RA and BQ Expert – Nigeria at Johnson & Johnson

LOC Regulatory and Business Quality Manager (m/w) (100%)

Johnson & Johnson is currently recruiting for a LOC Regulatory and Business Quality Manager (m/w) based in Lagos, Nigeria.

Company Background & Culture

Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products, and services to advance health and well-being. 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. J&J has more than 250 companies located in 60 countries around the world.

Who is Janssen

Are you passionate about crafting a world without disease? Do you have expertise in Regulatory Affairs and Passion for Quality? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. Join us!

Role Purpose

The successful candidate will act as the local regulatory expert for all therapeutic areas as well as be the Quality Executive for LOC. The jobholder plays a key role in the cross-functional country value teams and will report into the LOC Regulatory Head Near East & SSA / dotted line to LOC Quality Head.

Key Responsibilities:

RA Role (50% time)

1. Act as a RA Expert for the corresponding country, for all Therapeutic Areas (TA)
2. Support maintenance of marketed products
3. Liaison and main contact between LOCs and global groups (Therapeutic Areas teams, CMC teams, Labeling teams, Regulatory Quality teams)
4. Provide regulatory support for daily business and products supply in accordance with J&J guidelines and local laws & regulations
5. Act as LTR for JNJ Nigeria office

BQ Role (50% time)

1. Responsible for the GxP (including GMP/GDP) Quality of, and meeting the applicable requirements for, the products and services marketed by the Local Operating Company ‘LOC’/ Cluster (including all named-patient materials NPP/ SPR process and PSP activities)
2. Supervise compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GxP activities the LOC/ Cluster undertakes
3. This position is also responsible for the continuous improvement of the GMP/ GDP and Quality system status of the LOC/ Cluster
4. Oversee the quality and compliance status of all third parties, distributors and other J&J organizations engaged by the LOC/ Cluster for the GxP activities for the LOC/ Cluster
5. Support the preparation, execution and follow-up for the internal & external inspections for the LOC/ Cluster

Qualifications

• Pharmaceutical or scientific university degree
• Significant experience (~3-5 years) in Regulatory affairs within the pharmaceutical industry and a proven track record of outstanding approvals
• Experience in working in Quality assurance or Market Access is a plus
• Reliable, positive, energized, and self-motivating personality, team-player
• Strong communication and presentation skills with the ability to convert complex data in simple messages, diplomacy, and interpersonal adaptability
• Ability to adapt communication style based on audience and situation
• Integrity and transparency
• Fluency in English

Other:

Travel requirements:

• RA Role ~ 10% to attend global meetings
• BQ Role ~ 10% to attend global meetings

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.