Senior QA Manager (m-w-d) (RE-33319061) Marburg

Aplitrak - Marburg an der Lahn - 20-11-2019 zur Vakanz  

EUR90 - EUR120 pro Jahr + keine Angaben

Senior QA Manager (m-w-d) Marburg

Temporary Appointment

 
 

Main Responsibilities and Accountabilities:
 
  • First point of contact for management and authorities for critical compliance and quality issues
  • Lead and conduct risk assessments and define appropriate measure to proactively prevent occurrence of critical compliance and quality issues
  • First point of contact for management and authorities for critical compliance and quality issues
  • Responsibility for a timely investigation of critical compliance and quality issues
  • Acting as project manager for the above major/complex projects, planning, tracking and progress reporting to steering committee on a regular basis.
  • Escalating appropriately if timeliness are at risk.
  • Responsibility for a compliant and thorough investigation of critical compliance and quality issues as well as for the definition of measures to prevent reoccurrence of the issue
  • Leading cross-functional / multi-departmental project team (e.g. SMEs, production, engineering operational excellence, global R&D, Quality, Pharmacovigilance, regulatory) to identify root cause using adequate tools e.g. Kepner Tregoe, as well as to identify appropriate measures and to define required regulatory actions.
  • Preparation and approval of investigation reports and other documents that will be presented to health authorities e.g. BPDRs on critical compliance and quality issues
  • Responsibility for overseeing project to completion, follow-up of measures to prevent reoccurrence of critical compliance and quality issues
  • Track CAPAs, report on progress on a regular basis and escalate appropriately if timelines are at risk
  • Check and ensure effectiveness of measures
  • Responsible for appropriate communication to Health Authorities on critical compliance and quality issues when needed e.g. filing BPDRs, recalls or other field action
  • Lead and conduct risk assessments and define appropriate measure to proactively prevent occurrence of critical compliance and quality issues
 
 

Qualifications:
 
  • A University Degree in a relevant discipline (e.g. Biology, Pharmacy, Chemistry or Engineering)
  • Master degree +6 years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience
  • Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU, German and other regulatory agency guidelines and in manufacturing of biologics
  • Profound professional experience in investigating critical deviations in GMP environment including demonstrated experience with BPDRs and field actions. Excellent knowledge of root cause investigation tools and excellent compliant report writing skills.
  • Profound professional experience in leading major/complex projects and in leading cross-functional / multi-department project teams involving delegation of work. Broad knowledge of project management tools
  • Strong in driving results and prioritization
  • Ensures Accountability
  • Proven ability to collaborate across departments and lead cross-functional teams
  • Effective communication (verbal and in writing), collaborative and negotiation skills with internals and externals
  • Balanced understanding of GMP requirements and operational needs
mehr...

zur Vakanz

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