J&J Family of Companies Sr Director, ESIQ Supplier Quality in Beerse, Belgium

‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.

This position leads the Supplier Quality organisation within ESIQ. This position directs and leads the Quality Assurance, Compliance and Management oversight and activities for Suppliers and External Manufacturers (more specifically Suppliers and External Manufacturers of API, Excipient, Packaging Material & Devices, Components and BIO materials used within Janssen and Janssen Diagnostics).

The senior director sets the strategic direction for reliability and pro-active quality programs with Suppliers and External Manufacturers.

He/she also sets the strategic direction for the overall development, implementation and execution of quality systems in support of Supplier Quality Management. Provides leadership and manages the SQ group leaders and SQ Operations lead and works closely with the management of Procurement, Quality Assurance functions, internal JSC sites and other stakeholders.

Essential Functions:

  • Within ESIQ/SQ direct the Quality and Compliance activities related to reliability and pro-active quality programs for suppliers and External Manufacturers (based on risk management processes ).

  • Coach, train, lead and develop the Supplier quality group to meet Quality, Compliance requirements and business expectations.

  • Influence and build relationships with suppliers and External Manufacturers and other internal parties to achieve objectives.

  • Participation and representation of ESIQ-SQ in various JSC, Pharmaceutical sector and J&J forums and councils.

  • Reports on performance and issues via metrics and reports, including collecting data, analyzing trends, and preparing reports as required.

  • Escalating issues as appropriate to Senior Management and supporting the Executive Management Reviews.

  • Assessing current quality systems and recommending improvements in order to enhance quality, to promote continuous improvement and to promote pro-active quality culture.

  • Participates in regional management reviews and executive management reviews for monitoring of trends, identifying issues, recommending and implementing appropriate actions.

  • Frequent interaction with Management of Procurement, Quality Assurance functions, internal JSC sites and other stakeholders.

  • Signs quality agreements with suppliers and External Manufacturers.

  • Act as delegate for VP ESIQ in quality and compliance related matters, in case of absence of VP ESIQ or as requested

Qualifications

Required:

  • A minimum of 12 years experience in Pharmaceutical OR Medical Device OR Biotech or highly regulated environment is required;

  • Experience in drugs, biologics or medical devices quality assurance or manufacturing is required;

  • Ability to develop Quality Systems and provide cGMP compliance support to Suppliers and External Manufacturers is required;

  • Seasoned leader with direct people and organizational leadership/project management experience is required; A minimum of 8 years people management experience is required; Strong team collaboration mentoring and coaching skills are required; experience in leading cross-fucntional, multi-site and/or international teams.

  • Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style required;

  • Ability to travel a minimum of 50% both domestic and international is required.

  • Proven track record of successful business or process improvements.

  • Refined skills in the following Global Leadership areas required: Integrity and Credo-based Actions; Strategic Thinking; Big Picture Orientation with Attention to Detail; Intellectual Curiosity; Collaboration and Teaming; Sense of Urgency; Prudent Risk-taking; Self-awareness and Adaptability; Diversity and Cross cultural inclusion experience; Results and

  • Performance Driven.

Preferred:

  • Minimum Bachelor's Degree in Chemical, Scientific or Technical discipline is required; Advanced degree (MS, MBA) is preferred;

  • Experience in External Manufacturing, Quality Event Management and/or Quality System Development is preferred;

  • In depth knowledge of global cGMP requirements and ISO requirements is required; Advanced knowledge and proven application of Process excellence tools is preferred.

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset. We take your career seriously.

As part of a global team in an innovative environment your development is key and our day-to-day responsibility.

Through e-university, on the job training, various projects and programs, we ensure your personal growth.

Our benefits make sure we care for you and your family now and in the future.

Primary Location

Belgium-Antwerp-Beerse

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Quality (Generalist)

Requisition ID

1700186619W