Director Quality Control

Director Quality Control

Location: Leiden, Netherlands Contract: Full Time/Contract

We are looking for an enthusiastic and driven colleague who will be leading the Quality Control department for Biotherapeutic Products at Janssen Biologics in Leiden.

Somebody who has a passion to deliver a high quality organization and has strong people leadership skills. The candidate we are looking has strategic thinking capabilities and the ability to help define a vision for the future, but also able to translate strategy to execution and drive the organization forward in operational excellence. The activities are very dynamic and varied and the candidate likes challenges and enjoys working in various teams.

You will be part of a dynamic Quality team, reporting to the Site Quality head and a key member to the Site Leadership team.

The department you will be leading:

The Laboratory Control department in Leiden is responsible for testing of raw materials, release and stability testing of Intermediates, Active Pharmaceutical Ingredients and Drug Products which are manufactured at internal J&J sites and at external third parties within the Large Molecule Platform. The lab has multiple test teams in a broad spectrum of lab techniques for Biotherapeutic products like Separations Lab, Bioassay Lab, Microbiology and Myco/AVA lab, Chemical and Physical test Lab and supportive Lab Services Team and Release, Stability and New product Introduction Coordination team. Also in the lab multiple new products and technologies are being introduced leading to further Lab expansion in the Bioscience park area in Leiden . 

About the Company: Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics in Leiden is manufacturing key Biotherapeutics products, like Remicade, Simponi and Stelara, but is also introducing and launching new products in the area of cancer treatments and Vaccines. Janssen Biologics is part of the Johnson & Johnson family of companies.

To fill in this phenomenal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as Director Quality Control. The responsibilities & the impact YOU will have:

• You are responsible for managing and coordinating the activities of up to 300 quality laboratory associates within Site Quality Control.
• You are responsible for the team responsible for testing of commercial products and managing the NPI activities of the Lab associates engaged in primary and secondary analytical method and technology transfers to ensure that new products are onboarded in the Laboratory.
• You are Quality accountable for the Quality control department at Janssen Biologics site in Leiden. You Provide overall leadership and direction to the quality control organization, building processes to improve the capabilities of the organization. You deliver proactive succession planning and a high-performance culture through people training, coaching, development and targeted assignments.
• You drive full compliance of Site Quality Control with GMP regulations, the appropriate regulatory and corporate requirements and with registered dossiers for Large Molecule drugs.
• You are responsible for Managing Site Quality Control testing and release lead times to ensure timely product disposition. You ensure availability of effective systems for measurements and tracking/trending, to enable monitoring and control of the analytical testing activities. You drive continuous improvement and implementation of Lean and Business Excellence and you are responsible for the Site Quality Control Budget.
• You 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 and you
• You are the spokesperson during audits and inspections for Site Quality Control related items and the spokesperson for the Quality Control Department in the Leiden Site Leadership team.
• You collaborate closely with the QA department and all other departments in the site (Operations, Engineering, Technical Operations, Human resources , IT, Finance, …). You also work directly with the Global Analytical Development Organization, Third Parties, Contract Manufacturing sites, External service departments, Contract Labs and External quality, but also with Regulatory Authorities and 3 rd Parties.