Manager Commercial Quality MedTech Saudi Arabia Johnson and Johnson

The country lead is responsible to lead activities towards the integration of the quality management systems for Saudi Arabia. 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.

Manage Quality Systems

• Lead the Saudi Commercial Quality organization, including Saudi Distribution center for handling, storage and distribution to respective Markets in Distribution network, customer Service and commercial activities, to ensure a proactive approach to quality assurance and quality systems.
• Act as Quality Management Representative as per ISO13485/ISO9001/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.
• Ensures timely escalation of Quality or Regulatory Compliance Issues.
• Ensures compliant and timely Field Action execution.
• Present case studies and metrics to Saudi Leadership.
• Coordinate/guide execution of internal audit, and external party audit as needed.
• Support the management review process for MEA Cluster. 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 (loaner kits)
• Ensure compliance with Distributor role as EU MDR Economic Operator.
• 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, Supply Chain organization (Ops, D&T, and CS), 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:

For Medicinal Products

In aspects of Pharmacovigilance (PV) the CQ Lead may act as Local PV Point of Contact.

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.