The overall Purpose of the Sr. Director of Business Quality for the NA Region is to ensure high quality products and services are available in the US and Canada each and every day, and to enable growth in the commercial business. This position oversees Quality and Regulatory Compliance for LOCs in North America This position oversees Business Quality for LOCs in North America. The Regional Head of Business Quality serves as the single point of contact with commercial for all quality and compliance-related issues and matters.
This position serves as a leader of the NA Regional Business Quality Leadership Team. This position reports directly to the Global VP of Business Quality at Janssen with a dotted line to the Company Group Chair Americas or one of the Presidents of the US LOCs covering all NA LOCs for Q&C. In cooperation with the members of that team, the incumbent is responsible for developing/deploying the Quality strategic plan and assuring the integration/alignment of the commercial quality strategy into the overall strategy of the NA Regional Commercial leadership teams.
This positions calls for a seasoned executive leader with significant people & organizational leadership experience (10+ years). Team collaboration skills and coaching skills. Excellent written and verbal communication skills, with an open, collaborative, interactive leadership style. Demonstrated strategic thinking capabilities, ability to help define a vision for the future. Ability to translate strategy to execution and drive the organization forward in executing and delivering results. Results-driven leader who commits to stretch goals and delivers results. Sound business skills, including financial acumen and business planning. Balanced decision-maker. Ability to build and nurture strong, positive relationships with business leadership and partners in IT, Manufacturing, Regulatory Affairs, Commercial and Quality functional groups. External relationships and visibility within Enterprise J&J, as well as networking external to J&J. Demonstrated understanding of regulatory requirements that impact Market Quality specifically, and JnJ more broadly. In-depth experience in dealing with regulatory inspections and inspectional requirements.
Quality Strategy And Resourcing
Develop regional Quality strategy to support the commercial organization. Integrate quality goals into commercial business goals; integrate business goals into quality goals. Be an end-to-end strategic partner for enabling and growing the commercial business. Anticipate the impact of emerging regional/local regulations and take proactive steps to anticipate potential issues & develop strategies to mitigate risk. Implement process changes as required in conjunction with impacted/responsible business partners. Influence Regulators and engage with industry and professional organizations to shape emerging regulations and support launch of new technologies in collaboration with ERO, SCQA, BRQ&C and RA. Develop the business case and approval for resources and funding needed by the business quality organization locally and regionally to execute Q&C goals and mitigate regulatory compliance risks in the NA Region.
Risk Management
Advocate for our patients/consumers; ensuring appropriate, comprehensive, risk- based quality decisions are made through the Quality Review Board Process to assure product in commercial distribution in each country in which we do business is safe, of high quality and fully compliant with local health authority requirements. Ensure robust compliance with J&J Standards and Janssen SOPs on the QRB process and Field Actions.
Ensure positive patient/end user experience; partner with Marketing, Medical Affairs, and other key business partners to implement promotional materials/training/patient support programs for our products to minimize AEs, PQCs and Device Malfunctions.
Ensure risk to patient and product availability are integrated into the quality decision-making process.
Connect with BRQC, JJRC, SCQA and other key business partners to communicate emerging product quality/safety/regulatory compliance issues to Management with Executive Responsibility.
Ensure a business-focused Quality Management Review is conducted at multiple levels to include: the Local Operating Companies and Regional Management of the Local Operating Companies which: Highlights risks and trends to product safety , product quality, product availability and regulatory compliance with global health authority requirements and J&J Policies; Drives corrective and preventative actions to address existing product safety risks, quality risks, and regulatory compliance gaps and monitors timely closure and effectiveness; Drives the development of strategies to minimize or prevent adverse events and consumer complaints.
Enabling Business Growth
Enable product launch into local markets; communicate quality and regulatory compliance risks to product launch to Commercial Business Partners. Develop regional quality capabilities to support commercial go-to-market strategies. Support new and existing go to market strategies, ensuring Commercial Suppliers, Distributors and Partners meet J&J and local Health Authority requirements. Partner with R&D, BRQC, PQM, RA and other business partners to ensure local patient/end user needs are incorporated in the Design to Value and New Product Design processes. Integrate data from post market surveillance into the design of product, promotional materials, end user training and support programs to improve patient/end user experience.
Quality Management System
Implementing a Quality Management System that is aligned Globally and Cross-Sector; integrating existing and new regulations to enable a favorable compliance profile with global health authorities. Lead and manage changes to the QMS with internal and external stakeholders regionally. Ensure the QMS executed in each LOC is aligned to the global QMS and meets local health authority requirements and global J&J requirements.
People
Developing a foundation of highly capable, aligned and engaged Business Quality employees in the Local Operating Companies. Manage country & cluster leads for the region. Execute performance management and succession planning processes per J&J Policy.
Compliance
Assures effective processes and adequate resources are in place to deliver a sound compliance profile regionally and locally. Escalate risks to adequate resources to quality executive management. Implement a robust GxP internal, independent audit program to ensure risks are identified and addressed to maintain J&J brand reputation in the local marketplace. Provide Regulatory Compliance (GxP) oversight of all GxP activities within the Local Operating Companies. Ensure consistent and updated quality agreements in region. Ensure regulatory compliance and quality metrics are met; lead the development and implementation of actions to close metric gaps.
Reliable Product Supply Of Safe/Quality Products
Collaborate with SCQA, PQM and CLSQA end to end to enable reliable product supply. Partner with SC to ensure appropriate product supply metrics/targets are established, monitored and met. Ensure SC understands full patient and commercial impact of product shortages in a given market.
Culture Of Quality
Create a culture of quality, helping all cross functional partners in the commercial organization understand how they impact product quality, safety and regulatory compliance.
Requirements
A BA/BS in Life Science, a Technical area, Business, Regulatory Compliance or a related discipline is required. A Master's Degree is desired. At least 10+ years of senior level management experience in a regulated medical industry (Pharmaceuticals, Medical Devices, and / or Diagnostics) is required. A Working knowledge of the business environment inside a quality organization, across various roles (e.g., quality operations, QC, Quality Systems, pre-production quality assurance, validation, market quality, regulatory, etc.) is required. Demonstrated knowledge of applicable regulations within the US (FDA) and outside the US (e.g., ANVISA, Health Canada) is required. Demonstrated experience leading professionals in a matrixed environment is required.
Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, product / process development, customer service, etc.) is desired.
This position can be located in Titusville, Raritan, NJ or Horsham, PA and will require 25% travel both regionally and international.
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