CAPA Lead - QA

Job description

Job Description

The CAPA Lead - Quality Assurance (QA) is responsible for providing oversight of all Quality Assurance activities related to the Houston CAPA process including but not limited to CAPA process training/mentoring programs, CAPA documentation review/approval processes, effectiveness check management, nonconformance/CAPA trending activities and routine metrics reporting, training and system access.

Major Accountabilities:
•Manages and oversees functional processes for the CAPA System and Metrics Reporting. Monitors and evaluates assigned systems and procedures to ensure industry standards and cGMPs are met. Metrics reporting to include monthly Cockpit, CAPA Board and quarterly MRB metrics, and Quality Council metrics. Daily CAPA review and reporting to assure proper assessment and assignment of local issues.
•Develops and delivers robust site CAPA Process training to include certification program for both site Investigators, Reviewers and Quality Assurance Approvers.
•Provides oversight of non-conformance investigations and implementation of corrective and preventive actions while assuring there are adequate product and process controls in place for identified CTQ’s.
•Leads team interactions with other functional areas (i.e. Quality, Operations, Engineering, Supply Chain, and Laboratory) to ensure unfavorable trends are identified, addressed, and resolved.
•Acts as a Quality Assurance SME for the investigative process and CAPA System and drives initiatives to identify and solve technical and procedural deficiencies to improve productivity and compliance.
•Leads initiatives for tracking of metrics, CAPAs, etc. This includes collecting more information for clear reporting of those items trending unfavorably and escalating to management as appropriate.
•Audits, mentors and calibrates personnel working within the CAPA system in order to achieve and maintain a high level of understanding of the process and expected outcomes.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Education requirements
Minimum: B.S. Engineering or Sciences (e.g. Chemistry, Physics, etc.)
Preferred: M.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.), Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA)

Experience Requirements
Minimum: 2 years of experience/involvement in CAPA processes including but not limited to non-conformance investigations, corrective/preventive actions, and verification of effectiveness.
Preferred: 3-5 yrs experience in regulated industry for Medical Device, Pharmaceuticals or equivalent.
Thorough knowledge of cGMP and ISO regulations.
Experience in project management with project management certification preferred.
Thorough knowledge and experience in Trackwise software preferred.
Understanding of LEAN and six sigma principles with Green Belt or Black Belt certification preferred.
Certified Quality Investigator (Internal Applicants Only).