VP Global Commercial Quality, J&J Pharmaceutical Sector

仕事内容

Summary Of The Role

This position serves as the head of Global Commercial Quality for the J&J Pharmaceutical Sector. This position reports directly to the Chief Quality Officer for the J&J Pharmaceutical Sector. With the members of the Global Commercial Quality Leadership Team, the incumbent is responsible for developing and deploying the Commercial Quality Strategic Plan and assuring the integration/alignment of the commercial quality strategy with the strategies of the Regional Commercial Leadership Teams/ Boards, the Pharmaceutical Sector GOC, and the Pharm Sector and J&J Enterprise Q&C organizations. Ensures the strategy and organization evolve to meet the needs of a high growth pharmaceutical business to include Pharmaceuticals, Biologicals, Vaccines, Combination Drug/Device products, New Modalities, Technology Solutions, Digital Health, and Services.

Job Scope

The role of the VP of Global Commercial Quality is to ensure the products and services in commercial distribution meet the requirements of global health authorities and J&J Standards, Policies and Procedures within the distribution centres, third party logistics and local markets in which Janssen (the J&J Pharmaceutical Sector) commercially markets and distributes products. This role provides direct end to end oversight of quality for Janssen products and services in the Local Operating Companies and through partnerships with Supply Chain Quality, R&D Quality, as well as R&D and Commercial business functions.

Quality System And Process Ownership And Oversight

• The VP of Global Commercial Q&C owns the non-Supply Chain quality processes including Management Review for Management with Executive Responsibility; Escalation to Management of issues potentially impacting product quality, safety and/or compliance with global regulations; Quality Review Board; Field Action; Product Risk Management; and Product Discontinuance.
• He/she directly manages the product complaint vigilance process and ensures integration of the complaint vigilance process end to end from intake through product quality complaint and adverse event trending and reporting.
  
  

Roles And Responsibilities

• Serve as an advocate for our patients; 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 Janssen does business is safe, of high quality and fully compliant with local health authority requirements. Chair the Quality Review Board; lead the QRB process and executive level communication of QRB decisions for Janssen globally. Ensure alignment of all QRB members; escalate to Chief Quality Officer when the QRB members are not fully aligned on actions for a given issue.
• Ensure all policies for approval of and execution of Health Authority Notifications are followed appropriately in partnership with Legal, Global RA and JJRC.
• Ensure market actions such as Market Withdrawal/Recall and related actions are taken in a timely manner and are communicated through the Escalation to Management process.
• Communicate with key partners across Q&C, R&D, Commercial and SC regarding emerging risks to product safety, product quality or compliance with global health authority requirements and communicate those risks through the Escalation to Management Process to ensure Management with Executive Responsibility for our products and their functional team members are fully informed of the risks, impacts, and actions taken throughout the product lifecycle.
• Execute a patient and business focused Quality Management Review at multiple levels to include: the Local Operating Companies, Regional Management of the Local Operating Companies, and Group Operating Committee.
• Lead the Product Risk Management process to assess, control, communicate and review risks to patients and users of J&J products through the Product Quality Group risk management process. Escalate risks to Management per J&J Standards and Policies.
• Escalate quality-related risks with new products to Management per J&J Standards and Policies.
• Implement and execute a Quality Management System and tools into the Local Operating Companies; integrating existing and new regulations into the Quality Management System to enable a favorable compliance profile with global and local health authorities which meets the requirements defined in J&J Enterprise and Pharm Sector Standards, Policies, and Procedures. Ensure all Commercial Quality team members and key partners in RA, Medical Safety and Medical Affairs, and Deliver in the regions are trained on the Quality Management System.
• Collaborate with J&J Enterprise QA Systems to develop and enhance standardized Quality Standards, Polices, Procedures and Technologies.
• Oversee the development and deployment of CAPAs to improve the execution of key processes and systems such as labeling and copy/graphics, web-based promotional materials, and digital healthcare applications within the Pharm Sector.
• Direct the Complaint Vigilance program for Janssen globally. Assure the integrity of the compliant/AE intake process and execution of the end-to-end Compliant vigilance process including MDR reporting to global health authorities. Oversee the Complaint Vigilance Review Board and ensure effective CAPAs are opened and executed to address safety and/or product quality complaint trends in a timely manner.
• Develop a foundation of highly capable, aligned and engaged Commercial Quality employees which maximizes the strengths of its members. Ensure a robust performance planning process and succession planning process are in place for the Commercial Quality team globally in each region and local operating company.
• Lead the Global Commercial Quality Leadership team; facilitate the development of the Global Commercial Quality Strategy, Goals and Objectives; ensure alignment with the Business, SC and R&D and J&J Enterprise Q&C strategies.
  
  

Qualifications

Background and qualifications:

• Education: minimum required BA/BS (Life Science / Technical) - preferred: MA/MS/MBA (Business / Reg Compliance).
• Minimum overall 15 years of related experience, at least 10-12 years of senior level Quality Management experience in a regulated medical industry (Pharmaceuticals, Medical Devices, and / or Diagnostics).
• Strong track record of making key product and process decisions given in depth experience in demonstrating solid judgement in complex situations and ambiguous circumstances.
• 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.).
• Demonstrated knowledge of applicable regulations in regions (e.g., FDA, ANVISA, MHRA, MHLW, etc.).
• Demonstrated experience leading professionals in a matrixed environment.
• Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, product / process development, customer service, etc.).
  
  

Competencies Required

• 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, Supply Chain, 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 Commercial Quality specifically, and J&J more broadly. In-depth experience in dealing with regulatory inspections and inspectional requirements.
  
  

Travel: 20-30%

This is a global role that supports 61 LOC’s covering 162 countries and can be located at any of these sites.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location

United States-New Jersey-Raritan-1000 US HIghway 202

Other Locations

Europe/Middle East/Africa-Ireland, North America-United States, Europe/Middle East/Africa-Switzerland, Asia Pacific-Singapore, Europe/Middle East/Africa-Belgium

Organization

Janssen Pharmaceuticals, Inc. (6062)

Job Function

Quality

Requisition ID

2206081905W