Director, Quality and Reliability Job

Job description

Director, Quality and Reliability-000011Q0DescriptionJanssen Supply Group, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Quality and Reliability. The position will be based at a global Janssen Supply Chain site in Raritan, NJ; Horsham, PA; Latina, Italy; Cork, Ireland; Schaffhausen, Switzerland; Leiden, The Netherlands; Beerse or Geel, Belgium.
Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.
JanssenPharmaceuticalsInc.com for more information.
The Director, Quality and Reliability will drive proactive Quality and Compliance through driving key prevention strategic initiatives in support of the Quality Strategy. Provide leadership and own key JSC Quality processes and such as Quality Management Review, Training System (curricula design and training efficacy), Execution Systems Support and Data Governance/Data Integrity. Provide direction and leadership for the BtB governance program. J&J PMO role for FDA Quality Metrics implementation and Member of Quality Culture metric development.
This position will be planning and directing resources and activities of the Quality and Reliability functions related to Management Review, Training, Execution Systems and Data Governance/Data Integrity and overall responsibility for the direction, coordination, and evaluation of these functional areas. Accountability to provide oversight for preparing data for and conducting Management Review, and provides oversight and assurance to data trending, quality system metrics identification and analysis. Providing oversight and guidance for the JSC Training Program as it relates to Combination Products.
Provides global leadership, direction and development to all direct reports, ensuring performance is reviewed on a frequent basis. Leads teams and ensures that the daily operations are in alignment with business needs. Provides guidance to functional organizations and project teams across the globe, and collaborates with local and global cross-functional groups to develop and deliver process improvements.
Provides strategic support and direction to the Execution Systems COE. This includes supporting critical projects and the BtB program.
Provide strategic and tactical oversight for the training program with in JSC. Ensure metrics are proactive and training is efficient and effective across the JSC sites. This role will require the ability to communicate across all levels of the organization; strong organizational, conflict management and decision-making skills; and the ability to translate strategy to execution and drive the organization forward in executing and delivering results. The role will require in-depth understanding of FDA CFR part 3, 4, 210, 211, and 820; Also ICH, ISO 13485, and industry technical standards relative to Combination Product development.
QualificationsA minimum of a Bachelor’s Degree in Chemistry, Biology, Engineering, or other scientific discipline is required; an advanced degree is preferred. A minimum of 7 years of related experience in medical device, pharmaceutical or biopharmaceutical industry is required. Deep understanding of product and process development process and associated regulatory and quality requirements is required. Knowledge of the business environment inside a quality organization across various roles (e.g., quality operations, Quality Systems, pre-production quality assurance, validation, market quality, regulatory, etc.) is required. Experience supporting and working in a matrix organization is preferred. Demonstrated strategic thinking capabilities and the ability to define a future vision is required. Demonstrated people leadership and management skills is required. Financial savvy, versed in operational and project budgeting (OPEX, CAPEX and headcount) is preferred. Experience in Process Excellence (eg. Design Excellence, Six Sigma, etc.) tools and methodology is preferred. Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment is required. Excellent technical writing skills with the ability to draft, align, and drive structured technical writing such as SOPs, protocols, and reports is required. Broad knowledge of software platforms for use in the pharmaceutical industry (e.g Empower, Trackwise, Compliance wire) is required.
This position will be located at a global Janssen Supply Chain site in Raritan, NJ; Horsham, PA; Latina, Italy; Cork, Ireland; Schaffhausen, Switzerland; Leiden, The Netherlands; Beerse or Geel, Belgium, and will require approximately 25% of travel.
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J2W:LI NAPrimary Location:North America-United States-New Jersey-RaritanOther Locations:Europe/Middle East/Africa-Belgium-Antwerp-Geel, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: JANSSEN SUPPLY GROUP, LLC (6046)Job Function: Quality AssuranceCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and 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. EEO is the Law EEO is the Law GINA Supplement