Sr. Manager QA

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

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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 

J&J Innovative Medicine is recruiting for a Sr. Manager QA - Clinical Supply Chain reporting to QA-CSC Director - IMP Qualified Person and to be based in Beerse (Belgium).

Job summary

This function acts as a back-up QP, actively supporting the QP certification activities for investigational products (Small Molecules, Large Molecules and Advanced Therapies).

This role will support the Qualified Person to ensure compliance with applicable procedures and guidelines for all activities that are part of the Clinical Supply Chain world-wide (CSC). This can only be achieved by teaming up with partners in the CSC, with other quality functions and with multiple other functions that are collaborating in the development of a product, next to members of the own department.

This role will also help to prepare our CSQ team for the future, by analyzing key performance metrics and defining, implementing and tracking key strategic objectives, continuous improvements and standardization efforts.

Supports inspections and inspection readiness.

The key accountabilities also include coaching a team of direct reports.

This role also has the ability to represent J&J in different global fora such as ECA, EFPIA, EU CTR working group.

Qualifications

• QP Certification required (Belgian HA)
• Minimum 8 years experience in Pharmaceutical industry required.
• Strong team player and ability to collaborate and lead quality initiatives across multiple functions/organizations required.
• Strong project management skills preferred.
• Ability and experience to proactively identify and mitigate risk, significantly reducing any risk to regulatory submissions required.
• Ability to manage complexity
• People management experience
• Solution oriented thinking and experience analyzing information to make decisions required.
• Knowledge of root cause investigations required.
• Experience in operations and/or development activities with excellent scientific and/or technical insights required.
• Ability to drive proactive quality and bring quality solutions to issues at senior management level required.
• Strong communication skills and demonstrated great leadership skills in bridging or liaison roles required.
• Sound business acumen and ability to frame proposals as value propositions preferred.

Personal attitude and mindset

• Drive for innovation and change to ensure competitiveness
• Can-do mentality, agility, resiliency & flexibility to work with stretched goals and deadlines
• Set targets for a team and work towards these goals
• Understand cultural differences
• Communicate, motivate, negotiate and being an assertive person having impact
• Showing high sense of responsibility

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Language Requirements:  Fluency in English and Dutch languages

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