Business Quality and Regulatory Compliance Director / Medical – Emerging Market – Johnson & Johnson 51 views

Business Quality and Regulatory Compliance Director / Medical – Emerging Market – Johnson & Johnson


Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Business Quality Director will be reporting to the Senior Director, Business Quality & Regulatory Compliance, EMEA Functional group:Business Quality (BQ) and have 5 Direct reports QRC Leads in Central East Europe (CEE), Middle East (ME), Maghreb-Iran-Sub-Saharan Africa (MISSA) and South Africa (SA) Overall purpose of job: 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.
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.
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.
With $70.1 billion in 2015 sales, Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets.
Proud to be an equal opportunity employer.
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.
Essential duties and responsibilities: 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.
Johnson & Johnson Johnson & Johnson Services, Inc. is recruiting for a Business Quality and Regulatory Compliance Director Medical Devices to be located in Dubai . Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.
And our culture is interconnected by the shared values of Our Credo . It’s a culture that celebrates diversity and diverse perspectives.
We embrace research and science — bringing innovative ideas, products and services to advance the health and well-being of people.
It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
The Regional Head of Business Quality serves as the single point of contact with commercial for all quality and compliance-related issues and matters.
There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.

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