Consultant - Quality & Compliance

ProductLife Group; United States; On-site; USD 125,000 - 145,000; Full time

Job summary

ProductLife Group is seeking an experienced Quality Consultant to join our growing team in the life sciences sector. You will support QMS, GxP compliance, quality operations, and continuous improvement initiatives across client projects.

You will assess processes, develop SOPs and quality documentation, manage CAPA and deviations, and contribute to audits, inspections, and performance dashboards. Strong writing and project coordination are essential.

Qualifications

• Bachelor's degree in life sciences or related field.
• Advanced degree or certification in quality/regulatory/PM or Lean Six Sigma preferred.
• Experience in life sciences quality and regulatory environments.

Responsibilities

• Support client projects involving QMS, GxP compliance, quality operations, and continuous improvement initiatives.
• Assess processes and documentation to identify compliance gaps, risks, and improvement opportunities.
• Develop, review, and maintain SOPs, work instructions, quality plans, and quality records.
• Support quality system activities including deviations, CAPA, change control, document control, training management, and nonconformance investigations.
• Participate in implementation and continuous improvement of QMS and regulatory compliance.
• Assist audits, mock inspections, inspection readiness activities, and tracking CAPA actions.
• Collect and report quality metrics, KPIs, and compliance trends for decision-making.
• Prepare client deliverables like assessments, gap analyses, reports, dashboards, and executive summaries.

Education

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

Tools

eQMS

LMS

Document management systems

Job description

ProductLife Group is looking for an experienced Quality Consultant to join our growing team. If you're passionate about quality, compliance, and delivering impactful solutions in the life sciences industry, we'd love to hear from you.

Specific Activities & Responsibilities:

• Support client projects involving QMS, GxP compliance, quality operations, and continuous improvement initiatives.
• Assess processes, procedures, documentation, and workflows to identify compliance gaps, risks, inefficiencies, and improvement opportunities.
• Develop, review, and maintain SOPs, work instructions, quality plans, process maps, quality records, and controlled documentation.
• Support quality system activities including deviations, CAPA, change control, document control, training management, and nonconformance investigations.
• Participate in the implementation, maintenance, and continuous improvement of QMS and support regulatory compliance.
• Support audits, mock inspections, inspection readiness activities, and tracking of corrective and preventive actions.
• Collect, analyze, and report quality metrics, KPIs, compliance trends, and project data to support quality improvement and decision-making.
• Prepare client deliverables including assessments, gap analyses, reports, dashboards, training materials, implementation documents, and executive summaries.
• Participate in process mapping workshops, stakeholder interviews, continuous improvement initiatives, and cross-functional meetings.
• Manage project tasks, timelines, deliverables, risks, issues, dependencies, and action items, escalating concerns as appropriate.
• Conduct regulatory and industry research to support client recommendations and stay current with evolving requirements.
• Contribute to quality tools, templates, best practices, process improvements, and knowledge-sharing initiatives.
• Serve as a subject matter resource, providing guidance to team members as appropriate.
• Perform other duties and responsibilities as assigned.

Required education:

• 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.

Required experience :

• Minimum 5-7 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

Required technical skills:

• 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

Additional experience and/or skills:

• 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.

Compensation range: USD 125 to 145K

The compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate's experience, skills, qualifications, and internal compensation policies, in accordance with applicable pay transparency and requirements.