Director Commercial Quality EMEA

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J&J MedTech Vision is recruiting for a Director Commercial Quality EMEA reporting to the Sr Director Global Commercial Quality Vision and to be based in one of the locations within Ireland where the role has been posted.

Job summary

Responsible for overall Quality & Compliance (Q&C) leadership in the relevant region for Johnson & Johnson (J&J) Vision (JJVC and JJSV).

Responsibilities will include government interactions when required, Q&C oversight of Local Operating Companies (LOCs) and commercial entities. This includes all distribution centers, warehouses and third party logistic operations affiliated with J&J Vision for the region of responsibility.

Responsible for implementing and managing the J&J Vision Quality Management System for the Commercial Quality (CQ)organization.

Position will be responsible for all J&J Vision Q&C requirements in the assigned region including compliance to all applicable J&J Enterprise and local government regulatory agency regulations.

Position will partner with J&J global Vision Quality, Supply Chain (SC) and commercial organizations (when required), including partnering with Regional JJVC and JJSV leadership teams to drive continuous improvements in Q&C in their respective region. Position will lead and manage various activities, programs and projects to ensure the achievement of planned quality objectives.

Selects, trains and develops talent to ensure needed successions and bench strength depth and availability of resources to support the QMS objectives development and maintenance. Makes decisions on significant quality and product issues. Prepares department budgets and executes against approved plan(s). Responsible for the management of on-site external agency audits to ensure maintenance of regulatory approvals, licenses, and standards. Position will lead, coordinate and prepare for external audits. Position will partner with J&J Vision global Q&C and SC organizations, and where applicable J&J Enterprise organization (Quality Systems and Regulatory Compliance) to drive continuous improvements in Q&C.

Position will communicate and partner with other CQ professionals in order to implement a worldwide quality management system for JJVC and JJSV. Analyse global trends or early warning signals, and proactively prepare for external/governmental audits. Position will be the VOC for the region for product quality, regulatory compliance. Position will create product quality and compliance Key Performance Indicator(s) specific to the region and implement improvement plans. Position will develop and implement quality procedures specific to the region as necessary.

Finally, this position will adhere to environmental policy and procedures and support department environmental objectives.

Management Representative (Site Management Representative) and Legal Manufacturer Management Representative/Responsible for Regulatory Compliance (PRRC).

Management Representatives appointed to represent a Legal Manufacturer will also serve as the PRRC (for businesses which market products in the European Economic Area (EEA), Turkey (per Customs Union Agreement), and Switzerland.

Requirements

• Bachelors Degree – Technical discipline (e.g. Engineering, Chemistry, Life Sciences, etc.) Advanced Technical Training in DOE, Statistics
• 15+ years working experience in technical / quality / regulatory role in the Medical Device Industry
• Excellent project management and problem-solving skills required
• Excellent communication, interpersonal and organizational skills required
• Excellent understanding and application of principles, concepts and practices of statistical methods preferred
• Strong leadership, coaching skills required
• Demonstrated management abilities required
• Thorough understanding of regulatory / compliance requirements for specific region
• Experienced with direct communications and interactions with end customer/ user
• Flexible in undertaking tasks and working hours
• Ability to use own initiative and make the difficult decisions
• Can lead and drive the changes necessary to support and build the business
• Have full, direct supervisory responsibilities for a department or function
• Under general or minimum supervision, performs duties in terms of stated objectives
• Generally works out details within broad guidelines and exercises considerable initiative and judgment

Note: Any qualification acquired outside the EU, including any university diplomas or certificates, should be from a nationally accredited institution in order to be considered equivalent to the corresponding qualification from an EU member state.

Travel requirement

Up to 20% required

The anticipated base pay range for this position is 104,000 EUR to 179,515 EUR.

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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