Project Manager, Quality & Operations

RTD Biosciences • Full-time • North Charleston, SC, US • 2m ago

Project Manager, Quality & Operations

RTD Biosciences | Charleston, SC

About the Role

RTD Biosciences is seeking a Project Manager, Quality & Operations to support complex, multi-workstream initiatives across quality, compliance, and facility operations at our manufacturing facilities. This role works within the PMO and partners closely with senior project managers and operational leadership to execute high-priority projects at the facility level. The ideal candidate brings hands-on experience in regulated manufacturing environments and is eager to grow their expertise across regulatory compliance, infrastructure execution, and cross-functional coordination.

You are organized, detail-oriented, and proactive. You know how to keep workstreams moving, escalate blockers early, and communicate clearly with both operational teams and leadership. You thrive in fast-moving environments and are ready to take on increasing ownership as you grow in the role.

Roles & Responsibilities

• Support end-to-end project management for facility-level initiatives spanning quality systems, regulatory compliance, infrastructure, and workforce development

• Partner with senior PMs and the GM to translate strategic priorities into structured, executable project plans with clear milestones, owners, and deliverables

• Manage concurrent workstreams across quality, operations, and facilities, maintaining fidelity on scope, timeline, and dependencies

• Develop and maintain project documentation including SOPs, work plans, status reports, and gate review materials in alignment with PMO standards

• Coordinate cross-functional stakeholders including Quality, Regulatory, Operations, and external vendors or contractors

• Identify, track, and escalate risks, gaps, and blockers proactively; maintain visibility for senior leadership on project health

• Support facility expansion and build-out activities, helping manage vendors, timelines, and compliance requirements

• Assist in change management efforts associated with quality system implementations, facility upgrades, and operational transitions

• Ensure all project activity is executed in alignment with applicable regulatory frameworks including 503A, 503B, Annex 1, and cGMP requirements

• Support HR and department leads with workforce planning, onboarding coordination, and training program rollout tied to operational initiatives

Qualifications

Required

• 4+ years of project management experience, with at least 2 years in a regulated pharmaceutical or sterile manufacturing environment

• Working knowledge of Annex 1, CMC, cGMP, 503A, and/or 503B compliance requirements

• Hands-on experience supporting projects in sterile injectable or compounding manufacturing facilities

• Demonstrated ability to manage multiple concurrent projects with strong attention to detail and follow-through

• Solid proficiency in project management methodologies; PMP certification a plus

• Strong written and verbal communication skills; comfortable presenting project status to operational and cross-functional audiences

• Adaptable and organized in fast-moving, build-phase environments

Preferred

• Experience supporting facility design, construction, or commissioning projects in a regulated environment

• Exposure to quality management system (QMS) implementation or remediation

• Background in analytical laboratory or compounding pharmacy facility operations

Apply

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