This role is responsible for overall Quality & Compliance Leadership in the Emerging Markets Marketing Companies to ensure high quality products and services are available in the Emerging Markets region. The Regional Head of Business Quality serves as the single point of contact with commercial for all quality and compliance-related issues and matters.
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Ensure timely and consistent escalation of events
Ensure compliance to all applicable quality standards & regulatory requirements, coordinating the timely and effective deployment of J&J Standards requirements
Establish and lead J&J/MD&D/EMEA‘s QM framework in the Emerging Markets region
Embed Quality Management System (QMS) management principles in the countries organization & drive continuous improvement
Establish corrective & preventive actions to mitigate potential or actual non-compliance risk
Drive simplification & standardization of QS in the region in line with J&J/MD&D strategies & initiatives
Track corrective action plans and mitigation/remediation plans for External Audits (Notified Bodies, Health Authorities etc), JJRC audits & QScan
Set Business Quality (BQ) targets, ensure effective flow down and monitor performance
Supervising the Field Actions and Complaints management in CEE, coordinating with Regulatory Affairs the notification to local Competent Authorities. Management of Pharmacovigilance per local country and J&J Franchise requirements (as applicable)
Develop, lead and maintain an comprehensive audit readiness program for the EMEA region to ensure internal and external compliance
Connect with the leaders in the region to align on strategy for audits in the region
Demonstrate Leadership behaviors expected by J&J Credo and Leadership Principals
Drive accountability for compliance to foster a compliance driven culture
Establish local and regional relationships with RA, business partners and internal/external QRC groups
Build and further develop capabilities in the region to enable flawless execution & good business outcomes
Create a leadership structure and team to cover the Emerging Markets, in line with J&J POL-001 requirements
Develop a robust QRC structure in the region and drive change as needed to enhance capability
Connect with the business leaders in the region through active participation as the Quality representative for Emerging Markets in relevant Quality Councils and Leadership meetings
Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meeting
Other features of the job:
This role must maintain a close working relationship with regional Commercial organization, with inclusion of specific Goals & Objectives related to current business priorities.
Attendance at local Commercial meetings is essential
Job location:
BQ MD Emerging Market Director may be based preferably based in either the UK or Dubai.
Qualifications
Educational:
Bachelors or Master’s degree in Bio Science, Engineering or Business or equivalent field coupled with relevant business experience in Quality leadership roles
10+ years working experience in the Medical Device Industry
7+ years working experience in quality/regulatory function
Recommended experience of Process Excellence
Audit Management experience (Health Authorities, Notified Bodies)
Experienced as audit lead (ISO 9001 and/or ISO 13485 or equivalent)
Recommended experience of Supplier audit
Track record of developing people, leading or coaching teams and driving results
Change management experience and influencing and interpersonal skills
Experience working in a global or regional context would be desired
Strong collaboration skills and ability to build partnerships internally and externally
Excellent written and oral English communication skills are required
Ability to effectively present information to Management and public groups is required
Core competencies required for this role:
Leadership in accordance with J&J principles and values
Strong Quality System knowledge and understanding of Regulatory Compliance requirements for relevant market
Strong business partnership with Commercial Leadership with understanding of Business needs and activities.
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