Quality Control Ops Lead — Strategic Project PM

Rocket Pharmaceuticals; Cranbury Township (NJ); Sur place; USD 118 000 - 158 000; Plein temps

Avantages offerts par ce poste

Bonuses

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with company match

Paid vacation

Global shutdown days

Wellness resources

Equity awards

Résumé du poste

Rocket Pharmaceuticals is seeking a Senior Manager, Quality Control Operations to lead cross‑functional QC initiatives at our Cranbury, NJ gene therapy facility. You will drive project plans, schedules, risk assessments, and performance reporting while coordinating internal teams and external testing partners.

The role requires strong QC leadership in GxP‑regulated environments, with experience in CAPA, documentation, and continuous improvement.

Qualifications

• Master’s Degree required with 5 years of QC laboratory experience in GxP-regulated biopharmaceutical manufacturing operations.
• Bachelor’s Degree required with 8 years of QC laboratory experience in GxP-regulated biopharmaceutical manufacturing operations.
• Experience in QC capacity management across contract testing laboratories (CTLs).
• Proficiency with Smartsheet and Microsoft tools and established project management methodologies.
• Experience with LIMS, LES, and ELN is preferred.

Responsabilités

• Lead quality-focused projects across cross-functional teams from initiation to completion.
• Develop and maintain comprehensive project plans, schedules, resources, and risks.
• Utilize data to inform prioritization, resource allocation, and project decisions.
• Establish standardized project management methodologies to drive consistency.
• Build and lead cross-functional project teams and ensure timely execution.
• Coordinate contracted laboratory services and external testing partners.
• Facilitate QC project meetings and communicate priorities and deliverables.
• Author and review SOPs, policies, and technical reports.
• Provide training and mentorship in project management and quality processes.
• Oversee QC operational activities including inventory and sample movement.
• Conduct process analyses to identify efficiency improvements and standardization.
• Lead CAPA activities across Quality and QC functions.
• Manage QC investigations, deviations, change controls and CAPAs.
• Support cGMP compliance and regulatory filings.

Connaissances

QC capacity planning

Project management

Stakeholder management

Regulatory knowledge

Results-driven

Smartsheet

Microsoft Excel

PowerPoint

Teams

SharePoint

Project

LIMS

LES

ELN

Formation

Master’s Degree

Bachelor’s Degree

Outils

Smartsheet

Microsoft Excel

PowerPoint

Teams

SharePoint

Project

LIMS

LES

ELN

Description du poste

Rocket Pharmaceuticals is seeking a Senior Manager, Quality Control Operations to lead cross‑functional QC initiatives at our Cranbury, NJ gene therapy facility. You will drive project plans, schedules, risk assessments, and performance reporting while coordinating internal teams and external testing partners.

The role requires strong QC leadership in GxP‑regulated environments, with experience in CAPA, documentation, and continuous improvement.