Director CQ MedTech Germany/MEA

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 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 ability to interact cross segment and representation of the region in global projects and initiatives.

The country/cluster lead is responsible to lead 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 is applicable to the Commercial Quality operating 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:

• 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, understand 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. Liaising with other functional areas as appropriate in the execution of these tasks.
• Establish proper surveillance of the distribution activities (cold chain and loaner kits).
• Effectively work with Cross Segment leadership (functional and commercial) in the deployment and sustainability of initiatives that will support QMS execution and compliance on designated countries.
• Management of Pharmacovigilance and Post Market Surveillance systems within the country/cluster in compliance to 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.
• Entrench a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of Process Excellence to drive business results.
• Embed QMS management principles in the organization, creating cross-functional process improvement teams who effectively complete improvement projects central to these efforts.
• Engage all company employees in these initiatives, through interactive project coaching/consulting and change management strategies.
• Develop appropriate strategic and process performance measures/targets.
• Ability to represent the region in Local, Regional and Global forums, leading functional efforts as required to achieve results.

Relationship Management

• Partner with the Country/Cluster, Deliver Operations, Regional and Functional Community, Business Leaders, Process Owners and Project Teams.
• Work with external business partners and regulators to build capability and ensure compliance to quality standards.
• Strengthen quality & compliance capability in the organization, through tools like trainings, newsletters, conferences, quality month.

Special requirements:

Quality EMEA team

Germany: Fulfils the Back Up 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), (National synonyms: Großhandelsbeauftragter) for J&J Medical GmbH medicinal products wholesale activities.

Required Qualification and Core Competencies for the role:

This strategic role requires a diverse business background, preferably with direct experience in multiple J&J segments and Corporate, with specific quality, regulatory and regulatory compliance competencies in the areas of: Sales, Marketing, MAKE, QMS, customer service, distribution and commercial customer interface. Experience in positions of increasing responsibility supporting large, multi-site, global organizations, with broadly based quality management experience. Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.

Proven success in:

• Strategy development and project management across the organization, with measurable, financial, quality and cycle time results.
• Understanding the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority.
• Driving alignment on strategy and approach across multiple differing health authority requirements.
• Builds consensus and impacts outcome without always having line authority and is able to negotiate trade off decisions across the organization.
• Inspiring and leading across extremely diverse organizations in terms of size, scope, and experience.
• Compliance experience, large-scale QMS experience.
• Experience leading risk-based oversight programs within a segment or Corporate.
• Change management and project management experience.
• Working with an indirect organization that delivers results.
• Issue remediation experience.
• Collaborative approach.
• Managing complexity.
• Strong analytical and strategic skills with a Bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level and detailed, etc.
• Previous experience interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
• Audit Management experience (Health Authorities, Notified Bodies).
• Experienced as audit lead (ISO 9001 and/or ISO 13485 or equivalent).
• Recommended experience in Supplier audit.
• Track record of developing people, leading or coaching teams and driving results.
• DC Q&C management.
• Recommended experience of Process Excellence.

Education

Bachelor’s or Master’s degree in Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality leadership roles, 8 - 10+ years working experience in the Medical Device Industry, 7+ years working experience in quality/regulatory function.

Core competencies required for this role:

• Decisive, organized, and able to lead people within a complex social, cultural and political environment.
• Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• Strong presentation skills.
• Experience working in a global or regional context would be desired.
• Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
• Proven track record of engaging organization and demonstrating collaboration across the organization at all levels.
• “hands-on” operational orientation.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict.
• High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Makes the customer central to all thinking.
• Ability to fit in well culturally in a complex organization.
• Fluent in local language (for country roles).
• Fluent in English.

Job location:

For Germany: Germany (Norderstedt)