Johnson & Johnson - Quality Systems & Operations Manager

Johnson & Johnson is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day and have been for the last 130 years.
The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.

We are looking for a talented Senior Manager in Quality Systems & Operations for the EMEA region for our Business Quality group within the Medical Devices segment.

The job location can be in any EMEA site.

OVERALL PURPOSE OF JOB:

The Sr. Manager Quality Systems & Operations is responsible for ensuring a robust development, implementation, sustainability and continuous improvement of quality system processes.

He/She is a business enabler and ensures that the processes are lean, optimized and efficient across the region and that redundancies are minimized /eliminated.

He/She builds partnerships with the appropriate functions, identifies roles and responsibilities to ensure that the processes are effectively designed, deployed, communicated and trained throughout the EMEA region.

He/She provides leadership and coaching to the Business Quality SMEs. He/she leads the Project Governance Council, ensuring that projects are transparent and on track.

He/she calls out the risks accordingly and represents EMEA region in review boards, Councils and steering committees.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Building and leading a high performing team;

  • Providing technical expertise and mentorship to the team and overall organisations.

  • Ensuring that the processes such as the ones below are in place, documented and fit for purpose :

    • Labeling, Repack/Relabel

    • Purchasing Controls (Suppliers, Distributors, POLO management)

    • Service & Repair and Value Selling offerings (e.g.: Service and Technology related QMS processes)

  • He/she works with functional partners globally to ensure reliable data is available, well understood and used to continuously improve processes;

  • Serves as an SME, and coaches the organisation on applicable processes;

  • Provides leadership to ensure that day-to-day decisions are well-supported and documented. Monitors progress and effectiveness of those processes.

  • Supports audits, inspections and corrective actions design and implementation both on EMEA and Local Operating Company level.

  • Leads projects seeking to simplify processes across the organization, to reduce redundancies and further improve compliance in a changing healthcare environment.

  • Ensures that adequate communication of quality & compliance needs and status to all affected partners;

  • Requests data and metrics reports and files for management reports. Examines results from management reviews, third party inspections and internal audits and proposes and drive continues improvement.

Qualifications
Essential knowledge and skills:

  • University/Bachelor’s Degree or Equivalent

  • Requires 8-10 years related experience equivalent function

  • Local Operating Company operational experience / In country execution in the related processes (e.g.: Labeling, Repack/Relabel, Purchasing Controls, Service & Repair and data analytics)

  • Ability to translate complex information/ data into easy to understand concepts to support reliable decision-making at all different levels (from operational to senior leadership)

  • Excellent written and oral English communication (any other language is a plus)

  • Proven track record of leading a diverse and virtual team

  • Experience with hosting audits & inspections

  • Value Selling offerings such as hospital managed services, app /software as medical devices is a plus

  • EU MDR knowledge is a plus

  • Strong collaboration skills and ability to build partnerships at all levels of the organization

  • Strong mentoring skills

  • Strong analytical and reporting skills

  • Strong Project Management experience

  • Principles of Process Excellence & Lean

STRENGTHS YOU'LL NEED FOR THIS ROLE:

You are customer-centric; accountable; self-directive; strategic; excellence driven, strong communicator/ diplomat, out of the box thinking, creative.

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.