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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Beerse, Antwerp, Belgium
Job Description:
We are looking for a driven colleague and team player with a pronounced interest in quality and device assembly and packaging activities, someone who enjoys leading a team and gets energy from developing and maintaining good relationships with our partners.
The Quality Department at the J&J IMSC Beerse site is dedicated to ensuring that all Good Manufacturing Practice (GMP) activities related to manufacturing, packaging, labeling, testing, release, and distribution of products from the Campus Belgium adhere to GMP regulations.
As QA Manager Device assembly and packaging, you are responsible for the product release of a defined product portfolio and have quality oversight for the manufacturing activities performed by your team of QA professionals.
Job Responsibilities:
· Ensure timely release of incoming half-finished product and of produced assembled/final product by performing all required QA release activities (quality investigations, change controls, review (external) manufacturing records,….)
· Ensures key quality deliverables are completed in accordance with required timelines.
· Ensures compliance with global health authority requirements and internal standards.
· Act as spokesperson during Health Authority inspections and customer audits.
· Provides coaching and guidance to team in the identification of risks and development of mitigation plans, monitoring of data, and development of meaningful KPIs
· Is accountable for conducting effective performance management and establishes a culture of continuous improvement, growth, and development.
· Establish and maintain effective working relationships with local and global partners (business, quality, regulatory,…) to ensure alignment of objectives and deliverables
· Continuously challenge the status quo and encourage implementation of initiatives that deliver sustainable improvement in quality and compliance performance
· Manage, coach, and develop a team of Quality associates to achieve their quality, business, and personal objectives.
Job Qualifications:
· You have a scientific degree (chemistry, Pharmaceutical Sciences, bioengineering...) and already have knowledge and experience with cGMP within a chemical or pharmaceutical environment. If you are a licensed industry pharmacist, this is a plus.
· In depth understanding of pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied, qualification, validation, testing, release
· Ability to provide operational leadership to meet business objectives in a highly dynamic business environment
· You have excellent verbal and written communication skills to influence and communicate with your stakeholders.
· You have strong analytical thinking, decision-making and leadership skills.
· You have experience with Quality systems. You understand business implications regarding quality positions and decisions.
· You are able to work in a flexible way under time pressure and make difficult decisions in a timely fashion
· You can work independently while staying connected with partners and global quality leaders.
· You demonstrate an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and you have experience generating effective prompts to boost efficiency and productivity.
**Required Skills: **
Preferred Skills:
Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility
The anticipated base pay range for this position is:
€79 800,00 - €137 770,00
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 location’s 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.