Europe, Middle East, Africa (EMEA) Commercial Quality Head

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine   

Position Summary:

• This position provides leadership, oversight, and/or support to Q&C activities in Local Operating Companies, Distribution Centers, Third Party Logistics providers, Transportation, and Customer Service functions, facilitates collaboration across the Q&C community within the region and champions initiatives aimed at ensuring that the region is well represented in global / enterprise forums and that capabilities are in place to meet the strategic growth projections in the region.

• This role is responsible for establishing and leading regional quality and compliance management and promotes a process improvement culture within the business to ensure trusted quality products and services are available in the countries every day. In partnership with Commercial and Deliver Supply Chain, 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 Regional Commercial and Deliver leadership teams to enable growth in the commercial business. The Regional Head of Commercial Quality serves as the single point of contact with regional Commercial and Deliver for all quality and compliance-related issues and matters and represents Quality & Compliance (Q&C) on the Regional Commercial and Deliver Board.

• This position serves as the Quality leader on the Regional Commercial Quality Leadership Team and reports directly to the Global VP of Commercial Quality at Johnson & Johnson with a dotted line to the Company Chairman of Johnson & Johnson Innovative Medicine EMEA.  As such, the position represents EMEA in the Global Commercial Quality Leadership Team.

• This position serves as a Janssen Cilag International Board member (Marketing Authorization Holder for EU/EEA centrally approved products) and Janssen Sciences Ireland Board member with focus on risk management and quality oversight (including PRRC for Clinical studies that include an investigational device where JSI is listed as the Device Manufacturer).

You will be responsible for:

Oversee Management of Quality & Compliance

• Provide end-to-end quality and compliance leadership across marketing, storage, distribution activities and serve as voice of quality and Quality Management Representative on the Regional Commercial and Supply Chain leadership teams.

• Embed effective and inspection-ready quality management system into the relevant business processes from new product introduction, complaint management of customer complaints, field actions, vigilance reporting, distribution, delisting, etc.  in collaboration with R&D, Supply Chain, Regulatory Compliance, Health Care Compliance, Medical Affairs, Safety, Marketing, Legal, etc. and ensure compliance to local Health Authority requirements, corporate Quality Policies and relevant Enterprise and Segment Quality Standards.

• Partner and collaborate with both Global and Regional Regulatory Affairs organizations, industry and professional organizations to ensure timely gathering, shaping, assessment of upcoming/new/revised regulatory requirements (regional and local) while sustaining country specific commercial activities. Execute Quality System & compliance strategies including implementation of new or changed health authority requirements, transparent escalation of non-compliances and risks.

• Engage and provide guidance on the resolution of critical compliance and quality events that could impact product quality or supply interruption.

• Ensure that Quality and Compliance strategy and oversight is a proactive consideration in all relevant segment strategy development such as: network optimization; Continuous Improvement Programs; facility, process, and organizational transitions or changes; outsourcing decisions related to raw materials, suppliers, and distributors, third party transport/logistics, and labor; creation and maintenance of digital assets; Research Related Activities, etc. Ensure consistency of approach and use of standard Quality and Business processes.

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Risk Management

• Advocate for our patients/consumers; ensuring appropriate, comprehensive, risk- based quality decisions are made 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 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 and ensure appropriate reporting of AEs, PQCs and Device Malfunctions.

• Ensure risk to patient and product availability are integrated into the quality decision-making process.

• Connect with Regulatory Compliance, R&D Quality, Supply Chain Quality 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 and Deliver organization.

Enabling Business Growth

• Enable product launch into local markets; ensuring quality and regulatory compliance risks are mitigated prior to product launch.

• 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, R&D Quality, Product Quality Management, Regulatory Affairs 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.

Qualifications/Requirements:

• Minimum required education: BS or Master degree in Business Administration, Science/Regulatory/Compliance related.

• 15+ years of senior level management experience in a regulated healthcare industry (Pharmaceuticals, Medical Devices, consumer and / or Diagnostics).

• People Management Experience: minimum 10 years required.

• Ability to effectively communicate and translate technical requirements to commercial functions and key stakeholders.  

• Ability to influence and deliver quality results through key functional partners. 

• Capable of managing complexity across the business to consistently deliver customer expectations while meeting health authorities’ requirements.

• Process Excellence (Lean, six sigma, etc.) experience across diversified business areas or equivalent quality standards programs.

• Relevant experience in the healthcare or pharmaceutical industry is essential along with supply chain, compliance, project management and change management experience.

• Strong leadership capabilities and a proven track record of leading or coaching teams to achieve significant quality and process improvements.

• Led teams through change, preferably across different geographies.

• Strong people development capabilities with examples of promotions and successful talent import/export.

• Proactive, have excellent influencing and interpersonal skills with the ability to identify, implement and manage multiple priorities.

Travel: 30%

This role has to be on site in one of the locations of the local operating company or Distribution Center, as it requires constant interaction with multiple stakeholders.  It requires travel to the different local operating companies.

Preferred locations are: Belgium, Ireland, UK, France, Germany, Italy, Netherlands, Switzerland, South Africa, Poland.  Additional locations might be considered: Portugal, Israel, Bulgaria, Croatia, Serbia, Slovenia, Lithuania, Latvia, Estonia, Lebanon, Syria, Algeria, Morocco, Ghana, Kenya, Nigeria, Romania, Turkey, Ukraine, Czech Republic, Slovakia, Russia, Kazakhstan, Hungary, Austria, Spain, Denmark, Finland, Norway, Sweden, Greece, Saudi Arabia, UAE, Egypt.