Director Quality Control

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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/businesswithknowledge of the product stability of JSC Large Molecule products

• Support the broader organization/businessby 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

• Masters 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.

The anticipated base pay range for this position is 101.000 EUR to 174.800 EUR on an annual basis and includes 8% holiday allowance

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