Sr Director, External Quality Large Molecules - Janssen Pharmaceuticals - Beerse
Johnson & Johnson Family of Companies
Région
Beerse
This position leads the Large Molecules (LM = LM API world-wide and FF EMEA/US) organization within External Quality (EQ).
This position directs and leads the Quality Assurance, Compliance and Quality Management oversight and activities for the LM External Manufacturers.
This position sets the strategic direction and provides leadership in the selection, development of external manufacturers and for reliability and pro-active quality programs with External Manufacturers.
This position provides leadership to and manages the LM EQ group.
This position works closely with the management of Partnership & External Supply (PES), Quality Assurance functions, Global Planning and Technical Operations, internal JSC sites and other stakeholders.
This position directs and leads the Quality Assurance, Compliance and Quality Management oversight and activities for the LM External Manufacturers.
This position sets the strategic direction and provides leadership in the selection, development of external manufacturers and for reliability and pro-active quality programs with External Manufacturers.
This position provides leadership to and manages the LM EQ group.
This position works closely with the management of Partnership & External Supply (PES), Quality Assurance functions, Global Planning and Technical Operations, internal JSC sites and other stakeholders.
RESPONSIBILITIES:
- Within EQ LM direct the Quality and Compliance activities related to reliability and proactive quality programs for External Manufacturers (based on risk management processes).
- Selection, qualification and monitoring of External Manufacturers
- Technology transfer and improvement of existing manufacturing processes
- Overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products
- Investigations, issue resolution, CAPA and change control
- Investigation of customer complaints
- Coach, train, lead and develop the EQ LM group to meet Quality, Compliance requirements and business expectations.
- Influence and build relationships with External Manufacturers and other internal parties to achieve objectives.
- Participation and representation of EQ as a whole and LM in particular in various ad hoc JSC, Pharmaceutical sector and J&J forums and councils.
- Follows up 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 global or regional management reviews and executive management reviews for monitoring of trends, identifying issues, recommending and implementing appropriate actions.
- Acting as senior level interface to key Health Authorities in the region for all of JSC External Manufacturing.
- Interfacing with the Product Management and Customer Management teams to supply the markets.
- Signs quality agreements with External Manufacturers.
- Can act as delegate for VP EQ in quality and compliance related matters, in case of absence when requested.
ESSENTIAL FUNCTIONS:
- Leadership: Provide leadership and ensures quality and compliance activities related to 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. Provide balanced leadership and management of quality and compliance risks with business needs. 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. Identify, lead or sponsor 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. Collaborate with site and global business functions to establish the vision and strategies for reliability and pro-active quality.
- Compliance: 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. Monitor adherence to metrics for Quality within and across business unit. ensures issues are escalated lo senior management where appropriate.
- Core Business: Ensured delivery on project timelines including New Product introduction projects, business continuity and compliance projects. Provides direction, oversight, and development of staff. Assures that an appropriate talent pool is developed, and succession planning in place to support current and future business needs.
- People Leadership: Effectively lead and develop direct reports.
- Provide Day-to-Day management of EQ Central Operations and Contractors
Qualifications
- Minimum Bachelor's Degree in (bio)chemical, Scientific or Technical discipline is required; Advanced degree (MS, MBA) is preferred;
- A minimum of 15 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; Experience in External Manufacturing, Quality Event Management and/or Quality System Development is preferred;
- Ability to develop Quality Systems and provide cGMP compliance support to External Manufacturers is required; In depth knowledge of global cGMP requirements and ISO requirements is required; Advanced knowledge and proven application of Process excellence tools is preferred.
- 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-functional, multi-site and/or international teams.
- Proven track record of successful business or process improvements.
- Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style required;
- 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.
- Travel: Ability to travel at 30 to 50% - both domestic and international is required.
- Position location: New Jersey, Pennsylvania, California and Georgia – US, Puerto Rico, Schaffhausen and Bern - Switzerland, Leiden - Netherlands, Cork – Ireland, Latina- Italy, Singapore and Shanghai. Other Janssen sites will be discussed case by case.
Primary Location
Belgium-Antwerp-Beerse-
Other Locations
Italy-Lazio-Latina, Netherlands-South Holland-Leiden, Singapore-Singapore-Singapore, Ireland-Cork-Cork, Switzerland, United States, China-Shanghai, United States-Puerto Rico
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality
Requisition ID
2005835774W