Senior Director, Quality Assurance - Commercial & Compliance

Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

Position Summary

The Senior Director, Quality Assurance - Commercial & Compliance leads all aspects of the commercial and compliance requirements for Rocket’s Quality Assurance function.  This includes the following specific areas: training; electronic Quality Management System (eQMS) oversight; supplier management (including the qualification of vendors, supplier change notifications, quality technical agreement management); Commercial Product processes including Product Complaints, Annual Reports, Product Recall.  The role will also be responsible for supporting systems related Quality including:   IT Quality and Data Integrity. The role will also be responsible for all Quality interactions with regulatory health authorities.

Responsibilities

• Establish the compliance and commercial Quality processes to support Rocket Pharmaceutical products and operations.
• These include the recall process, the annual product quality review, biologic product deviation reporting,
• Prepare the organization to host regulatory inspections from FDA, EMA and other Rest-of-World (ROW) health authorities as needed.
• Oversee the electronic Quality Management System (eQMS) as the primary owner and administrator. This includes ensuring the system is validated, processing/evaluating system upgrades, workflows are practical, functional and complaint.
• Establish and maintain the data integrity process and procedures to ensure all electronic data follows regulatory requirements for
• Manage the Quality oversight of computer system validation projects
• Establish and maintain a Quality Plan that describes at a high level the organization of the Quality Management System.
• Establish, maintain and manage the supplier qualification process. This includes managing the quality agreement process as well as the external auditing function.  Supplier Change Notification (SCN) process is also included.
• Oversee paper-based and electronic document control processes, including management of the physical document storage facility and the eQMS document management system.
• Lead the Quality Management Review process, known as the Quality Council, that will collect Quality system metrics and report those periodically to senior management.
• Develop relationships with professional organizations and stay abreast with current Best Practices relevant to QMS.
• Maintain current knowledge of US/EU regulations and quality assurance issues as they impact Rocket’s QMS.
• Establish Quality Council framework and handle customers issues, including “Notice of Significant Events, Recalls, Field Alerts, Escalations, etc.

Qualifications

• Bachelor's Degree in business or scientific/technical field required.
• 15+ years of relevant quality experience in pharma/biotech company
• Minimum 5 years of cell and gene therapy experience
• Experience with commercial Advanced therapy products required
• Prior leadership experience in managing the quality compliance functions
• Broad knowledge and experience with quality assurance and quality systems, quality operations, regulatory compliance and understanding of current US/EU regulatory requirements and trends for manufacturing of Drug Substance, Drug Product and advance therapies (i.e., Cell Gene Therapy)
• Experience interfacing with regulatory health authorities including hosting inspections and responding to observations.
• Understanding of the Quality requirements for commercial distribution of advanced therapy products.
• Experience making strategic Quality decisions, including an understanding of data integrity, strategy, policies, training, and continuous improvement of systems and processes.
• Knowledge of computerized/automated systems and Computer System Validation (CSV).
• Ability to solve organization problems across business units to ensure standardized application of quality systems practices.
• Demonstrates leadership across functions and