Job Information
J&J Family of Companies Senior Manager QC Compliance in South Holland, Netherlands
Senior Manager QC Compliance - 2406180407W
Description
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo (https://www.jnj.com/credo/)
Senior Manager QC Compliance (m/f/d)
Location: Leiden, Netherlands
Janssen Biologics is currently recruiting a (Senior) Manager Compliance Quality Control (QC) within our Quality department. The successful candidate needs to have strong knowledge of (Regulatory) Compliance and GMP guidelines in a QC environment and be someone who takes ownership, develops people, builds strong connections, and shapes the compliance and safety culture within QC. You will be reporting to the QC Director Biotherapeutics.
About the Company:
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson that has been for more than 25 years a leader in the field of biomedicines. We continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders, such as rheumatoid arthritis and psoriasis. Janssen Biologics in Leiden is manufacturing key Biotherapeutic products, like Remicade, Stelara, and Simponi, and is also launching new products.
The QC laboratories department in Leiden is part of the supply chain (JSC) organization and is responsible for testing of raw materials, release and stability of Active Pharmaceutical Ingredients and Drug products manufactured at Leiden, other internal J&J sites and at external third parties. Leiden JSC QC is uniquely positioned as the HUB for Stability testing. The lab consists of 1) multiple test teams in a broad spectrum of lab techniques for Biotherapeutics and Advanced Therapies products and 2) support teams focusing on compliance, automation, sample management, Environment Health & Safety (EHS), business excellence and new product introductions.
The responsibilities & the impact YOU will have:
Leading a team of up to 5 compliance and EHS specialists and provide operational guidance.
Act as a Servant Leader to coach and develop team members, driving business performance by successful talent development.
Manage departmental budget, project budgets and resources; prepares staffing plans. Align roles and responsibilities of department to meet business needs.
Setting goals and objectives for the department and define Key Performance Indicators that are indicative for excellent performance.
Ensuring the Biotherapeutics and Advanced Therapies QC groups adhere to compliance, GMP and EHS regulations.
Identifying risks that the organization faces and advise on how to avoid and address missteps that could result in observations and/or safety and quality incidents.
You are responsible for coordinating timely reporting and processing of compliance, quality, and safety incidents.
You are advisor and impact assessor on quality and safety incidents, inspection observations, change controls, gap assessments and other compliance related topics.
Contributes to global strategies related to QC Biotherapeutics and Advanced Therapies laboratories which align with compliance and business objects as well as the overall J&J vision.
You lead internal audits and health agency inspections for the QC JSC Leiden group and are responsible that timely responses are given on any recommendation and/or observations in cooperation with the compliance and Quality department.
You provide compliance trainings and develop lab personnel to be ready for compliance and safety inspections.
You coordinate or perform compliance and safety Gemba walks/spot checks to frequently evaluate lab compliance and to ensure that work on the labs is done on a compliant matter.
Qualifications
We would love to hear from YOU, if you have the following essential requirements:
Masters / PhD or equivalent degree required in Pharmaceutical or life sciences, biotechnology or equivalent.
Profound knowledge of pharmaceutical regulations/cGMP principles
Experience working in a (pharmaceutical) laboratory environment.
Analytical and strategic thinking and (technical) problem solving.
Strong leadership, collaboration and communicating qualities.
Personal and social skills: able to build bridges with Biotherapeutics and Advanced Therapies testing teams, compliance, and quality groups.
Quality and safety mindset
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.
We are passionate about our work; we play vital roles across a range of professional fields and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the 2000 people who work here, or you’re considering joining the team, we offer:
Flexible working hours
Being part of a global market leader.
A dynamic and inspiring working environment, including operating globally.
Opportunities to work on ambitious projects and assignments.
Possibilities for further personal and professional development/education
Janssen Biologics in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Cell & Gene Therapy. We combine our proven strengths with innovation to meet the needs of today and tomorrow. At Janssen Biologics, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and commit to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through pioneering programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization Janssen Biologics (7266)
Job Function Quality Control
Req ID: 2406180407W