R&D and PV Compliance Lead M/V/X

Beschrijving van de functie

Brabant Wallon - Contracting

Our partner is looking for an R&D and PV Compliance Lead to join its team. This international company is well known for its pharmaceuticals.
Manage GCP/GLP deviations and CAPA process according to RDPV Quality End-to-End Deviation Management process: Identify quality issues that would classify as deviation events and facilitate the deviation investigation and root-cause analysis. Enter and Manage Deviations and CAPA as per Source Quality (Veeva System) Deviation management processes. Assess proposed CAPA of vendors and liaise with Process Owners, Subject matter experts (Quality or business) to ensure robust CAPAs are developed and negotiate the major observations with vendors or the company business partners. Manage, track and facilitate the project management of timely review, evidence evaluation and closure of deviations and associate CAPA's from deviations, audits and inspections. Follow-up with CAPA owners to ensure timely review, approval and closure from deviations, audits and inspections. Support development of Effectiveness Checks and ensure timely approval. Escalate issues early within the company and ensure effective risk-based resolutions are in place. Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions. Conduct analytics and qualitative assessments to identify trends and deliver insights. Develop periodic KPI and reporting to senior management (compliance dashboard). Monitor the quality performance of internal processes, strategic vendors and partners. Maximize the application of AI and machine learning (ML) in deviation management

Jouw profiel

Bachelor's Degree required; Master's Degree preferred in Life Sciences Related Field. Preferable 5 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 3 years in the research, clinical development or Pharmacovigilance domain. Experience with managing non-compliance issues in Quality Management system as per deviation management processes. Familiarity with Veeva QMS system is an asset. Proficient in GCP regulations and applicable regulatory framework. Expertise in another GxP area (GLP/GVP) is an asset. Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles (e.g. risk-based decision making, data integrity) Expertise in managing non-compliance, leading root-cause investigations, robust CAPA development and perform Effectiveness Checks in at least one of the GxPs (i.e. GcP). Expertise in another GxP area (GLP/GVP) is an asset. Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results and expertise working with service providers. Skilled in influencing others within a global matrix organization and driving informed decision - making. Ability to analyse data, perform trend analysis and lead meaningful discussions with business management for meeting compliance requirements. Experience working with data analysis tools and notion of applying AI and Machine Learning in pharmaceutical industry. Capable of prioritizing and focusing on critical issues using a risk-based approach Manages quality and compliance issues with diligence, rigor, transparency and timeliness.

Taalvaardigheden

• Nederlands (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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