Pilot Plant Compliance Expert
J&J Family of Companies
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
**Job Function:**
Quality
**Job Sub** **Function:**
Business Process Quality
**Job Category:**
Professional
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Join the Global Pharmaceutical Product Development and Supply (PPDS) organization within the Therapeutics Development and Supply (TDS) team at Johnson & Johnson. Based in Beerse, Antwerp, Belgium, our development centers span the US, Asia, and Europe, driving the creation of cutting-edge pharmaceutical dosage forms.
**Your Role**
As a Pilot Plant Compliance Expert you will be a key player in our Pharmaceutical Supply and Engineering Sciences (PSES) organization. You will ensure that our organization consistently operates in line with the GMP regulations and internal policies for safety and quality.
You will take process ownership of specific elements of our Compliance Framework and you will act as the bridge between complex regulatory requirements and practical business operations, translating rules into clear, workable guidelines. With your expertise and communication skills, you foster a culture of integrity, accountability, and compliance awareness across our organization.
In this role, you will collaborate within a dynamic, multi-disciplinary team of project and compliance engineers, technology leads, operations partners and QA experts. You’ll take ownership in upgrading and optimizing our drug product technology and manufacturing processes in our state-of-the art drug product Pilot Plant, whilst being exposed to every facet of our business. From engineering and operations to quality and compliance, you’ll be at the heart of it all. The variety of challenges and the breadth of interaction across departments and teams make this an exciting and impactful position.
As a key player of our organization, you will help shape the future of drug product development and clinical manufacturing. Your responsibilities will include:
+ Be the expert and process owner: Develop, implement and monitor GMP compliance policies, processes and internal controls for the drug product Pilot Plant in sync with Supply Chain, Maintenance & Engineering and Quality organizations. Provide support to clinical manufacturing operations through root cause analysis and risk management assessments for non-conformance investigations and process changes/improvements.
+ Collaborate for success: Establish effective working relationships with partnering departments as well as developing new partnerships to optimize processes. Leverage expert groups outside of your own organization to build expertise.
+ Innovate: Challenge the status quo and drive innovation and continuous improvement in compliance and manufacturing processes, ensuring systems, practices and documentation remain efficient, effective and future-proof.
**Your Qualifications**
+ Education & Experience: Master's degree, scientific orientation (pharmaceutical, chemical or biological sciences) with 5+ years of experience in the pharmaceutical industry (pharmaceutical manufacturing, compliance or quality assurance)
+ Detailed knowledge of GxP requirements and regulations
+ Strong analytical and problem-solving skills, with attention to detail
+ Excellent communication skills, both written and verbal
+ High level of integrity, reliability and accountability (deadline oriented)
+ Showing initiative in innovative approaches to challenges in a fast-paced, changing environment
+ Track record of successful working within a matrix environment for interacting with Drug Product Development, Manufacturing, Engineering and Quality
+ Experience with risk management and root cause problem solving tools is an advantage
**Our Offer**
+ Exciting Opportunities: Join an international and dynamic environment that promotes continuous learning and personal growth.
+ Prime Location: Work at a site that encompasses all aspects of drug discovery and development, just a stone’s throw from the vibrant city of Antwerp.
+ Competitive Benefits: Enjoy a competitive salary, on-site sports facilities, health programs, and family benefits that support your well-being.
+ Inclusive Culture: Be part of a diverse team where your opinions are valued, and a healthy work-life balance is a priority.
If you’re ready to take the next step in your career and make a meaningful impact, we want to hear from you!
Confirmar seu email: Enviar Email
Todos os Empregos de J&J Family of Companies