Director External Quality Small Molecule Product Development

工作内容

Position Summary

This position provides Quality Assurance, Compliance and Management oversight for multiple External Manufacturers worldwide that are involved in development activities and production of clinical batches for all small molecules (API/DP).

It provides strategic direction and leadership in the selection, development, and management of External Manufacturers in the different regions and contributes to the overall development, implementation, and execution of quality systems in support of the material sourcing and manufacturing.

This position provides leadership and management to a group of professionals located in different regions across the globe that have quality oversight of supply chain activities and execution of quality systems that support the production and packaging of all externally produced small molecule products.

Major Duties & Responsibilities

Leadership

• Provides leadership and ensures quality and compliance activities related to clinical External Manufacturers. This includes the deployment of reliability and pro-active quality culture programs, with an emphasis on continuous improvement, global alignment, and customer satisfaction.
• Steers and organizes quality activities with External Manufacturers including quality agreements, deviations, investigations, change control, product transfers, risk assessments and recalls
• Directs all the Quality and Compliance activities related to clinical External Manufacturers in all regions to assure flawless qualification and to assure compliant supply for clinical batches.
• Manages, trains, coaches, and develops the quality professionals.
• Provides direction, oversight, and development of staff.
• Develops and fosters an environment of innovative thinking and learning, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress. Identifies, leads, or sponsors cross-functional projects that impact External Manufacturing Management, and removes barriers to support and ensure success.Strategy:
• Works with business partners and across the regions and enterprise to ensure alignment of External Manufacturing management activities with strategic business direction.
• Creates and implements strategic direction based on NPI, R&D and new business synergies.
• Collaborates with site and global business functions to establish the vision and strategies for reliability and pro-active quality on new and existing external manufacturersCompliance:
• Ensures that the quality process and systems to support suppliers are adhered to and maintained.
• Communicates expertise and guidance on relevant regulations, directives on standards and industry guidance related to quality system design and operation.
• Monitors adherence to metrics for Quality within and across business units.
• Ensures issues are escalated to senior management where appropriate.
• Participates in due diligence audits and supports due diligence and business development in their scope.
  

Core Business

• Ensures delivery on project timelines including New Product introduction projects, business continuity and compliance projects.
• Provides balanced leadership and management of quality and compliance risks with business needs.
• Influences and builds relationships with External Manufacturers and other internal parties to achieve objectives
• Participates and represents EQ in various DPDS, JSC, Pharmaceutical Sector and J&J regional forums and councils
• Assures that an appropriate talent pool is developed, and succession planning is in place to support current and future business needs
  

Other

Acts as delegate for the Sr Dir EQ in various quality and compliance related matters, in case of absence and when requested.

Internal

Key Working Relationships:

Has frequent interaction with Product Development Operations, other Quality Assurance functions, internal management and Commercial Supply Chain sites, technical integrators and other stakeholders to optimize the overall clinical supply chain

External

Influences and builds relationships with External Manufacturers and other internal parties to achieve objectives

Education

Qualifications

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

Related Experience

• 10 years of experience in Pharmaceutical, Medical Device, Biotech or highly regulated environment
• Experience in quality assurance, validation/qualification or manufacturing is required
• Experience in External Manufacturing, Quality Event Management and/or Quality System Development is preferred.
  

Knowledge, Skills and abilities:

• Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers
• In depth knowledge of global cGMP requirements
• Seasoned leader with direct people and organizational leadership experience.
• Strong team collaboration, mentoring and coaching skills
• Experience in leading cross-functional, multi-site and/or international teams.
• Interpersonal skills to build and nurture long term relationships, influence up and down, negotiate acceptable outcomes, multiple disciplinary, cross-cultural environments in External Manufacturers and J&J.
• 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.
• Proficient in written and spoken English
  

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

Europe/Middle East/Africa

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Quality

Requisition ID

2206061154W