Ethicon Global Biologics is currently recruiting for a Director – WW Supplier Quality Management. The position can be located in Irvine, CA; Switzerland, Austria, Germany, Italy, Czech Republic, Germany or Israel.
Global Biologics is currently comprised primarily of the Ethicon Biosurgery Business Unit and is a unique business that includes medical devices, biologics and combination device/biologic products. It is comprised of the Omrix business in Israel, the newly acquired BioSeal business in China, the JJWM legacy businesses as well as several strategic external partnerships.
Reporting to the Vice President Global Biologics Quality, the Director – WW Supplier Quality Management will:
· Provide Worldwide Supplier Quality Management leadership in the development, implementation and continuous improvement of the WW Biologics Supplier Quality Management Systems.
· The candidate will also establish, maintain and continually improve a robust Supplier Quality Management System in support of the Global Biologics business strategy and objectives.
· S/he will also provide leadership on the standardization of best practices in Supplier Quality Management Systems across Global Biologics and to provide ongoing analysis and reporting on the effectiveness of the Worldwide Supplier Quality Management System to the Global Supply Chain and Worldwide Management Boards.
· The candidate will interact and collaborate with the following teams on a regular basis: Global Biologics Quality Leadership Team, Quality Operations Leadership Team, Global Surgery Group Supply Chain Leadership Team, Ethicon Biosurgery Management Board, Corporate QCS personnel, External Regulatory Body personnel as required and External Sub-Contract Management as required.
The candidate will:
· Establish, manage, maintain and continuously improve all Quality activities associated supply and contract services including raw materials, components, packaging materials, manufacturing/packaging locations, manufacturing support services, product distribution providers, licensing partners, testing laboratories, affiliate locations and/or acquisitions.
· Will also establish a Quality strategy and supplier relationship to ensure compliance for all Global Biologics suppliers (internal and external) and contract manufacturing/packaging and testing support services.
· Will manage the strategy and relationship to ensure that compliant systems and procedures are in place from development and throughout the commercialization life cycle.
· Administer regulatory requirements and Global Biologics/J&J policy and standards to ensure the proper balance of business and compliance needs.
· Manage this balance to optimize continuous growth at the supplier and contractor locations. Directs and provides GMP assessments for potential new suppliers, contract manufacturers, sub-contractors and licensing and acquisition candidates.
· Develops policies and requirements for Supplier Quality Management Systems in order to minimize compliance and product quality risk while increasing business portfolio.
· Writes, negotiates and ensures execution of Supplier Quality Agreements.
· Facilitates the resolution of Supplier Quality issues as required.
· Develop and manage SQM budget.
· Establish, maintain, analyze, report and continuously improve the Supplier Quality Performance Measurement system.
· Provide trend analysis for future outsourcing business strategy.
· Will identify opportunities to continually improve quality, cost and time factors, consistent with the Global Biologics business objectives.
· Establish and report appropriate Worldwide Supplier Quality business measurements, analyze these measurements and identify the most significant issues and prioritize for action.
· Lead, sell and implement improvement opportunities and problem solutions.
· Provide regulatory interpretation, consulting, training and assessment to ensure company Supplier Quality Management systems are aligned with current regulatory requirements, company standards and industry trends.
· Represent Global Biologics on relevant company, corporate or industry projects team or committees as required in conjunction with Worldwide Quality Management formulate Worldwide Quality strategy and requirements for Global Biologics.
· Serves as technical expert for all Global Biologic Supplier Quality Management functions.
· Lead the establishment and implementation of key worldwide Standardized Operating Procedures and Practices and ensure cross-functional synergies across all Global Biologic facilities in the area of Supplier Quality Management.
· Represent Supplier Quality during Regulatory Inspections.
· Other duties and responsibilities as assigned.
· A Master’s Degree in Quality Management, Engineering or related field is required.
· A minimum of 10 years’ experience in a medical device, pharmaceutical or similar regulated industry is required with a minimum of 3 of those years in a Quality Leadership role.
· Previous people management experience is required.
· Experience managing multiple leveled employees in a global capacity is preferred.
· Must have a demonstrated ability to effectively develop and negotiate Supplier Quality Agreements to ensure compliance with regulatory requirements and business needs.
· The candidate must have broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, Pre production Quality as well as good working knowledge of related functions such as operations, supplier management and product development.
· Experience in auditing to both FDA QSR and ISO 9000 standards is required.
· Previous experience managing multiple projects is a required.
· Demonstrated knowledge of business impact of compliance issues and risk management is required.
· Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required.
· Expert knowledge of Good Manufacturing Practices, regulations and validation methods is required.
· Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required.
· Experience of developing concise and audience-focused communications, both written and for presentations is required.
· Excellent communication and interpersonal skills are required.
· Ability to represent J&J in a leadership capacity at a variety of external forums is required.
This position can be located either in Somerville, NJ; Irvine, CA; Austria, Switzerland, Germany, Italy, Czech Republic, or Israel.
This position may require some travel both international and domestic.