We are looking for an enthusiastic and driven colleague who will be leading the Quality Systems and Compliance department for Biotherapeutic and Advanced Therapy 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 for has strategic thinking capabilities and the ability to help define a vision for the future, but is 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. You play a major role in providing advice on Quality topics to all departments, which are part of the Supply chain. The position provides a unique opportunity to work on the latest and future technologies in biopharmaceutical manufacturing, and you will become part of a worldwide network of QA experts within and beyond Janssen.
The team you will be leading :
You will lead & manage the Quality Systems & Compliance team, proactively developing, improving and monitoring GMP compliance and the applicable guidance’s on compliance and quality systems across the Leiden site to enable the accomplishment of the company’s goal of providing high quality products to patients, prescribers and partners and compliance to regulations. You are responsible for the electronic Quality Systems that support these compliance programs.
You manage the development of a long-term vision and strategy for these quality systems (eg Non conformances/ CAPA; GMP training, change control; document management, risk management) in close cooperation with the site and translating these strategies into compliant programs and processes in line with regulations and business expectations.
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 Advanced Therapies (eg Gene Therapy) . Janssen Biologics is part of Johnson & Johnson Innovative Medicines.
To fill this phenomonal new opportunity, we are looking for an enthusiastic and driven colleague who can take up this challenging role as Senior manager Quality Systems and Compliance. The responsibilities and impact YOU will have:
- · You are in charge of the team responsible for all Quality Systems applied at Janssen Biologics. You are responsible for managing and coordinating activities of up to 20 quality associates within Quality Systems & Compliance team. You provide overall leadership and direction to the Quality Systems and Compliance 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 assignment.
- You develop, improve and monitor comprehensive GMP compliant Quality core systems to facilitate the production of high-quality products. You ensure that a monitoring and continuous improvement process is developed and implemented to enable effective and consistent use of the quality system across the site.
- You act as a knowledge center for Compliance subjects, to ensure that the state-of-the-art knowledge and standards are known and rolled out in the organization. You manage the resolution of unexpected complex compliance or quality system issues as they arise.
- You will influence and manage regulatory and corporate expectations and relationships to ensure harmonization & alignment of the site’s core quality systems, plans and programs to maintain GMP compliance in the current and future situation.
- You are responsible for site’s Management Review program including the Quality Metrics program, to ensure and proactively enhance compliance and business performance of the site.
- You manage the development, implementation, and monitoring the effectiveness of NC/CAPA, Change Control and GMP Training programs, processes and execution and administration, to ensure that appropriate compliance levels are maintained in line with regulations and business expectations.
- You manage the development, implementation, and monitoring the effectiveness of GMP Documentation processes and administration, to ensure that appropriate documentation practices are maintained at the site in compliance with regulations and business expectations.
- You manage the user input, implementation, and monitoring the effectiveness of electronic Quality Systems, to ensure that these electronic systems are fit for use and in compliance with regulations and business expectations.
- You are the spokesperson during audits and inspections for Quality System related items.
- You collaborate closely with the QA department and all other GMP departments within the site (Operations, Quality Control, Engineering, Technical Operations, …). You also work directly with J&J Corporate Compliance, RA departments, but also with Regulatory Authorities and 3rd Parties.
You have a Master’s degree (or equivalent) in scientific/technical discipline with 10 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry. You have 5 years’ experience in a Quality leadership role.
You have a deep understanding of current Quality Management principles, GMP and Quality Systems Pharma regulations You have experience with FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals. You are able to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
You have people leadership experience, excellent written and verbal communication skills with an open, collaborative and interactive leadership style. You are a team player and ready to take a stand when necessary.
You demonstrate strategic thinking capabilities and the ability to help define a vision for the future. You are able to translate strategy to execution and drive the organization forward in executing and delivering results. You foster external relationships and visibility in the industry and you partner with regulatory agencies (e.g., IGJ, EMA and FDA).
This is what awaits YOU at J&J: This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about the patients we deliver our medicines, our customers and communities.
At Johnson & Johnson Innovative Medicines our culture enables dynamic and impactful careers. If you consider joining the team, we offer the opportunity to be part of a global market leader in Biotherapeutics and Advanced Therapies who is investing in new products and technologies and with a vision to create a world without disease. You will be working in a dynamic and inspiring working environment with flexible working hours.