Sr Director, External Quality - Small Molecules - Janssen Pharmaceuticals - Beerse
Johnson & Johnson Family of Companies
Région
Beerse
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
This position leads the Small Molecule (SM = SM API world-wide and FF EMEA/US) organization within EQ.
This position directs and leads the Quality Assurance, Compliance and Quality Management oversight and activities for the SM 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 SM 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 SM direct the Quality and Compliance activities related to reliability and pro-active quality programs for External Manufacturers (based on risk management processes). Providing strategic direction and oversight during:
- 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 SM 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 SM 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 Mgt 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.
- 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.
- 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 to 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.
Qualifications
Minimum Bachelor's Degree in 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.
Demonstrated understanding of regulatory requirements that impact Quality Systems specifically, and JSC more broadly;
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 a minimum of 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
Switzerland, United States, United States-Puerto Rico, China-Shanghai-Shanghai, Italy-Lazio-Latina, Netherlands-South Holland-Leiden, Singapore-Singapore-Singapore, Ireland-Cork-Cork
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality
Requisition ID
2005833735W