Janssen Ortho LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Manager Investigations and Corrective and Preventive Actions (CAPA) to be located in Gurabo, PR.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Quality Manager Investigations and CAPA you will:
• Provide direction to the Senior Quality Investigations & CAPA Specialists to ensure that the Investigations and CAPA systems are in control.
• Facilitate, assess, evaluate, approve and manage site investigations and CAPA records.
• Provide comments and recommend corrective actions.
• Implement the investigation policy at Gurabo’s site.
• Ensure investigations’ completeness/accuracy and that they are conducted per policies and procedures and in compliance with all regulatory requirements by providing guidance/consulting assistance to the areas impacted.
• Measure corrective actions effectiveness, present a monthly trend report to management, and lead investigations meetings.
• Assure true root cause is identified and assure effective CAPA plans are known, implemented and that effective use of Quality Risk Management tools is taking place.
• Support the Annual Product Review and Quality System Management Review Programs.
• Liaison person between sister companies around the world in relation to Quality Investigation and Internal complaints.
• Assist in Food and Drugs Administration (FDA) and other regulatory inspections, including foreign inspections.
Qualifications
• A minimum of a Bachelor’s degree in Science or Engineering is required.
• ASQ Certified Quality Auditor (CQA) certification is preferred.
• At least five (5) years of experience in the Quality Assurance Unit within the pharmaceutical industry (i.e. consumer, medical device, consumer) is required.
• Experience working or leading investigations and CAPA is required.
• Exposure presenting and interacting with regulatory agency representatives is highly desirable.
• Previous supervisory experience is required.
• Proficiency in Microsoft Office programs (PowerPoint, Word, Excel and Outlook) is required. is preferred.
• Ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment is required. The candidate must have strong analytical problem solving, strategic thinking, change management and interpersonal, leadership, influencing, and presentation skills.
• Must be fully bilingual (English and Spanish, oral and written).
• This position requires up to ten percent (10%) of travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location
United States-Puerto Rico-Gurabo- Organization
Janssen Ortho LLC (2162)
Job Function
Quality
Requisition ID
7157200623
