ESPERION THERAPEUTICS INC
Manager, Quality Management Systems - Deviation/CAPA
ESPERION THERAPEUTICS INC, Ann Arbor, Michigan, us, 48113
Company Overview
Our Mission:
At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.
Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Quality Philosophy:
Quality is in all we do because all we do is for our patients.
Esperion’s passion for quality is an integral part of our company culture and is embedded in every aspect of the organization. We are committed to applying the highest quality standards to develop and deliver safe, effective pharmaceutical products that significantly improve the quality of life for the patients and clinical trial participants we serve.
Position Title: QMS Manager – Deviation/CAPA
The primary role of the QMS Manager is Business Process Owner (BPO) for the Deviation/CAPA program at Esperion. This colleague will be responsible for managing, coordinating and optimizing the Deviation and CAPA process within Esperion’s QMS. The manager will work closely with cross-functional teams, ensuring that root cause analyses are thorough, that corrective measures are effective in preventing recurrence and records are resolved timely.
The ideal candidate will also bring working knowledge of computer systems validation to the role to support 21CFR11 compliance and maintenance of the validated state of computer systems used to support processes governed by the Predicate Rules.
This role reports to the Head of Quality Management Systems.
Preferred Location: Remote – US
Essential Duties and Responsibilities*
Deviation/CAPA Business Process Owner:
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.
Root Cause Analysis & Risk Assessment
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.).
QA Oversight of CSV
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.
Qualifications (Education & Experience)
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 of ICH Q9 and Q10.
Strong analytical and critical thinking skills, with the ability to assess risks and develop effective mitigation strategies.
Certifications in Quality Management Systems (QMS), Six Sigma, or Lean methodologies preferred.
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.
Experience with audits and inspections is a plus.
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Our Mission:
At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.
Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Quality Philosophy:
Quality is in all we do because all we do is for our patients.
Esperion’s passion for quality is an integral part of our company culture and is embedded in every aspect of the organization. We are committed to applying the highest quality standards to develop and deliver safe, effective pharmaceutical products that significantly improve the quality of life for the patients and clinical trial participants we serve.
Position Title: QMS Manager – Deviation/CAPA
The primary role of the QMS Manager is Business Process Owner (BPO) for the Deviation/CAPA program at Esperion. This colleague will be responsible for managing, coordinating and optimizing the Deviation and CAPA process within Esperion’s QMS. The manager will work closely with cross-functional teams, ensuring that root cause analyses are thorough, that corrective measures are effective in preventing recurrence and records are resolved timely.
The ideal candidate will also bring working knowledge of computer systems validation to the role to support 21CFR11 compliance and maintenance of the validated state of computer systems used to support processes governed by the Predicate Rules.
This role reports to the Head of Quality Management Systems.
Preferred Location: Remote – US
Essential Duties and Responsibilities*
Deviation/CAPA Business Process Owner:
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.
Root Cause Analysis & Risk Assessment
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.).
QA Oversight of CSV
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.
Qualifications (Education & Experience)
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 of ICH Q9 and Q10.
Strong analytical and critical thinking skills, with the ability to assess risks and develop effective mitigation strategies.
Certifications in Quality Management Systems (QMS), Six Sigma, or Lean methodologies preferred.
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.
Experience with audits and inspections is a plus.
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