Quality and compliance lead operations

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Quality & Compliance Lead Operations

Location: Geel Belgium
Organization: Johnson & Johnson Innovative Medicine

About the Role

As the Quality & Compliance Lead for Operations you will serve as the single point of contact for quality and compliance within our Chemical Production facility in Geel which manufactures active pharmaceutical ingredients (APIs). You will lead a team of risk management specialists and drive continuous improvement initiatives to ensure compliance with global standards and optimize operational excellence.

This role requires strategic leadership technical expertise and strong collaboration skills to influence change and uphold the highest standards of pharmaceutical manufacturing.

Key Responsibilities

• Manage and develop a team of risk management specialists.

• Act as the primary contact for quality and compliance within the operations department.

• Own and lead Quality Risk Management processes across operations.

• Serve as a change agent implementing clear processes tools and metrics to enhance compliance and efficiency.

• Lead or coach in complex incident investigations FMEAs and CAPA activities.

• Represent operations as a spokesperson during audits.

• Collaborate with internal and external partners to align on compliance strategies.
  

Qualifications
Education:

• Bachelors or Masters degree in Chemical Engineering Process Technology Bioengineering Industrial Engineering Chemistry or equivalent experience.
  

Experience:

• Proven experience in chemical manufacturing and pharmaceutical compliance.
• Strong understanding of quality compliance change management and risk assessment methodologies.
• Knowledge of cross-contamination control and Annex 1 guidelines is highly valued

Skills:

• Excellent project management planning and coordination abilities.
• Strong people management and interpersonal skills including influencing and conflict resolution.
• Ability to work independently make decisions autonomously and deliver results.
• Fluent in English and Dutch (written and verbal).

Required Skills:

Preferred Skills: