Mgr Quality Assurance Device assembly and packaging

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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.

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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.