing lives.Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives.We are looking for a Quality Management Lead Pharmacovigilance & Regulatory AffairsScope of the jobThe Quality Management Lead Pharmacovigilance & Regulatory Affairs is responsible for the quality assurance oversight on Galapagos Medical Safety and Regulatory Affairs (RA) activities, covering all Therapeutic Areas. These activities include the internal processes and quality systems on a global and affiliate level. The role also monitors the Medical Safety and RA processes and activities through periodic risk assessment, qualification assessment and provides ongoing support to the business in the review and approval of quality events and management of procedural documents.Your role

• Build GVP compliance awareness throughout the Quality Management, Medical Safety and Affiliate organizations:
• Ensure compliance of the pharmacovigilance quality management system
• Build and maintain strong cross-functional collaborative working relationships.
• Drive continuous quality compliance by acting as an internal quality single point of contact (SPOC) on relevant processes, procedural documents and regulations to ensure correct interpretation and implementation.
• Escalate quality / compliance / privacy issues and drive investigation.
• Drive Quality Management Review (QMR) Level 1 meetings
• Through active participation in the Safety Board meeting discussing the functioning of the PV system and through direct interaction with colleagues, escalate concerns and provide expert guidance on PV compliance issues to support the development and implementation of necessary CAPAs and quality improvement measures.
• Perform quality oversight on Pharmacovigilance Site Master File (PSMF)
• Act as a quality ambassador (also for QMS) and advocate for QM processes changes and implementation.
• Drive PV & RA related quality events:
• Drive root cause analysis, impact assessment, CAPA definition and approval of quality events related to the PV system or Regulatory Affairs
• Collaborate to audit & inspection activities:
• Co-Drive the preparation, execution and follow up of Regulatory Authority inspections related to clinical safety and Pharmacovigilance activities at the Central sites, and Affiliates as deemed necessary and practicable.
• Drive the business stakeholders to ensure proper CAPA formulation and timely CAPA implementation and follow-up.
• Ensure effective implementation of PV & RA procedural documents:
• Contribute to the creation, revision and approval of procedural documents (ensuring compliance to applicable regulations)
• Drive quality risk management activities (analysis, evaluation, control & communication related to GVP)
• Interact with the QPPV or assigned delegate to perform the activities mentioned above. Inform the QPPV of (potential) issues and the general status of the QMS related to pharmacovigilance.

Who are you?

• More than 5 years of direct experience in GVP or PVQA in either global or affiliate roles
• Experience in GVP audits or inspections
• Education: Master’s degree in a scientific discipline or equivalent by education and experience
• Experience: More than 10 years’ experience in the Pharmaceutical or Biotechnology industry with a minimum of 5 years in a Quality Management environment

General Skills

• Current and strong knowledge of Pharmacovigilance processes requirements according to Good Pharmacovigilance Practices (GVP), European and FDA regulatory requirements in ATMP and pharmaceutical quality management systems.
• Notions of other GxP requirements.
• The ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization, excellent problem solving, and analytical skills, including knowledge of root cause analysis tools / methodologies.
• The ability to create, maintain and report on planning activities

Strong interpersonal skills resulting in an effective (intra- and cross-departmental) team player.

• Self-starter with a high degree of flexibility, assertiveness and excellent communication skills are essential to success. In addition, well-developed problem solving, decision-making and analytical thinking skills are highly desirable.
• Good communication / interpersonal skills and diplomacy are essential to be successful in the role.
• Knowledge of the corporate structure, knowledge of the corporate culture and the organization of the external partners are essential.
• English proficient knowledge is required.

What’s in it for you?You will be part of a fast growing and amazing company within a warm and welcoming team. You will receive support to make your job successful and to develop you further in your career journey. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to contribute to Galapagos’ growth and achieve breakthroughs in pharmaceutical research all towards improving patients’ lives. Galapagos offers a competitive remuneration package and a dynamic work environment.We are Galapagos: together we can make it happen…!