200+ applicants

Company

Esperion · 2 days ago

Manager, Quality Management Systems - Deviation/CAPA

United States

Full-time

Remote

Mid, Senior Level

$116K/yr - $150K/yr

5+ years exp

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Responsibilities

Oversee the end-to-end deviation process, from identification to closure, ensuring that deviations are closed and corrective actions are completed within defined deadlines.

Manage the Corrective and Preventive Actions (CAPA) process, ensuring CAPAs are initiated, investigated and implemented effectively and that appropriate Effectiveness Checks are in place, as needed.

Monitor the effectiveness of CAPA program through follow-up activities, ensuring the preventive actions prevent reoccurrence.

Collaborate with stakeholders to address CAPA effectiveness issues and escalate unresolved issues when necessary.

Serve as the primary point of contact for deviation/CAPA issues or bottlenecks that arise within the process.

Train and support stakeholders relating to the deviation/CAPA process, Investigations including Root Cause Analysis and Risk Assessment, as well as use of Veeva QMS.

Identify trends and recurring issues from deviation and CAPA data, recommending process improvements or preventive actions.

Facilitate and guide teams in conducting thorough root cause analyses for investigations.

Provide guidance and promote the use of problem-solving tools (e.g., Fishbone diagrams, 5 Whys, FMEA) for effective investigations.

Ensure the identification of root causes, contributory factors, and systemic issues for deviations and CAPAs.

Facilitate and guide teams in conducting thorough risk assessments, applying appropriate tools (e.g. FMEA, FaultTree Analysis, HAZOP, etc.).

Provide quality assurance oversight for Computer System Validation (CSV) activities, ensuring that CSV are conducted in compliance with regulatory requirements (FDA, GxP, GAMP) and internal quality SDLC standards.

Support the implementation and review of IT System changes to ensure compliance and that the system remains in a validated state after the changes are implemented.

Partner with IT, system owners and other departments to ensure that CSV requirements are incorporated from system design to decommissioning.

Provide guidance and training to project teams and stakeholders on CSV requirements, risk-based validation, and compliance with regulatory standards.

Qualification

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Quality Management SystemsDeviation/CAPA ManagementRoot Cause AnalysisRisk AssessmentComputer System ValidationGMP RegulationsGCP RegulationsLean MethodologiesSix SigmaVeeva QMSAudit Experience

Required

Bachelor’s degree in Engineering, Life Sciences, or equivalent education and experience.

5+ years of experience in Quality Management Systems with a focus on deviation/CAPA in regulated industries (e.g., pharmaceuticals, medical devices, biotechnology).

Expertise in root cause analysis methodologies and tools (e.g., 5 Whys, Fishbone diagram, FMEA) and handling CAPA processes.

Strong experience in risk assessments, particularly as it relates to deviations, CAPA and Change Controls.

Considerable knowledge/understanding of GMP regulations and industry expectations, as well as knowledge of GCP, GVP and GLP regulations/expectations.

Thorough understanding ICH Q9 and Q10.

Strong analytical and critical thinking skills, with the ability to assess risks and develop effective mitigation strategies.

Solid knowledge of risk-based validation approaches and risk management principles as they apply to CSV.

Excellent communication and interpersonal skills, with the ability to work effectively across departments and with external stakeholders.

Proficient in using Veeva Quality Management System.

Detail-oriented with strong organizational skills, able to manage multiple projects and priorities simultaneously.