Specific Responsibilities: Manage and oversee the Corrective Action and Preventive Action (CAPA) system and process activities.
Provide support/responses during audits/inspections relating to the CAPA and NC system as required. Develop and deliver CAPA process training as required to ensure the appropriate level of the process knowledge is maintained. Remain conversant with the appropriate regulations, laws and standards to maintain CAPA process compliance and provide up-to-date guidance and training. Ensure effective CAPA data analysis and root cause investigation, and evaluate trends.
As the chair of the Tarrytown CAPA Review Board ensure compliance to requirements and the consistency/quality of CAPA documentation. Drive timely execution of CAPA tasks through monitoring and reporting of metrics to CAPA owners and management. Periodically interface with site management, peers and work teams to assess and improve the adequacy of the CAPA process. This includes but is not limited to the remediation of CAPA system deficiencies noted in audits and/or inspections.
Secondary Responsibilities: This role will be that of individual contributor, with no direct reports, however, the person is responsible and will be charged with effective coordination of teams and groups who have been assigned to work on CAPA issues. The ability to effectively influence is paramount in this role. The candidate is responsible for the overall direction, coordination and evaluation of the CAPA process and support teams.
Responsibilities include planning, assigning, and directing work; appraising performance; rewarding and providing guidance to employees and teams; addressing CAPA issues and resolving problems. To the extent possible, this individual will also serve as the subject matter expert as it relates to the CAPA process.
Job Knowledge Criteria: Fundamental knowledge and complete understanding of CAPA and NC system regulations and standards (e.g. ISO 9001, ISO13485, FDA 21 CFR Part 820) Proven effective leadership and influencing skills. Provide leadership and direction, championing departmental or cross-functional CAPA initiatives and teams. Good teamwork and interpersonal skills. Provide project direction, coaching, and mentoring for QS and non-QS personnel.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving CAPA issues. Provide weekly, monthly, quarterly and annual report of the state of the CAPA process. Provide a source for issue escalation that provides feedback to Senior Management. Serve as a mentor by providing technical guidance in identifying and resolving CAPA issues. Foster continuous improvement and consistent metrics to achieve business results and quality output.
Use technical/compliance information to guide and influence CAPA compliance strategies. Strong project management and organizational skills are needed. Excellent verbal and written communication skills Strong analytical and problem solving skills are necessary. Excellent attention to detail is important.
A technical degree in engineering, science or related discipline, 10 - 15 years of medical device/ drug development experience required, and a minimum of 5 years of direct, hands-on CAPA management experience.
Demonstrated used of Quality tools/methodologies - root cause analysis, risk management, investigation, and FDA and ISO standards.
Demonstrated interpersonal skills, with ability to work within a team environment. Strong written/verbal communication skills.
Proficiency in all Microsoft Office suite.
Six sigma problem solving methodologies preferred.
ASQ certification pr