QC Manager Analytical Excellence and Compliance

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

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Job Description:

Within Johnson & Johnson (J&J) Innovative Medicine Supply Chain, we are recruiting a QC Manager Analytical Excellence and Compliance (M/F/X) as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product (DP) Intermediates based in Geel, Belgium.

J&J Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-API and DP used in treatments that improve the health and lifestyle of people worldwide. The Supply Chain Quality (SCQ) team supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-API and DP guaranteeing reliable supplies in compliance with applicable regulations.

As QC Manager you lead a team of QC professionals dedicated to upholding the highest standards of quality and compliance. Reporting to the Head of QC, you will collaborate with local and global partners, including R&D and supply chain experts, to support QC activities for SM-API and DP testing while ensuring full adherence to regulatory standards.

In this role, you will focus on promoting analytical excellence through rigorous lab testing, controls, and effective risk assessment. You will oversee onboarding and continuous training for the QC team, enhancing their analytical skills, improving investigation efficiency, and reducing errors. Your scientific expertise will enable you to implement best practices and innovative solutions, fostering a culture of continuous improvement within the QC organization.

Job Description

• Lead a team of QC professionals by supporting, coaching and developing team members in reaching quality, business and personal objectives.
• Appoint Subject Matter Experts (SMEs) for QC processes and analytical techniques, map competencies, and assist in their qualification.
• Act as SME for specific chromatographic techniques, offering expertise, guidance, and training to ensure the adherence to best practices and the effective transfer of knowledge within QC.
• Lead onboarding, continuous learning, and ensure the successful implementation of training programs to improve compliance, productivity, and reduce errors.
• Lead and improve investigation processes and methodologies, promoting awareness and training in effective root cause analysis.
• Coordinate complex QC investigations by identifying root causes, implementing corrective actions, and preventing recurrence.
• Provide expertise to resolve complex scientific and technical challenges, supporting analytical transfers and QC operations.
• Oversee and ensure timely and accurate quality reporting, including metrics and trends related to QC activities and compliance.
• Conduct quality risk assessments and develop phase-appropriate strategies for the QC portfolio to improve agility and team efficiency while minimizing quality and compliance risks.
• With focus on Quality activities, provide strategic direction and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora. Continuously challenge the status quo by finding opportunities for continuous improvement. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
• Create, review, and revise quality-critical documents, including Lab Investigations, Non-Conformances, CAPAs, and Change Control assessments.
• Review quality agreements, APR/CPV and monitor trends to identify any areas for improvement.
• Remain current in knowledge and skills towards regulatory, pharmacopoeial standards and industry trends.
• Ensure inspection readiness of the QC organisation, act as spokesperson during Health Authority inspections and customer audits, define and ensure timely implementation of action plans.

Job Qualifications

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …), or related field (PhD preferred).
• At least 6 years’ experience in pharma/biopharma (quality, manufacturing, or development).
• Strong leadership skills, with experience in coaching and developing teams.
• Strong knowledge of QC, QA, compliance, analytical (chromatographic and non-chromatographic) techniques, and lab instruments.
• Proactive and results-oriented with strong problem-solving and troubleshooting skills.
• Ability to quickly assimilate new modalities and technologies, perform risk assessments and develop action plans.
• In-depth knowledge in GMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Effective communicator and team player with strong interpersonal skills.
• Ability to partner with and influence others without direct authority.
• Experience with regulatory inspections and preparedness.
• Good written and verbal communication skills in English.