Project Manager – GxP

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.

This is a domain-focused program management role, responsible for managing a complex and interdependent portfolio of remediation activities across Manufacturing, Quality, Validation, MSAT, and other site functions. The Program Manager will work closely with accountable functional owners to maintain momentum, manage dependencies, identify risks and delays, facilitate decisions, and drive actions through completion and closure.

The successful candidate will bring strong experience in pharmaceutical or regulated life-sciences manufacturing, GxP quality systems, CAPA/remediation programs, cross-functional coordination, and site-level program governance.

This is not an IT Project Manager position. Candidates should have direct experience managing programs, remediation initiatives, or complex workstreams within pharmaceutical, biotechnology, medical device, or comparable regulated manufacturing environments.

Key Responsibilities

CAPA & Remediation Program Management

• Coordinate assigned CAPA and remediation workstreams from planning and initiation through execution, evidence completion, and closure.
• Establish and maintain clear 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 or execution risks.
• Drive assigned actions to completion by maintaining disciplined follow-up with accountable functional owners.

Cross-Functional Coordination

• 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 required to resolve issues and progress remediation activities.
• Make timely follow-up calls, document decisions, confirm action owners, and ensure clear next steps following meetings.
• Build effective working relationships with site stakeholders and maintain strong engagement across workstreams.

Governance, Risk & Issue Management

• Maintain accurate tracking of:
  • CAPA/remediation actions
  • Milestones and due dates
  • Dependencies
  • Risks and issues
  • Decisions
  • Action owners
  • 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 or interventions required to maintain program progress.
• Ensure issues are assigned clear ownership and actively managed through resolution.

Status Reporting & Stakeholder Communication

• Prepare concise and accurate status updates for site leadership and program stakeholders.
• Clearly communicate:
  • Overall remediation progress
  • Completed and outstanding actions
  • Upcoming milestones
  • Exceptions and overdue activities
  • Key risks and dependencies
  • Decisions or leadership support required
• Maintain accurate meeting notes, action records, decision logs, and supporting program documentation.
• Provide fact-based reporting that enables leadership to quickly understand program health and areas requiring attention.

GxP Documentation & Traceability

• 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 closely with Quality and functional owners to support timely and compliant CAPA execution and closure.
• Promote consistent program-management practices while operating within the site's established GxP and Quality Management System (QMS) framework.

Required Qualifications

• 10+ years of demonstrated 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/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 confidence 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 reporting.
• 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/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 SMEs in a matrixed environment.
• Specific subject-matter expertise relevant to the assigned remediation domain(s) is preferred; final domain requirements will depend on the workstream assignment.

Key Skills

GxP | CAPA | Pharmaceutical Manufacturing | Quality Systems | Remediation Programs | Program Management | Workstream Management | CAPA Governance | Risk & Issue Management | Action Tracking | Cross-Functional Coordination | Manufacturing | Quality | Validation | MSAT | Stakeholder Management | Audit/Inspection Remediation | Regulatory Compliance | Documentation & Traceability | Executive Status Reporting

Ideal Candidate Profile