Director Quality Control

Job Description:

J&J Innovative Medicine is recruiting for a Director Quality Control reporting to the Site Quality Head Leiden Biotherapeutics and to be based in Leiden (Netherlands).

Profile summary

Responsible for managing and coordinating the activities of the quality laboratory associates within Site Quality Control, including testing of raw materials, release and stability testing of Intermediates, API and Drug Products manufactured at internal J&J and external third parties for the Large Molecule Platform. Responsible for microbiological (sterility, bioburden, purity and endotoxin) and environmental testing.

Responsible for managing the NPI activities of the Lab associates engaged in primary and secondary analytical method and technology transfers to ensure compliance with quality standards

Ensure compliance with quality standards and production schedules

Essential Job Duties and Responsibilities

• Quality accountable for the Quality control department at Janssen Biologics site in Leiden. Provides overall leadership and direction to the quality control organization, building processes to improve the capabilities of the organization.
• Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
• System Owner for Laboratory Controls
• Full compliance of Site Quality Control with the appropriate regulatory and corporate requirements and with registered dossiers for Large Molecule drugs
• Ensure availability of effective systems for measurements and tracking/trending, to enable monitoring and control of the analytical testing activities
• Support the broader organization/business with knowledge of the product stability of JSC Large Molecule products
• Support the broader organization/business by providing governance via the Large Molecule stability committee to the stability programs in the different development phases of the product
• Drive continuous improvement and implementation of Lean/Business Excellence/JJOS
• Proactive succession planning and high-performance culture through people training, development and targeted assignments
• Manage Site Quality Control testing and release lead times to ensure timely product disposition
• Budget responsibility for Site Quality Control: CAPEX, headcount, CIP and expenses
• Disciplinary responsibility for performance and training and coaching development of all Site Quality Control associates
• Spokesperson during audits and inspections for Site Quality Control related items

Minimum Qualification

• Master’s degree in scientific/technical discipline with 10-15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry
• Relevant experience in people management roles.
• Significant experience in supporting functional area (e.g., R&D, Manufacturing, Engineering, EHS, or Technical Services) preferred.
• Experience & Interaction with FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. A thorough knowledge of GMPs is required. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Excellent written and verbal communication skills with an open, collaborative, interactive leadership style.
• Fluent written and verbally in English
• Demonstrated strategic thinking capabilities and the ability to help define a vision for the future.

Required Skills:

Total Quality Control

Preferred Skills:

Compliance Management, Developing Others, Inclusive Leadership, Leadership, Operational Excellence, Quality Control (QC), Standard Operating Procedure (SOP)