Director CQ MedTech Germany/MEA

4 days ago Be among the first 25 applicants

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

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

People Leader

All Job Posting Locations:

Hamburg, Germany, Norderstedt, Schleswig-Holstein, Germany

Job Description

Interne Ausschreibung: 15.04.-29.04.2025

NON-Tarif

Director CQ MedTech Germany/MEA

Under the general direction of the Senior Director Commercial Quality, this position is responsible for establishing and leading Johnson & Johnson's overall quality management framework and quality system for the country/cluster, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities.

The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals. Role complexity includes but is not limited to the ability to interact cross segment and represent the region in global projects and initiatives.

The country/cluster lead is responsible for leading activities towards the integration of the quality management systems for applicable country(ies). This position is responsible for ensuring the QMS requirements are effectively executed in the markets in accordance with local regulations, corporate and segment policies and procedures.

The scope of this role includes the Commercial Quality operations in Germany, UK/IRL, J&J Managed Services (UK), France, Italy, Spain, Russia/CIS, MSMs cluster (Nordics, Benelux, Austria, Switzerland, Portugal, Greece, Israel), CEESAT cluster (CEE, South Africa, Turkey), MEA cluster (Middle East, Africa).

Key Responsibilities

Manage Quality Systems

• Lead the Cluster/Country Commercial Quality organization, including handling, storage, distribution, Level 2 (in-country) customer Service, Technical Service and Repair, and commercial activities, to ensure a proactive approach to quality assurance and quality systems.
• Act as Quality Management Representative as per ISO13485/ISO90001/QMS definition, as applicable.
• Develop appropriate strategic and process performance measures/targets such as delivery service issue management.
• Manage the overall corrective and preventive action (CAPA) and risk management processes.
• Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
• Oversee the management of Standard Operating Procedures, ensuring simplicity, standardization, and education across the cluster/country.
• Operate as a key business partner for quality and process improvement, understanding business requirements.
• Ensure compliance to all applicable quality standards and regulatory requirements.
• Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
• Ensure timely escalation of Quality or Regulatory Compliance Issues.
• Ensure compliant and timely Field Action execution.
• Present case studies and metrics to Cluster/Country Leadership.
• Coordinate/guide execution of internal audit, and external party audit as needed.
• Lead/guide the management review process for the Cluster/Country. Propose initiatives for quality performance improvement.
• Drive complaint vigilance execution in the countries, where applicable, ensuring the timely closure of product related complaints cases, quality, and immediate escalation.
• Understand current requirements of Regulatory Agencies such as local MOH’s, as well as, of standard organizations such as ISO.
• Ensure compliance with the J&J policies and local regulations at LOC, the local warehouses and distributors, including external partners. Liaise with other functional areas as appropriate in the execution of these tasks.
• Establish proper surveillance of the distribution activities (cold chain and loaner kits).
• Work effectively with Cross Segment leadership (functional and commercial) in deploying and sustaining initiatives that support QMS execution and compliance in designated countries.
• Manage Pharmacovigilance and Post Market Surveillance systems within the country/cluster in compliance with local regulations.
• Ensure compliance with Distributor and Importer roles as EU MDR Economic Operator (where applicable).

Strategy and Planning

• Develop a common vision and strategy for Quality and Process Improvement.
• Foster a process improvement culture within the business, implement process management practices, verify/validate project results, and promote further use of Process Excellence.
• Embed QMS management principles in the organization, creating cross-functional process improvement teams to complete projects.
• Engage all employees in these initiatives through coaching, consulting, and change management strategies.
• Develop strategic and process performance measures/targets.
• Represent the region in Local, Regional, and Global forums, leading efforts to achieve results.

Relationship Management

• Partner with the Country/Cluster, Operations, Regional and Functional Community, Business Leaders, Process Owners, and Project Teams.
• Collaborate with external partners and regulators to build capability and ensure compliance.
• Enhance quality & compliance capabilities via training, newsletters, conferences, and quality initiatives.

Special Requirements

Quality EMEA team

Germany: Fulfills the Backup role as Good Distribution Practices (GDP) Responsible Person in case of temporary absence, per German Arzneimittelgesetz (AMG), as Responsible Person (verantwortliche Person nach §52a AMG) for J&J Medical GmbH medicinal products wholesale activities.

Required Qualifications and Core Competencies

This strategic role requires diverse experience, preferably with multiple J&J segments and corporate functions, with specific competencies in quality, regulatory compliance, sales, marketing, QMS, customer service, and distribution. Experience in supporting large, multi-site, global organizations with broad quality management expertise, including regulatory demands across multiple countries and healthcare regulations.

Proven Success In

• Strategy development and project management with measurable results.
• Understanding the quality and regulatory linkage from product development to delivery.
• Driving alignment across health authority requirements.
• Building consensus and influencing outcomes without direct authority.
• Leading diverse organizations and managing risk-based oversight programs.
• Change and project management experience.
• Experience with regulatory agencies like FDA, MHRA, TGA, notified bodies, etc.
• Audit management experience (ISO 9001/13485).
• Developing and coaching teams, driving results.

Education

Bachelor’s or Master’s degree in Bioscience, Engineering, Business, or related field, with 8-10+ years in Medical Device industry and 7+ years in quality/regulatory roles.

Core Competencies

• Decisive, organized, and capable of leading in complex environments.
• Excellent communication, trust-building, and credibility skills.
• Strong presentation and collaboration skills.
• Experience in global/regional contexts preferred.
• Ability to influence and partner effectively across functions.
• Hands-on operational orientation.
• Accountability and change management ability.
• High tolerance for ambiguity.
• Strong relationship, conflict resolution, and team-building skills.
• Fluent in local language and English.

Job location: Norderstedt, Germany.