Mgr Quality Assurance in the Plant

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Job Description:

We are looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Johnson & Johnson Innovative Medicine (JJIM) in Leiden The Netherlands. Somebody who would like to contribute to a high-quality organization of the site and J&J.

The Manager will be responsible for setting up a Quality in the Plant (QITP) team in order to further strengthen the overall quality status of the site. You will be part of the QA operational commercial product management team and will work in close collaboration with other departments (Operations warehouse QC labs MAM and Technical Operations). 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 J&J. The activities are very dynamic and varied. The candidate likes challenges doesnt avoid problems and enjoys working in various teams.

About the Company:JJIM 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 such as rheumatoid arthritis and psoriasis. JJIM is part of the Johnson & Johnson family of companies. The department Quality Assurance sees to that quality systems are applied as per GMP standards and is responsible for handling non-conformances bulk (PFB / FB) and intermediate (DPC / CSS) release and change addition the department is responsible for providing quality oversight and support during daily operations activities. With that the QA department plays a significant role in providing advice on quality topics to all departments of the supply chain.

We are looking for an enthusiastic and driven colleague who can take up this challenging role as Manager QA. The responsibilities & the impact YOU will have:

• The manager sets up and leads a team of 10-14 QA specialists that work side by side with operations in a 16/7 shift schedule
• Manages leads & motivates the QA OCP department and its people to enhance performance and achieve business goals agreed metrics & budgets
• Be the lead contact for departments we work with
• Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
• Manages and improves the GMP processes to facilitate the production and testing of Commercial products at JJIM
• Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the sites quality systems projects and programs to maintain GMP compliance with special focus on Commercial product manufacturing and compliance.
• Raise serious quality compliance and /or GMP incidents to Site or Global Management.
• Replaces other QA-OCP MT members and the Sr Manager OCP when needed
• Supports inspection readiness programs and manages the process during Quality Regulatory inspections

Kwalificaties - Extern

We would love to hear from YOU if you have the following essential requirements

• University degree at a master level in relevant discipline e.g. biosciences pharmacy analytical chemistry process technology or engineering
• Minimum of 6 years experience in quality and/or similar GMP environment in pharmaceutical consumer or medical device company of which minimum 2 in a managerial people leading role

• Strong quality mentality
• Knowledge of current Quality Management principles GMP and Quality Systems Pharma regulations (cGMP/ICHIFDA/EMA)

• Perfect written and oral communication skills in Dutch and English
• Team player and ready to take a stand when necessary.

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 our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether youre one of the 2000 people who work here or youre considering joining the team we offer:

• Flexible working hours
• Your chance to be part of a global market leader.
• A dynamic and inspiring working environment.
• Opportunities to set up and lead a new team within the quality department

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.