Director EMEA Quality Systems

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/.

Ethicon is recruiting for a Director, EMEA Quality Systems, located in Zug, Switzerland.
Lead the Ethicon Quality Systems processes and organization by:


* Ensuring the Ethicon processes in EMEA are effectively maintained achieving a state of compliance across all Ethicon sites.


* Providing management with timely and comprehensive quality data that supports analysis, and product and process improvement decisions.

Key Responsibilities:


* Leads the business execution of EMEA Quality Systems processes in Ethicon including (but not limited to): Procedure Packs, Appointment of Management Representatives, Legal Manufacturer & Legal Entity Structure, Training, Certificate Management & Change Notifications and Authorized Representative Oversight.


* Drive operational excellence of EMEA Quality Systems under applicable J&J procedures and regulatory requirements.


* Lead Ethicon teams responsible for integration of Quality Systems and creation of new Legal Manufacturers & Legal Entities.


* Lead large Quality System deployment projects for EMEA & APAC Ethicon sites, ensures readiness and leads issue identification & improvement efforts post-deployment.


* Partner with NA & LATAM Quality Systems Lead to ensure consistency in execution and deployment of Quality management system.

Education:


* BA/BS degree or equivalent is required

Experience and Skills:

Required:


* Eight (8)- Ten (10) years of experience in the Pharmaceutical, Medical Device or Biologics industry with managerial experience required; or an equivalent combination of education and experience

Preferred:


* Experience owning & driving Quality system processes strongly preferred


* Shown experience in successfully collaborating across functions and delivering business results


* Strong documentation skills and technical writing capability.


* Experience in supporting health authority and or Notified Body inspections.


* In-depth knowledge of EU MDR, Legal Manufacturer and Legal Entity structure and requirements.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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