Above Site External Supply Plasma Quality Compliance Lead (f/m/x)


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Job Description

Your Opportunity:

Self Inspection Program Lead:

  • Proactively monitor and review new and revised guidelines and regulations regarding safety and GMP and define implementation strategy and action plans in collaboration with plasma network
  • Ensure a schedule is defined and aligned across all sites, auditor resources are available and trained, audit results are shared for the entire Plasma OpU
  • Share relevant information from External Inspection or Internal Audit with the plasma OpU Self Inspection team
  • Develop strategies to systematically identify and address compliance gaps across the OpU Plasma sites in close collaboration with the operating units
  • Ensure an alignment in the audit strategy / answers within the OpU plasma for the self-inspection program
  • Promote continuous improvement by analyzing audits results to improve Quality standards
  • Support inspections program within the Plasma OpU by performing audits or supporting inspections

Lead Auditor and Compliance Lead for ESPQ:

  • Plan, prepare, coordinate, execute and follow-up external inspections and audits (internal/customer) - Overall inspection coordinator
  • Inspection Readiness: Maintain the plan, provide status update, identify key role plays, coordinate IR-assessments
  • Responsible for top 10 compliance gaps assessment and follow up
  • Support PQR review
  • Establish and maintain Site Master File content
  • Define strategy for tracking and implementation of regulatory commitments
  • Create, review and approve regulatory submission documents
  • Report product quality issues to health authorities in collaboration with Qualified Persons from ESPQ
  • Qualified person back up
  • Coordinate site notifications to the management

Your Skills & Qualifications:

  • Graduated from technical, pharmaceutical, chemical or biological college or university with practical experience of a quality operations function or related area in plasma pharmaceutical industry
  • Qualified Person certification as a must
  • Substantial management experience in the following areas in the pharmaceutical industry: Quality assurance, CAPA, Change Control, Validation, management of regulatory inspections
  • Solid understanding of the requirements for manufacturing, plant utilities, computer systems and project management
  • In depth knowledge of applicable regulations and laws for biological / Plasma products, such as FDA CFR, cGMP, EU GMP, MD, EU Directives and guidelines, ICH
  • At least 3 years of Lead auditor activities
  • Excellent change management and people management skills
  • Comfortable using digital tools and identifying new digital options/use cases
  • Risk management and problem-solving methodology/principles/application
  • Strong communication and technical skills
  • Excellent verbal and written communication skills in English

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position located in Austria will be € 4.439,- gross per month (full time, collective wage agreement for the chemical industry). Salary arrangements for other locations in Europe (Lessins/Amsterdam) might be different and should be discussed separately. The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

Locations

AUT - Wien - Industriestrasse 67

BEL - Lessines, NLD - Netherlands Remote

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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