Consultant - Quality & Compliance
Quality Management Specialist
Support client projects involving Quality Management Systems (QMS), GxP compliance, quality operations, and continuous improvement initiatives.
Assess quality processes, procedures, documentation, and workflows to identify compliance gaps, inefficiencies, risks, and opportunities for improvement.
Develop, revise, review, and maintain SOPs, work instructions, quality plans, process maps, quality records, and controlled documentation.
Support quality system activities including deviation management, CAPA, change control, document control, training management, and nonconformance investigations.
Participate in the implementation, maintenance, and improvement of quality management systems to ensure compliance with regulatory and organizational requirements.
Support internal audits, supplier audits, mock inspections, and regulatory inspection readiness activities, including tracking corrective and preventive actions.
Collect, analyze, and report quality metrics, KPI data, compliance trends, and project information to support quality improvement and informed decision-making.
Prepare client-ready deliverables including assessments, gap analyses, status reports, dashboards, training materials, implementation documentation, and executive summaries.
Participate in process mapping workshops, continuous improvement sessions, stakeholder interviews, and cross-functional meetings to support project objectives.
Manage assigned project tasks, timelines, action items, and deliverables, ensuring quality execution and timely completion of workstreams.
Monitor project risks, issues, and dependencies and escalate concerns appropriately to project leadership and client stakeholders.
Conduct regulatory and industry research to support client recommendations and maintain awareness of evolving quality and compliance requirements.
Contribute to development of quality tools, templates, best practices, internal process improvements, and knowledge-sharing initiatives.
Act as a subject matter resource within assigned areas of expertise and provide informal guidance and support to team members when appropriate.
Perform other duties and responsibilities as assigned.
Bachelor's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, Quality, Regulatory Affairs, Clinical Research, or a related scientific discipline. Advanced degree and/or relevant quality, regulatory, project management, Lean Six Sigma, or continuous improvement certification is preferred.
Minimum 4-7 years of experience in Quality Assurance, Quality Systems, Compliance, Clinical Quality, Manufacturing Quality, Regulatory Quality, Clinical Operations, Regulatory Affairs, or a related life sciences discipline.
Experience within pharmaceutical, biotechnology, medical device, CRO, CDMO, or life sciences consulting environments.
Experience supporting quality systems, audits, inspections, CAPA, deviations, change control, training, document management, and compliance initiatives.
Demonstrated ability to independently manage assigned workstreams, solve complex problems, and deliver high-quality project outcomes.
Working knowledge of GxP requirements, applicable regulations, quality standards, and industry best practices.
Knowledge of Quality Management Systems, Quality Assurance principles, GxP requirements, and life sciences regulatory expectations.
Experience with CAPA, deviations, change control, quality records management, audit programs, inspection readiness, and compliance activities.
Ability to analyze data, identify quality risks, evaluate root causes, and recommend practical solutions.
Strong technical writing skills with the ability to prepare SOPs, quality documentation, reports, assessments, and client deliverables.
Proficiency in Microsoft Office applications and familiarity with eQMS, LMS, document management systems, audit management systems, and related quality tools.
Strong project coordination and organizational skills with the ability to manage multiple priorities simultaneously.
Experience supporting process optimization, operational excellence, Lean, Six Sigma, or change management initiatives.
Experience participating in quality system implementations, remediation projects, compliance improvement initiatives, or inspection readiness programs.
Strong communication and stakeholder management skills with the ability to work effectively across client and internal teams.
Demonstrated ability to work independently, apply sound judgment, and provide guidance within an established area of expertise.
Prior consulting experience in life sciences quality, compliance, regulatory, or operational excellence environments is preferred.
