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).

Responsibilities

• Manage and coordinate 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.
• Oversee microbiological (sterility, bioburden, purity and endotoxin) and environmental testing.
• Manage the NPI activities of the Lab associates engaged in primary and secondary analytical method and technology transfers to ensure compliance with quality standards and production schedules.
• Serve as quality accountable for the Quality control department at Janssen Biologics site in Leiden.
• Provide overall leadership and direction to the quality control organization, building processes to improve the capabilities of the organization.
• Ensure compliance with GMP, EHS and SOX requirements and guidelines.
• Act as System Owner for Laboratory Controls and ensure 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.
• Provide 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.
• Plan succession and foster a high‑performance culture through people training, development and targeted assignments.
• Manage Site Quality Control testing and release lead times to ensure timely product disposition.
• Hold 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.
• Serve as spokesperson during audits and inspections for Site Quality Control related items.

Qualifications

• Master’s degree in a scientific or technical discipline.
• 10–15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry.
• Relevant experience in people management roles.
• Significant experience supporting functional areas such as R&D, Manufacturing, Engineering, EHS, or Technical Services is preferred.
• Experience interacting with FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
• A thorough knowledge of GMPs and the 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 verbal English.
• Demonstrated strategic thinking capabilities and the ability to help define a vision for the future.

Required Skills

• Quality Control (QC).

Preferred Skills

• Developing Others.
• Quality Standards.

Pay Range

€101000,00 – €174800,00.

Benefits

• Annual bonus with set target (% of pay) depending on pay grade/location.
• Vacation days and parental leave for a minimum of 12 weeks.
• Bereavement leave, caregiver leave, volunteer leave, and well‑being reimbursement programs.
• Financial, physical and mental health programs.
• Service anniversary and recognition awards.
• Participation in various insurance plans (subject to plan terms and eligibility).