Manager, Quality Systems and Risk Management

Responsibilities

• Own and drive formal risk management activities across the organization by leading risk assessments, maintaining risk registers, and applying risk frameworks such as ICH Q9 and FMEA.
• Integrate risk-based thinking into day-to-day QMS activities and serve as the subject matter expert for risk management methodology.
• Support the maintenance and continuous improvement of the QMS.
• Participate in QMS improvement initiatives, including the onboarding and implementation of new Veeva Vault QMS modules, and serve as the procedural subject matter expert for assigned QMS processes, maintaining the associated documentation to reflect current practice and regulatory expectations.
• Manage the preparation and compilation of APQR reports. Play a hands-on role in the APQR process by supporting cross-functional data collection, compiling product review data accurately and thoroughly, and helping ensure timely completion and approval of APQR reports.
• Escalate potential trends and product quality or regulatory compliance issues to management.
• Assist in the generation of Quality metrics and Key Performance Indicators (KPIs) for Quality Management Reviews (QMRs) etc. Analyze and present quality data to identify trends, risks, and opportunities for improvement.
• Collaborate with internal and external key stakeholders for compilation of quality metrics, APQR, etc.
• Aid in executing process improvement initiatives using Lean Six Sigma principles, including data gathering, root cause analysis support, and CAPA follow-through. Contribute to improvement projects aimed at reducing cycle times and enhancing quality system efficiency, and apply Lean Six Sigma tools as part of ongoing quality work.
• Participate in audits and regulatory inspections.
• Ensure all activities comply with current GxP regulatory standards and internal procedures.
• Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations.
• Aid in preparation, review and revision of Standard Operating Procedures (SOPs), as required.

Qualifications

• Bachelor’s degree or equivalent in pharmacy, science, mathematics or engineering required.
• A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained.
• Strong experience and knowledge leading formal risk management activities in a GxP environment, including risk identification, assessment, and mitigation using tools such as FMEA, risk ranking, and ICH Q9 frameworks.
• Knowledge of Lean Six Sigma Methodologies or equivalent is preferred.
• Excellent analytical, problem-solving, and project management skills with keen attention to detail.
• Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP).
• Proficiency in eQMS preferably with prior Veeva experience, Microsoft Office, Excel, Google Docs, etc.
• Experience with commercial marketed products.