Senior QA Officer Data Integrity

The Data Integriy Officer will be responsible for implementing and maintaining a Data Integrity Policy within BBio to ensure Data Integrity across BBio’s paper-based and electronic systems in compliance with EU GMP, Annex 11, PIC/S, and CFR 21 Part 11. The Data Integriy Officer will be the process owner and Subject Matter Expert (SME) for Data Integrity to maintain accurate, consistent, and reliable data in the GxP-regulated environments of BBio.

Key responsibilities are:

• Develop, implement and maintain the Data Integrity (DI) Program and Procedures.
• Conduct DI risk and gap assessments with system owners and stakeholders.
• Collaborate with relevant stakeholders (e.g., Ops, QA, IT, QC to embed Data Integrity controls.
• Lead investigations and monitor timely CAPA implementation for data breaches.
• Advise on DI as part of system validation (GAMP5).
• Monitor and challenge paper-based processes and digital systems based on the ALCOA+ principles.
• Provide training and guidance within BBio on Data Integrity.
• Be the SME for DI in regulatory inspections and internal/customer audits.

To be successful in this role, candidates should meet the following requirements

• Bachelor’s / Master’s in Life Sciences, Pharmacy, Biotechnology or related field with strong experience in Data Integrity.
• 5+ years in a GxP-regulated environment.
• Strong knowledge of GxP, Annex 11 and CFR 21 Part 11.
• Understanding of requirements of Data Integrity applicable to process automation and data acquisition systems (e.g., PLC / HMI / SCADA / LIMS).
• Understanding of ALCOA+ principles.

Competencies:

• Accuracy and attention to detail. 
• Proactive, and independent.
• Excellent analytical and communication skills.
• Flexibility and adaptability in a dynamic work environment.
• Strong decision-making and cross-functional collaboration.
• Leadership in strategy, change, and stakeholder engagement.

• A competitive salary in scale 11 within €4.703 - €7.484 based on a working week of 36 hours.
• A mission-driven culture aligned with global health security and pandemic preparedness.
• Competitive compensation package with performance-based incentives.
• Flexible working environment and strong support for personal development.
• Access to world-class technical capabilities through collaboration with SII experts.

Quality Assurance
Onze afdeling Quality Assurance (QA) bewaakt bij ons de kwaliteit binnen de organisatie en zorgt voor
het opzetten en handhaven van de structuur die maakt dat de tests betrouwbaar en compliant zijn.
 

Bilthoven Biologicals is een internationaal biofarmaceutisch productiebedrijf.
Met circa 500 collega's werken we samen aan de productie van vaccins, zoals polio-, difterie-tetanus-polio (DTP) en BCG.
BBio levert vaccins aan onder andere de World Health Organization (WHO) en UNICEF en helpt zo mee aan het wereldwijde programma om polio de wereld uit te helpen.
BBio maakt deel uit van de Poonawalla Group, eigenaar van het Serum Institute of India, de grootste vaccinproducent ter wereld. 
Daarnaast investeert BBio in modernisering en uitbreiding van onze productiecapaciteit.