Job Summary
We are seeking an experienced Program Manager - GxP CAPA Remediation to lead the coordination, execution tracking, and governance of site-level Corrective and Preventive Action (CAPA) and remediation workstreams within a regulated pharmaceutical manufacturing environment. The role involves managing complex and interdependent remediation activities across Manufacturing, Quality, Validation, MSAT, Engineering, Operations, and other site functions. The Program Manager will work closely with accountable functional owners to manage dependencies, identify risks and delays, facilitate decisions, maintain execution momentum, and drive remediation activities through completion and closure. This is a domain-focused program management position requiring direct experience in pharmaceutical or regulated life-sciences manufacturing, GxP quality systems, CAPA/remediation programs, and site-level governance. This is not an IT Project Manager position.
Key Responsibilities
• Coordinate assigned CAPA and remediation workstreams from planning and initiation through execution, evidence completion, and closure.
• Establish and maintain alignment across accountable owners, deliverables, milestones, due dates, dependencies, and evidence requirements.
• Maintain an integrated view of multiple remediation activities and ensure individual workstreams remain aligned with overall site objectives and timelines.
• Track remediation actions against committed dates and proactively identify potential delays and execution risks.
• Drive assigned actions to completion through disciplined follow-up with accountable functional owners.
• Coordinate activities across Manufacturing, Quality, Validation, MSAT, Engineering, Operations, and other relevant site functions.
• Ensure sequencing, dependencies, handoffs, and responsibilities between functional teams are clearly understood.
• Facilitate working sessions and cross-functional discussions to resolve issues and progress remediation activities.
• Conduct timely follow-up discussions, document decisions, confirm action owners, and establish clear next steps following meetings.
• Build effective working relationships with site stakeholders and maintain engagement across workstreams.
• Maintain accurate tracking of CAPA/remediation actions, milestones, due dates, dependencies, risks, issues, decisions, action owners, and evidence and closure requirements.
• Identify schedule slippage, unresolved dependencies, resource constraints, and emerging risks before they impact remediation commitments.
• Escalate overdue actions, significant risks, resource conflicts, and cross-functional dependencies through established governance channels.
• Support leadership in identifying decisions and interventions required to maintain program progress.
• Ensure issues have clear ownership and are actively managed through resolution.
• Prepare concise and accurate status updates for site leadership and program stakeholders.
• Communicate overall remediation progress, completed and outstanding actions, upcoming milestones, overdue activities, key risks, dependencies, and decisions or leadership support required.
• Maintain accurate meeting notes, action records, decision logs, and supporting program documentation.
• Provide fact-based reporting to help leadership understand program health and areas requiring attention.
• Support disciplined documentation and traceability of remediation activities in accordance with site procedures and applicable quality-system requirements.
• Ensure remediation actions, decisions, evidence expectations, and completion status are appropriately documented.
• Partner with Quality and functional owners to support timely and compliant CAPA execution and closure.
• Promote consistent program-management practices within the site's established GxP and Quality Management System (QMS) framework.
Required Qualifications
• 10+ years of Program Management, Project Management, or Workstream Management experience within pharmaceutical manufacturing, biotechnology, medical devices, or another regulated life-sciences manufacturing environment.
• 5+ years of strong working knowledge of GxP requirements and regulated Quality Management Systems.
• 5+ years of practical understanding of CAPA processes, remediation activities, quality events, action tracking, evidence requirements, and closure processes.
• Experience managing or coordinating complex remediation programs involving multiple interdependent workstreams.
• Experience working directly with Manufacturing, Quality, and technical or operational stakeholders within a regulated manufacturing site.
• Demonstrated ability to manage multiple actions, milestones, dependencies, risks, issues, and stakeholders simultaneously.
• Strong meeting facilitation and stakeholder-management skills, with the ability to drive decisions and actions.
• Strong follow-up and execution discipline, with the ability to hold accountable owners to agreed commitments.
• Ability to identify and escalate risks, delays, dependencies, and resource conflicts in a timely manner.
• Excellent written and verbal communication skills, including the ability to prepare concise leadership-level status reports.
• Ability and willingness to work on-site in Greenville, South Carolina, and build effective relationships with site teams.
Preferred Qualifications
• Direct experience supporting CAPA remediation, regulatory inspection remediation, audit remediation, quality-system remediation, or comparable regulated change initiatives.
• Experience managing remediation programs resulting from regulatory observations, internal or external audits, quality events, investigations, or compliance improvement initiatives.
• Experience working within pharmaceutical manufacturing areas such as Manufacturing Operations, Quality, Validation, MSAT, Engineering, or related GxP functions.
• Familiarity with remediation governance, action-management processes, risk management, and evidence-based closure.
• Experience operating as a consultant, contractor, or partner Program Manager embedded within a pharmaceutical manufacturing site.
• Experience coordinating senior stakeholders and functional subject matter experts in a matrixed environment.
• Specific subject-matter expertise relevant to assigned remediation domains.
Key Skills
• GxP, CAPA, pharmaceutical manufacturing, quality systems, and remediation programs.
• Program management, workstream management, and CAPA governance.
• Risk and issue management, action tracking, and cross-functional coordination.
• Manufacturing, Quality, Validation, and MSAT.
• Stakeholder management, audit and inspection remediation, and regulatory compliance.
• Documentation, traceability, and executive status reporting.
