Director, Supplier Quality Category API/Biologics

Johnson & Johnson is recruiting for a Director, Supplier Quality Category API/Biologics. This position can be located in Bridgewater, NJ; New Brunswick, NJ; Raritan, NJ; Malvern, PA; Beerse, Belgium; or Geel, Belgium.


Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. 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.


With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.


The Director, Supplier Quality Category API/Biologics, leads the Category of API/Biologics across the Johnson & Johnson Enterprise (Janssen, Medical Devices and Consumer), ensuring the appropriate Quality Leadership is available at all times and skills and competencies are consistent with present and future needs. The Director will work close with his/her sourcing partner to build reliable supply base aligned with the Enterprise Strategy to support a supplier spend of ~$800 million and annual Financial revenues of ~$25 billion.  This includes the support of ~250 unique materials, ~300 suppliers and serving 22 internal sites.  The Director, Supplier Quality Category API/Biologics will build a comprehensive understanding of the business needs, supplier landscape and supplier innovation capabilities. This position, in conjunction with sourcing partners, is accountable for the overall performance of the suppliers on this category, considering long and short term strategy. This position will also drive Quality System efficient execution and reduce risk of non-conforming product.


The Director, Supplier Quality Category API/Biologics will:

  • Work with Enterprise SQ Category Governance team, aligning strategy, processes and priorities with all SQ Category teams (e.g. Plastics, Metal, etc.).
  • Act as subject matter expert (SME) for Enterprise Supplier Quality as it pertains to API/Biologics suppliers.
  • Work with sourcing partners to develop the strategy for multiple key APIs/Biologics, aligned to the global category strategy.
  • Work close with sourcing partners to monitor at the API/Biologics suppliers to ensure activities comply with industry, company and regulatory expectations for safety, technical rigor and cGMP practices.
  • Support multiple supplier selection and supplier qualification projects for API/Biologics, engaging with multidisciplinary teams as well as key stakeholders.
  • Create network of API/Biologics supplier quality experts across Enterprise.
  • Lead, develop and implement across Enterprise standardized best practices for API/Biologics suppliers in the areas of (but not limited to) component qualification and validation, process control, quality agreements and CTQ Cascade, aligning with Enterprise Standards. 
  • Work closely with Enterprise API/Biologics Category Leaders (Sourcing) to provide input to long term strategy from a supplier quality perspective and participate in strategic supplier business reviews.
  • Align with the businesses and execute sourcing strategies for the specific technology area (API/Biologics).
  • Shape the supply base & supplier responsiveness, sustainability and reliability improvements.
  • Ensure supply issue escalation and resolution processes.
  • Ensure deployment of Enterprise Methodologies for Risk Reduction, Partner Development, and Supplier Enable Innovation.
  • Ability to share knowledge and influence colleagues in other disciplines at senior levels of the organization and be able to work across Enterprise.
  • Participate in API/Biologics supplier assessments, as needed, and aid in close out of improvements with common solutions where appropriate utilizing Lean and Six Sigma methodologies.
  • Collaborate and partner with stakeholders across multiple functions (e.g., Sourcing, External Operations, R&D, Partner Development and Engineering), operating companies, and Senior Leadership across Enterprise to identify and address common needs and opportunities.
  • Assess different elements of supplier quality data relative to the category (e.g. quality systems audits, supplier assessments, internal audits, complaints, field actions, external audits at Metals supplier, etc.), identify areas of improvement and create initiatives to implement them.
  • Partner with the respective management for their sphere of influence to develop and support initiatives and responses to quality risks and threats.
  • Ability to execute complex, multidisciplinary technical projects and understands the interrelationship among quality functions and with other business functions.
  • Ability to influence business and strategic directions.

  • A minimum of a Bachelor’s degree is required with a focus in Engineering, Business, Finance, Supply Chain or QRC disciplines or equivalent is preferred.
  • A minimum of 10 years of business experience is required; Experience in QRC, R&D, or Supply Chain, including active pharmaceutical ingredient (API) manufacturing is preferred.
  • A minimum of 5 years of project/program management, strategy development or related experience is required.
  • Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of the processes and functions involved in API development and commercial manufacturing is required.
  • Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector is required.
  • Strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence is preferred.
  • Ability to lead, shape and drive a diverse, multicultural and virtual team is required.
  • Ability to develop strategic direction and track record of strategy implementation is required.
  • Demonstrated ability to work remotely and partner globally is required.
  • Ability to lead, negotiate and influence others in a complex matrix organization is required.
  • Ability to communicate clearly and concisely across all levels of the company and across the global MD&D supply chain is required.
  • Ability to foster an effective multi-functional, cross region, cross company team environment is required. 
  • Outstanding presence and communication skills, including the ability to inspire trust and quickly build credibility is required.
  • Strategic thinking ability complemented by hands-on operational and business planning orientation is required.
  • Strong business acumen is required.
  • This position will be based in Bridgewater, NJ; New Brunswick, NJ; Raritan, NJ; Malvern, PA; Beerse, Belgium; or Geel, Belgium and up to 50% domestic & international travel is required.

Primary Location
United States-New Jersey-New Brunswick
Other Locations
North America-United States-New Jersey-Bridgewater, Europe/Middle East/Africa-Belgium-Antwerp-Geel, North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Johnson & Johnson Services Inc. (6090)
Job Function
Quality (Generalist)

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