Kirsten Guldentops
Schilde
Summary
Resilient, versatile professional with proven experience in environments that value commitment and teamwork.
My proactive attitude and enthusiasm define me.
I possess strong digital skills and am eager to continue my professional development.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Change Control Manager, Synthetics Manufacturing
J&J Innovative Medicine
02.2025 - Current
- Establish the strategic direction for implementing Change Control programs and processes that support J&J's Supply Chain for direct material suppliers and Contract Development & Manufacturing Organizations (CMOs) involved in commercial products
- Lead a cross-functional team of experts focused on the Change Control processes for raw materials and CMOs
- Ensure that departmental objectives and activities align with the strategic goals of J&J's Digital Organization and Technical Services (DOTS)
- Identify and lead continuous improvement initiatives aimed at enhancing quality, compliance, systems, and processes
- Foster strong partnerships with internal stakeholders, including PES, Procurement, MSAT, DPDS, External Quality, and Planning
Change Control Lead, LM, SM and AT
J&J Innovative Medicine
03.2022 - 01.2025
- Oversee and coordinate the efforts of change facilitators within designated areas of responsibility to ensure resources are allocated effectively in response to business needs
- Maintain oversight of change analytics and facilitate governance processes
- Collaborate with business partners across Biotherapeutics, Synthetics Manufacturing and Advanced Therapies, as well as suppliers and CMOs, to collect essential information (specifications, master documents, validation/qualification materials) and other necessary deliverables for implementing changes
- Recipient of the 2023 MTO Stand Out Award for the PES - Change Control Improvement Program
Change Control Specialist, LM and SM
Janssen Pharmaceutica
08.2020 - 03.2022
- Responsible for the successful and timely execution and completion of supplier-initiated changes that affect Biotherapeutics and/or Synthetics Manufacturing, ensuring adherence to relevant quality standards and procedures
Operations Lead, Liquid and Dry Bulk Chemicals
BASF Antwerp NV
03.2012 - 11.2019
- Responsible for coordinating end-to-end Supply Chain Planning and Operations for liquid and dry bulk barges, as well as sea-going vessels
- Engage in both short-term and long-term planning
- Forecast and manage inventory levels effectively
- Minimize demurrage costs by implementing effective planning strategies
Education
BBA - Administrative Management
Karel De Grote Hogeschool
Antwerp, Belgium 06.2003
Skills
- Strategic decision-making
- Resilient
- Clear and concise communication
- Ability to switch quickly between strategic, tactical and operational tasks
- Process optimization expertise
- Project oversight
Certification
- IATA Dangerous Goods Courses
- VCA Course
- Safety Advisor RID – ADR – ADN – IMDG
- LEAN SIX SIGMA
Languages
English
Bilingual or Proficient (C2)
Dutch
Bilingual or Proficient (C2)
French
Advanced (C1)
German
Advanced (C1)
Timeline
Change Control Manager, Synthetics Manufacturing
J&J Innovative Medicine
02.2025 - Current
Change Control Lead, LM, SM and AT
J&J Innovative Medicine
03.2022 - 01.2025
Change Control Specialist, LM and SM
Janssen Pharmaceutica
08.2020 - 03.2022
Operations Lead, Liquid and Dry Bulk Chemicals
BASF Antwerp NV
03.2012 - 11.2019
BBA - Administrative Management
Karel De Grote Hogeschool
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