The CAPA Manager role is responsible for providing strategic and tactical leadership for all aspects of Non Conformance and CAPA processes, ensuring that compliance and business needs are fully met. This position will also partner with key internal business stakeholders and work cross functionally on continuous improvement activities to drive effective, compliant, and sustainable solutions/ outcomes. Core to these activities will be the ability to effectively manage projects and foster effective interdepartmental and cross-functional partnerships.
• Lead and owner of the Non Conformance and CAPA program. Secures appropriate resources to execute the program compliantly, effectively and efficiently.
• Assists with investigations and resolving compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Develop and implement programs designed to increase employee awareness and knowledge of compliance policies.
• Prepare trend reports related to in-process monitoring, deviation reports, investigation reports and CAPAs.
• Follow-up with functional department for timely completion of corrective and preventive actions recommended.
• May audit and evaluate current policies, procedures, and documentation for compliance with government laws and regulations. Sets strategic direction for the NC and CAPA policies and procedures.
• Provide leadership to support business changes and process improvements. • Ensures company policies and procedures are in place to deliver to the NC and CAPA Quality System and compliance goals and objectives.
• Provides oversight of Quality events (e.g. CAPA and Non-conformance) and Quality Review Board.
• Reviews and as appropriate; approves CAPA plans, implementation and effectiveness checks.
• Leads assessments of high risk areas.
• Supports FDA/3rd Party and internal audits including leading resolving any feedback, observations and addressing any systemic issues.
• Participate designs and maintains up to date NC and CAPA training program.
• Mentors and coaches departmental staff and cross functional teams on all aspects of NC and CAPA management including: processes and procedures, NC/CAPA documentation, Stewardship program requirements etc.
• Performs internal NC/CAPA stewardship reviewed of NC/CAPA documentation, provide feedback to record owners and manager Stewardship program and QPI measures.
• Other duties as assigned
Qualifications Position Requirements:
Knowledge, Skills and Abilities (KSAs)
Previous experience in development and implementation of QA/RA systems in compliance with FDA Quality System Regulation and other applicable international regulations.
Experience in writing SOPs, and other documents.
Leadership skills required; ability to prioritize tasks; level of understanding to pace work completion to the needs of the company.
Strong computer knowledge (MS Office), technical writing skills and proofreading ability
Ability to establish and maintain a structured quality system development process (such as the Define, Develop, Implement, Evaluate and Improve process)
Ability to clearly communicate (both verbal and written), with all levels of the organization
Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail
Must have demonstrated initiative and ability to work independently while handling multiple tasks
Good Knowledge of ISO standards (EN 13485) and regulatory requirements (21 CFR 820 and related regulatory regulations)
Proven ability to motivate employees in a dynamic, evolving, and growing business environment
B.S. degree or equivalent in Scientific or Engineering discipline required
Minimum 8 years’ overall experience with at least 5 years of related experience in Medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on NC/CAPA management activities
Familiarity with FDA, ISO 13485 and multi-country Quality Systems requirements.
Demonstrated ability to interact with all levels of managements, co-workers, and regulator
Must possess strong decision-making and prioritization skills
Must possess strong written, verbal and interpersonal communication skills
Strong organizational skills
Proven track record participating in and/or leading multifunctional “virtual” teams preferred.