CAPA Manager at Cornerstone TTS
About the Job
Cornerstone TTS is seeking a highly skilled CAPA Manager to lead the Corrective and Preventive Action (CAPA) process for our client. This role is pivotal in driving product and process performance improvements, identifying and addressing nonconformances, and ensuring the effectiveness of the CAPA process and related systems.
Location: 100% Remote (Candidates must reside in one of the following states: FL, AZ, IN, NC, SC, KY, GA, TX)
Location: 100% Remote (Candidates must reside in one of the following states: FL, AZ, IN, NC, SC, KY, GA, TX)
Key Responsibilities:
- Provide leadership in the CAPA process, focusing on product and process improvements.
- Monitor and respond to escalated issues within the war room setting as per the major incident management SOP.
- Document high-level actions taken in response to issues to facilitate review and improvement of response effectiveness.
- Manage multiple high-priority tasks while maintaining clear and accurate communication and documentation.
- Recognize the need for issue escalation and execute necessary communication and follow-up actions.
- Perform data queries to support enterprise-wide requests.
- Facilitate multiple teams in determining Root Cause using standard data gathering and problem-solving methodologies.
- Monitor open CAPA activities and intervene as necessary to ensure their completion.
- Ensure accuracy of system entries and the integrity of distributed information.
- Maintain data integrity of PHI-related information.
- Respond promptly to emails and other communications.
- Uphold professional accountability during challenging discussions.
- Assist in establishing metrics to measure CAPA process effectiveness.
- Collaborate with cross-functional teams to ensure correct issue ownership, closure of CAPA action items, and effectiveness of closure.
- Ensure the CAPA program meets all applicable requirements and regulations, including ISO 9001:2015.
Qualifications:
- Lean Six Sigma training preferred (Green or Black Belt).
- Knowledge of quality systems based on ISO 9001:2015 or similar standards.
- Expertise in the pharmaceutical, healthcare, and/or pharma healthcare consulting industry with a focus on software development, data, and quality systems.
- Strong experience with Corrective Action and Preventive Action processes and Root Cause problem-solving methodologies.
- Ability to work effectively at all organizational levels, up to senior management.
- Excellent organizational, planning, critical thinking, and problem-solving skills.
- Strong statistical and analytical skills.
- Exceptional communication and documentation skills.
- Project management experience.
- Flexibility and adaptability.
- Ability to work independently with minimal supervision.
- Proficiency in using computers and digital devices daily.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to develop presentations.
- Preferred technical knowledge and understanding of software development and infrastructure.
Technical Proficiencies:
- Strong meeting facilitation skills.
- Proficient in Jira, Confluence, Excel, Visio, Word, PowerPoint, ServiceNow, Outlook, OneNote, and Teams.
- Familiarity with Agile/Scrum framework.
- Expertise in Root Cause Analysis methodologies (e.g., 5 Whys, Cause and Effect Diagramming).
- Experience in creating process flows (Standard and Swim Lane).
Join us at Cornerstone TTS to lead the CAPA process for our client, ensuring continuous improvement and excellence in product and process performance.
Salary
45 - 50 /hour