Sr. Director, Quality Control Laboratories - Medical Devices - J&J Family of Companies (Puerto Rico)
Johnson & Johnson is currently recruiting the Senior Director, Global Quality Control Laboratories for our Medical Devices (MD) segment. Our Medical Devices companies, comprised of Ethicon, CSS (Cardiovascular & Specialty Solutions), and DePuy Synthes have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
This global leader oversees Quality Control Laboratories for Medical Device Supply Chain and will support manufacturing and the timely delivery of products to customers. This position reports into the Vice President MAKE Quality and defines and drives implementation of global strategies for complex programs and teams. S/he will identify, develop and implement innovative solutions for complex and broad-based scientific/ technical issues that have high impact across global business units. Provides oversight to the Regional Laboratory Leaders and the Global Laboratory Capability Centers (GLCCs) and will act as an expert (both internally and externally) on scientific and business objectives across Q&C and industry.
Responsibilities:
+ Oversees 5-10 direct reports and operates through globally based associates under a home office management structure.
+ Chairs the Global Quality Control Laboratory Leadership Team providing global leadership and direction for MD Q&C Laboratories.
+ Partners with the MD Q&C, R&D, Make, BQ and other key stakeholders to develop and maintain processes ensuring continuous, high quality and reliable supply of products to the market.
+ Influences senior leaders and external colleagues/ partners across disciplines in driving and aligning strategic and operational activities between business units/ functions.
+ Strategic development and successful execution of Laboratory quality strategies for existing product portfolios as well as for new product launches. Is accountable for implementation, deployment & support of One Medical Device Q&C Laboratory strategic initiatives for testing groups and GLCC global functions.
+ Defines and implements global standardized framework of QC policies and standards that will lead to world class performance in terms of quality, compliance, innovation and efficiencies.
+ Governs global capabilities development (i.e. people, process, technology) and manages potential for synergies and capacity optimization to support global quality control laboratories.
+ Uses knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency.
+ Ensures Quality System readiness and works with Compliance team to ensure state of inspection readiness and compliance for the laboratories.
+ Develops and manages budget, organizational structure and business requirements / metrics to accommodate business needs
+ Communicates business related issues or opportunities to next management level. Manages escalation from Regional Hub and GLCC leads and interacts with key stakeholders to resolve issues and increase One MD QC Laboratories visibility within MD team.
+ Drives transformation, both internally and externally, through process design decisions to accomplish targeted business outcomes. Internal and external partnerships include:
+ Medical Devices: QA, MAKE, Supply chain, HR, Finance, IT, R&D, Global / Johnson & Johnson Supply Chain Quality
+ Enterprise segment quality organizations and external regulatory agencies and commissions
+ Applies in depth knowledge of supply chain optimization techniques in reviewing internal and external tools and systems and recommending solutions for optimization.
+ Manages a globally-dispersed diverse staff and related stakeholders in quality activities to optimize favorable outcomes and ensure balanced decision-making. Fosters organizational development.
+ Creates and drives a high level of commitment to customer service.
+ Ensures subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, accordingly.
+ Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
+ Engages in proactive relationships with management of Global regulatory agencies, as required for this function, and builds and sustains outstanding associations with them.
+ Analyzes regulatory authority’s programs and activities in areas relevant to medical device products and advises management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
+ 25-30% travel with global reach.
+ Primary location can be J&J site in North America, LATAM or Europe.
Qualifications
+ University/Bachelor’s degree, required. Life Sciences field of study, preferred.
+ 10-12 years relevant experience in laboratory management or equivalent supply chain experience is required. Senior level experience in medical devices or life science management, quality management or related field (Medical Devices, Pharma, Biotechnology, or equivalent) is preferred.
+ Proven track record in organizational excellence, managing high performing organizations within a global matrixed environment.
+ Proven experience building good rapport with internal & external stakeholders (including regulatory and external business partners).
+ Strong interpersonal partnering capabilities with a focus on customer service and delivering results is required. (Ability to build and nurture strong and positive relationships with Therapeutic Areas, Commercial and R&D leadership).
+ Solid knowledge of international regulatory requirements and agencies. In-depth understanding of medical devices processes and manufacturing, and GMP requirements.
+ Demonstrated knowledge of GxP regulations and proven cycle of success in implementing and maintaining GMP compliance.
+ Strong background in quality systems management (risk management, control strategy, product quality management, etc).
+ Sound business skills, including financial acumen and business planning with previous experience with budget and capacity planning (i.e., OPEX, CAPEX, headcount).
+ Ability to translate strategy to execution and drive organization forward in executing and delivering results.
+ Ability to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.
+ Excellent written and verbal communication skills with an open, collaborative, interactive leadership style is required. Fluent verbal and written English communication skills. Other language skills, a plus.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
COMPANY DISCLAIMER
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Primary Location
United States-New Jersey-Somerville-
Other Locations
Europe/Middle East/Africa-Switzerland-Neuchâtel, Europe/Middle East/Africa-Israel-Northern-Kiryat Shmona, United States-Texas-San Angelo, United States-Texas-Irving, Asia Pacific-India-Bihar-Aurangabad, United States-Georgia-Cornelia, Europe/Middle East/Africa-Germany-Schleswig Holstein-Norderstedt, United States-Puerto Rico-San Lorenzo, North America-United States-Georgia-Athens, United Kingdom-England-Blackpool, Latin America-Mexico-Chihuahua-Juarez, Asia Pacific-China-Anhui-Suzhou, Asia Pacific-China-Sichuan-Mianyang, Asia Pacific-China-Guangdong-Guangzhou (Canton), Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf, Europe/Middle East/Africa-Israel, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Latin America-Brazil-Alagoas-São José da Laje
Organization
Ethicon Inc. (6045)
Job Function
Quality Control
Requisition ID
00001E40