Director, External Quality

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, External Quality - Small Molecules - End to End Strategic Partnerships & New Modalities located in the Unites States, Puerto Rico or Europe. Preferably East Coast US location
- ideally NJ or PA; Beerse, Belgium; Dublin, Ireland; Cork, Ireland; Latina, Italy; Leiden, Netherlands; Basel, Switzerland.

The Director, External Quality - Small Molecules - End to End Strategic Partnerships & New Modalities leads the quality oversight of strategic projects that are spanning Drug Substance and Drug Product and, where applicable, Devices, with strong focus on the End to End (E2E) aspects of the brand or project.

The role is responsible for establishing and managing commercial E2E Quality of multiple Small Molecule products (Drug Substance and Drug Product) mainly from licensing alliances and acquisitions, and leadership of others doing the same. Role leads the quality aspects of these alliances/External Manufacturers (EMs) to ensure that products are available to meet customer needs, provide the highest quality and achieve maximum relationship value through accelerated innovation, supplier integration, process improvement, and collaboration. The position is involved in early engagement in Business Development and Alliance Management

The role has a broad understanding of external landscape within the Small Molecule Drug Product and Drug Substance scope and is responsible for closely aligning with EQ DPDS and other applicable teams to drive new product launches to commercial.
This position will provide Quality Assurance, Compliance and Technical Support for External Manufacturers (EMs) as applicable. Providing leadership in the selection, development and management of External Manufacturers under its scope. Providing QA support for technology transfer and improvement of existing manufacturing processes.
This position will partner with EM in defining Quality Strategy and Supplier Development Plan through internal benchmarking and knowledge sharing (e.g., JJOS, SQE2, etc.). Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence (e.g., PEx, Lean etc.).

This position will be responsible for developing functional strategic plan and ensuring alignment to Global EQ and JSC strategic plans. This position will lead work team to deliver business and quality goals with agility and patient focus, fostering innovative thinking and balanced management of quality/compliance risks with business needs. Work closely with Business Partners: Partnerships & External Supply (PES), Business Quality (BQ), Local Operating Countries (LOCs), etc. and other supply chain and enterprise functions to identify new opportunities, efficiencies or solve problems to meet business needs.
- Direct all of the Quality and Compliance activities related to External Manufacturing (EM) in the assigned work team and provide the proper interface to business partners (PES, Quality Assurance functions, technical owners and other stakeholders).
- Escalate issues as appropriate to Senior Management and support the Executive Management Reviews.
- Act as senior level interface to key Health Authorities for External Manufacturers.
- Interface with the Product Management and Customer Management teams to supply the markets.
- Assess current quality systems and recommend improvements to enhance quality and reduce cycle time
- Monitor trends, identify risk, recommend and implement appropriate mitigation actions.
- Provide cGMP compliance support to External Manufacturers by investigating and resolving quality issues.
- Ensure effective and compliant execution of quality system processes including nonconformance, CAPAs and change controls
- Investigate customer product quality complaints and adverse trend.
- Provide Quality oversight on technical transfer teams.
- Manage Health Authority Inspections of EM, monitor EM response and implementation
- Travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight
- Act as delegate for Sr Director EQ in quality and compliance related matters, in case of absence and when requested

**Qualifications**
- Minimum Bachelor's Degree required. Chemical, Scientific or Technical discipline is preferred; Advanced degree (MS, MBA) is preferred.
- 'A minimum of 10 years’ experience in Pharmaceutical, Medical Device, Biotech and/or highly regulated environment is required.
- Experience in pharmaceutical drugs, biologics and/or medical devices quality assurance and/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.
- Strong knowledge of global cGMP requirements is required.
- Experienced people leader (direct reports) is require