Senior Director, Quality Assurance - Commercial & Compliance

Rocket Pharmaceuticals•Cranbury, NJ

About The Position

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.

Requirements

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 organizational levels.
Demonstrates the ability to incorporate sound risk management fundamentals in the establishment of QMS.
Demonstrates excellent interpersonal verbal and written communication.

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.