Quality Operations Project Manager

Position Summary

Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a Quality operations Project Manager with the responsibilities to track all Quality Assurance and Quality control activities and deliverables related to the manufacturing of a range of Gene Therapy products. The incumbent will be responsible to ensure of the direction, coordination, control of all quality operations activities within the manufacturing processes of the company’s diverse programs. 

Primary Responsibilities:

  • Work with the quality team (quality control and quality assurance) to develop strategic planning: scope, goals and deliverables of project are defined
  • Monitor execution of project and prevent out of scope activities
  • This position will work closely with external vendors to define and implement effective project plans
  • Maintain mechanisms to track progress and completion of CMO deliverables during the production of clinical and future commercial Gene therapy products (Starting Materials, Drug Substance and final Product)
  • Manage relationship with external testing laboratories and resolve issues that arise
  • Prioritize assigned product support activities, develop  appropriate timeline
  • Identify areas of risk to product testing and release
  • Create and maintain quality audit schedule including GCP, GLP and GMP
  • Collaborate with project team to propose risk mitigation strategies
  • Deliver program updates to senior leadership as appropriate
  • Drive team accountability for deliverables
  • Manage resources to make sure schedule is on track
  • Facilitate all project team meetings and ensure alignment with project goals
  • Track all activities prior to and during production of clinical and future commercial Gene therapy products (Starting Materials, Media and other critical components used in the manufacture processes)
  • Develop productive relationships with CMOs/CTOs for all products and projects
  • Ensure that release process of stating materials, drug substance and all other components before use in production
  • Work with cross functional peers to meet company’s deadlines
  • Support Quality team for regulatory inspections

Education/Experience and Skills Requirements:

  • BA or BS degree required, Ms or advanced degree preferred in biotech/pharmaceutical industry
  • 5 + years of project management experience in the life sciences
  • Experience in project management, operational planning, and/or contracts management
  • Experience with IND regulatory submissions and early clinical trials; late phase experience is a plus
  • Preferred experience with Gene/Cell therapy products for clinical and commercial
  • Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.
  • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
  • Proficient in relevant project management software: MS Project, SmartSheets, Excel, PowerePoint, Word,… etc

Desired Competencies:

  • Ability to effectively lead and resolve quality issues
  • Ability to develop and execute strategies
  • Ability to prioritize tasks, adapt to shifting priorities and deliver on projects in a timely manner
  • Ability to capture technical discussion in the form of meeting minutes, decision points and action items
  • Handle issues appropriately and with a sense of urgency
  • Strong leadership to support a multi-project environment in small biotech or large pharma
  • Ability to interact, cooperate and motivate across departments and functions

Interested in joining our team?

Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com