Senior Project Manager (Remediation SME)
About the role
Position Summary: We are seeking an experienced Senior Project Manager (Remediation Subject Matter Expert) to lead and manage complex quality, compliance, and regulatory remediation initiatives within a GMP-regulated pharmaceutical, biotechnology, or medical device environment. The ideal candidate will possess extensive experience in remediation programs, regulatory compliance, quality systems, CAPA management, inspection readiness, and cross-functional project leadership. This role will be responsible for driving remediation strategies from assessment through implementation while ensuring adherence to regulatory requirements and business objectives.
Key Responsibilities :Lead enterprise-wide remediation programs resulting from regulatory inspections, internal audits, quality assessments, and compliance gap analyses .Develop and execute comprehensive remediation strategies, project plans, timelines, budgets, and resource allocation plans .Conduct assessments of Quality Systems, Manufacturing Operations, Laboratory Operations, Validation Programs, and Data Integrity processes to identify compliance risks and improvement opportunities .Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Engineering, Validation, Supply Chain, and Laboratory teams to define remediation priorities .Establish governance structures and project management frameworks to track remediation activities and deliverables .Drive the development, implementation, and effectiveness monitoring of Corrective and Preventive Actions (CAPAs) .Ensure remediation activities align with FDA, EMA, MHRA, ICH, PIC/S, and global GMP regulatory expectations .Prepare executive-level status reports, dashboards, risk assessments, and progress updates for senior leadership and stakeholders .Facilitate risk management activities and proactively identify project risks, mitigation strategies, and escalation pathways .Lead cross-functional workshops and working sessions to resolve compliance issues and accelerate remediation efforts .Support regulatory inspections, agency interactions, and responses to regulatory observations, warning letters, and consent decree commitments .Monitor project milestones, key performance indicators (KPIs), and remediation effectiveness metrics .Drive continuous improvement initiatives to strengthen quality systems and sustain long-term compliance .Mentor project teams and provide subject matter expertise on GMP compliance, quality systems, and remediation best practices
. Required Qualification s:Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or a related fiel d.10+ years of experience in pharmaceutical, biotechnology, medical device, or other highly regulated industrie s.7+ years of project management experience leading large-scale remediation, quality transformation, or compliance initiative s.Strong knowledge of GMP regulations, Quality Systems, CAPA processes, Data Integrity requirements, Validation lifecycle, and regulatory inspection managemen t.Demonstrated experience managing remediation programs related to FDA inspections, Warning Letters, Consent Decrees, or significant compliance observation s.Proficiency in project management methodologies and tool s.Strong leadership, stakeholder management, communication, and problem-solving skill s.Ability to manage multiple projects and cross-functional teams in a fast-paced environmen
t.
Not the right fit? Search for Project Manager jobs in Ottawa, Ontario, Canada
About United Consulting Hub
United Consulting Hub is a leading provider of comprehensive validation services, including Equipment Validation, Process Validation, Computer Systems Validation, Utilities Validation, and Facilities Validation. We also specialize in offering top-notch Quality Assurance, Quality Control, and Microbiology services. With our expertise and commitment to excellence, we assist our clients in ensuring compliance with regulatory requirements and achieving the highest standards of quality, ensures seamless processes and superior outcomes.
Our team of experienced professionals is committed to delivering exceptional results, adhering to stringent quality standards and industry regulations. Whether you need assistance with validation, formulation, analytical testing, quality control, quality assurance, microbiology lab set-up, cell and gene therapy facilities or regulatory affairs, we have the expertise and resources to support your project from inception to market launch.
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Senior Project Manager (Remediation SME)
About the role
Position Summary: We are seeking an experienced Senior Project Manager (Remediation Subject Matter Expert) to lead and manage complex quality, compliance, and regulatory remediation initiatives within a GMP-regulated pharmaceutical, biotechnology, or medical device environment. The ideal candidate will possess extensive experience in remediation programs, regulatory compliance, quality systems, CAPA management, inspection readiness, and cross-functional project leadership. This role will be responsible for driving remediation strategies from assessment through implementation while ensuring adherence to regulatory requirements and business objectives.
Key Responsibilities :Lead enterprise-wide remediation programs resulting from regulatory inspections, internal audits, quality assessments, and compliance gap analyses .Develop and execute comprehensive remediation strategies, project plans, timelines, budgets, and resource allocation plans .Conduct assessments of Quality Systems, Manufacturing Operations, Laboratory Operations, Validation Programs, and Data Integrity processes to identify compliance risks and improvement opportunities .Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Engineering, Validation, Supply Chain, and Laboratory teams to define remediation priorities .Establish governance structures and project management frameworks to track remediation activities and deliverables .Drive the development, implementation, and effectiveness monitoring of Corrective and Preventive Actions (CAPAs) .Ensure remediation activities align with FDA, EMA, MHRA, ICH, PIC/S, and global GMP regulatory expectations .Prepare executive-level status reports, dashboards, risk assessments, and progress updates for senior leadership and stakeholders .Facilitate risk management activities and proactively identify project risks, mitigation strategies, and escalation pathways .Lead cross-functional workshops and working sessions to resolve compliance issues and accelerate remediation efforts .Support regulatory inspections, agency interactions, and responses to regulatory observations, warning letters, and consent decree commitments .Monitor project milestones, key performance indicators (KPIs), and remediation effectiveness metrics .Drive continuous improvement initiatives to strengthen quality systems and sustain long-term compliance .Mentor project teams and provide subject matter expertise on GMP compliance, quality systems, and remediation best practices
. Required Qualification s:Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or a related fiel d.10+ years of experience in pharmaceutical, biotechnology, medical device, or other highly regulated industrie s.7+ years of project management experience leading large-scale remediation, quality transformation, or compliance initiative s.Strong knowledge of GMP regulations, Quality Systems, CAPA processes, Data Integrity requirements, Validation lifecycle, and regulatory inspection managemen t.Demonstrated experience managing remediation programs related to FDA inspections, Warning Letters, Consent Decrees, or significant compliance observation s.Proficiency in project management methodologies and tool s.Strong leadership, stakeholder management, communication, and problem-solving skill s.Ability to manage multiple projects and cross-functional teams in a fast-paced environmen
t.
Not the right fit? Search for Project Manager jobs in Ottawa, Ontario, Canada
About United Consulting Hub
United Consulting Hub is a leading provider of comprehensive validation services, including Equipment Validation, Process Validation, Computer Systems Validation, Utilities Validation, and Facilities Validation. We also specialize in offering top-notch Quality Assurance, Quality Control, and Microbiology services. With our expertise and commitment to excellence, we assist our clients in ensuring compliance with regulatory requirements and achieving the highest standards of quality, ensures seamless processes and superior outcomes.
Our team of experienced professionals is committed to delivering exceptional results, adhering to stringent quality standards and industry regulations. Whether you need assistance with validation, formulation, analytical testing, quality control, quality assurance, microbiology lab set-up, cell and gene therapy facilities or regulatory affairs, we have the expertise and resources to support your project from inception to market launch.