Quality BCM Lead

Make your mark for patients

To strengthen our Global Quality - Digital Quality Industrialization department, we are looking for a talented profile to fill the position of: Quality Business Continuity Lead & Process Data Owner – Braine l’Alleud, Belgium.

About the role

The Quality Continuity Management Lead is responsible for driving Business Continuity Management (BCM) activities across Global Quality, ensuring the resilience and recoverability of critical quality processes, systems, data, and regulatory operations during business disruptions.

In addition, the role acts as Process Data Owner (PDO) and/or Functional System Owner (FSO) for designated Digital Quality solutions, providing business leadership to ensure systems remain compliant, validated, fit-for-purpose, and aligned with business and regulatory requirements.

You will work with

You will be closely working with Quality, Digital Technology, and business stakeholders. This position supports operational resilience, inspection readiness, and Digital Quality Transformation through effective continuity management and digital system stewardship.

What you will do

Business Continuity Management

• · Act as the primary Business Continuity Management representative for Global Quality, ensuring alignment with Enterprise BCM governance, standards, methodologies, tools and resilience requirements.
• · Support Quality process owners in the development, maintenance, and periodic review of Business Continuity Plans (BCPs) and Business Impact Analyses (BIAs) for critical Quality activities, processes, systems, and services.
• · Coordinate continuity risk assessments and ensure key threats, vulnerabilities, dependencies, and recovery priorities are identified and appropriately addressed through appropriate mitigation and remediation plans.
• · Drive the prioritization, follow-up, and closure of identified BCM gaps, mitigation actions, and risk remediation plans through Quality governance processes.
• · Act as the BCM coordination point for Global Quality during continuity events, exercises, or BCM activations, ensuring effective communication and stakeholder alignment.
• · Coordinate BCM exercises critical Quality Processes, simulations, and recovery testing activities, ensuring lessons learned and improvement actions are documented and tracked to completion.
• · Ensure BCM compliance, audit readiness, inspection readiness, and maintenance of BCM documentation, records, and reporting metrics.
• · Foster a culture of resilience and continuous improvement by partnering with Enterprise BCM, Quality stakeholders, Digital Technology, and Risk Management communities to strengthen organizational preparedness and recovery capabilities.

Process Data Owner (PDO) / Functional System Owner (FSO)

• · Act as Process Data Owner (PDO) and/or Functional System Owner (FSO) for assigned Quality digital solutions.
• · Collaborate with Corporate Process Owners, Digital Technology System Owners, business stakeholders, and vendors to ensure digital solutions effectively support Quality processes and business objectives.
• · Provide business stewardship and lifecycle management for assigned solutions, including deployment, adoption, validation, enhancements, integrations, change management, and continuous improvement.
• · Ensure assigned digital solutions remain compliant, validated, fit-for-purpose, and aligned with applicable Quality, GxP, Data Integrity, and regulatory requirements.
• · Maintain business requirements, governance documentation, SOPs, and associated Quality records, while supporting audits, inspections, deviations, investigations, CAPAs, and change controls.
• · Drive innovation, reporting capabilities, data-driven decision-making, and adoption of emerging technologies, including AI-enabled solutions, to improve efficiency, compliance, and business value.

Interested? For this position you’ll need the following education, experience and skills

• · Bachelor’s or master’s degree or an education in a relevant scientific discipline
• · Minimum 5 years of experience in Quality, GxP, Business Continuity, Digital Quality, Regulatory Compliance, or related areas within the pharmaceutical, biotechnology, medical device, or healthcare industries.
• · Experience with computerized system lifecycle management, validation, or digital transformation initiatives.
• · Experience in Business Continuity Management and operational resilience programs. Exposure to BCM frameworks (e.g., ISO 22301) and regulatory compliance requirements is a plus.
• · Experience with Business Impact Analysis (BIA), risk assessments, and continuity planning/exercises.
• · Familiarity with BCM tools or platforms and basic data analysis (Excel, Power BI, etc.) is a plus.
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