Program Manager – GxP CAPA Remediation

Shree Narayani Networking Solutions • Greenville, NC

3d • Onsite

About The Position

The Program Manager – GxP CAPA Remediation leads coordination, execution tracking, and governance for site-level CAPA and remediation workstreams in a regulated pharmaceutical manufacturing environment. This domain-focused program management role oversees a complex portfolio of interdependent activities across Manufacturing, Quality, Validation, MSAT, Engineering, Operations, and other site functions. The Program Manager works with accountable functional owners to maintain progress, manage dependencies, identify risks and delays, facilitate decisions, and drive actions through completion and closure. This is not an IT project management position.

The role includes coordinating remediation activities from planning and initiation through execution, evidence completion, and closure; maintaining alignment on owners, deliverables, milestones, due dates, dependencies, and evidence requirements; tracking progress and following up on commitments; and facilitating cross-functional discussions. The Program Manager maintains action, milestone, risk, issue, decision, ownership, evidence, and closure records; escalates overdue actions and significant risks through established governance channels; and supports leadership decisions and interventions.

The position also prepares concise, fact-based status reporting for site leadership and stakeholders, maintains meeting notes and program records, and supports documentation and traceability in accordance with site procedures and applicable quality-system requirements. The Program Manager partners with Quality and functional owners to support timely, compliant CAPA execution and closure within the site’s established GxP and Quality Management System framework. The role is onsite in Greenville, South Carolina, and is listed with a duration of 9+ months.

Requirements

• 10+ years of Program Management, Project Management, or Workstream Management experience in pharmaceutical manufacturing, biotechnology, medical devices, or another regulated life-sciences manufacturing environment.
• 5+ years of 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 with multiple interdependent workstreams and working directly with Manufacturing, Quality, and technical or operational stakeholders at a regulated manufacturing site.
• Ability to manage multiple actions, milestones, dependencies, risks, issues, and stakeholders; facilitate meetings and decisions; follow up on commitments; escalate risks and delays; and prepare concise leadership-level status reports. Must be willing and able to work onsite in Greenville, South Carolina.

Nice To Haves

• Direct experience with CAPA remediation, regulatory inspection remediation, audit remediation, quality-system remediation, or comparable regulated change initiatives.
• Experience managing remediation programs arising from regulatory observations, internal or external audits, quality events, investigations, or compliance improvement initiatives.
• Experience in pharmaceutical manufacturing functions such as Manufacturing Operations, Quality, Validation, MSAT, Engineering, or other GxP functions.
• Familiarity with remediation governance, action-management processes, risk management, and evidence-based closure.
• Experience as a consultant, contractor, or partner Program Manager embedded at a pharmaceutical manufacturing site.
• Experience coordinating senior stakeholders and functional subject-matter experts in a matrixed environment.
• Subject-matter expertise relevant to the assigned remediation domain; final domain requirements depend on workstream assignment.

Responsibilities

• Coordinate assigned CAPA and remediation workstreams from planning and initiation through execution, evidence completion, and closure.
• Maintain alignment among accountable owners, deliverables, milestones, due dates, dependencies, evidence requirements, and site objectives.
• Track actions against committed dates, follow up with accountable owners, and identify delays, execution risks, dependencies, and resource constraints.
• Coordinate activities across Manufacturing, Quality, Validation, MSAT, Engineering, Operations, and other site functions; clarify sequencing, handoffs, and responsibilities.
• Facilitate working sessions and cross-functional discussions, document decisions and next steps, and escalate overdue actions, risks, and resource conflicts through established governance channels.
• Maintain accurate action, milestone, risk, issue, decision, ownership, evidence, and closure records; prepare concise leadership status updates and support compliant GxP documentation and traceability.

What This Job Offers

• Career Level: Senior
• Education Level: No Education Listed