Senior Investigation Quality Leader (1 of 2)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson and Johnson is seeking a Senior Investigation Quality Leader, located in Athens, GA.

The Senior Investigation Quality Leader is responsible to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations). This includes, but is not limited to, providing quality, compliance, and technical feedback/ regarding quality and manufacturing investigations ensuring compliance to company policies while contributing to continuous improvement efforts.

Key Responsibilities:

• Lead/Participate in investigation processes such as initial triage, initial impact assessment, investigation strategy meetings, root cause and CAPAs alignment meetings.
• Identify support function required to support the investigation process. Provides guidance on documentation content and requirements in support of investigations.
• Write/review/approve investigation reports using a narrative based on process science and scientific knowledge that supports the identified root cause or most probable cause.
• Train investigators and cross-functional team members on the standard methodologies to write investigation reports that are factual, clear, coherent, concise, complete, compliant.
• Apply 6-sigma principles to the investigation process to identify root cause or most probable cause (5-why, 6M, affinity diagrams, brainstorming, etc.). Applies critical thinking to discern relevant information to the investigation report.
• Contribute to the design of CAPAs aligned to root cause that are effective in preventing recurrences. Assign CA-PA with reasonable timeframes, track due dates, reviews closing evidence and approves closure.
• Ensure that investigation process adheres to timelines to ensure approval in 30 calendar days. Leads improvement process for the reduction of investigations and/or design of effective CAPAs.
• Approve investigations (initial impact assessment, investigation report) as delegated by supervisor.
• Responsible to follow J&J Innovative Medicine Policies, site procedures, Regulatory Agencies and Safety & Environmental regulations.
• Collaborate with other departments and team members to provide guidance and support during investigations and the development of CAPAs to resolve quality issues and ensure timely closure of investigations.
• Escalate compliance issues to the Quality Investigation Supervisor.

Qualifications

Education:

• Bachelor’s degree in a scientific field is required.

Experience and Skills:

Required:

• A minimum of four (4) years of experience writing and approving investigations including designing/approving CAPAs.
• Thorough understanding of Quality Systems Regulations, cGMP/GLP regulations, ICHQ7, and FDA requirements for pharmaceutical and medical devices.
• High level of understanding of industry expectations for nonconformance, root cause analysis, corrective and prevent actions (end-to-end CAPA process).
• High understanding of cGMP, Good Documentation Practices, and Regulations. Familiarity with US and International GMPs for pharmaceuticals.
• Good analytical skills, strong problem solving and decision-making abilities.

Preferred:

• Demonstrated experience in root cause analysis, CAPA management, and quality management systems.
• Excellent analytical, problem-solving, and d