Director, Quality Assurance Systems

About the role

The Director of Digital Systems Quality Assurance (DSQA) is responsible for establishing, leading, and continuously improving the quality oversight of GxP digital systems supporting gene therapy manufacturing, pharmaceutical development, and analytical laboratories. This role ensures that computerized systems, data integrity controls, and digital workflows meet global regulatory requirements, internal quality standards, and lifecycle management expectations. This position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global and site GxP systems for Gene Therapy manufacturing, quality control, warehouse, including the NJ Research Development Location as necessary. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents.

Responsibilities

• Experience with Veeva systems, LIMS (e.g., Labware), Chromatography Data Systems (e.g., Waters Empower, Nugenesis, Thermo Chromeleon), and/or Electronic Lab Notebooks (ELN) is required.
• Ensure deployed solutions are in alignment with business needs, in compliance with Data Integrity requirements.
• Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders.
• Provide oversight to the implementation and validation of GxP software applications/modules and associated interfaces according to business needs and internal procedures (support system upgrades, change control, retrospective validation, software add-on installations where capable).
• Work with project teams and business/quality representatives to ensure compliance with regulatory requirements such as FDA, EMEA, PMDA, CAPAs, GxP, etc.
• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
• Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.
• Provide support during regulatory inspections and internal audits.

Requirements

• A Bachelor's degree and a minimum of 10 years of relevant Quality Assurance experience. An advanced degree (MS) and a minimum of 5 years relevant experience will also be considered.
• Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..
• PREFERRED: Experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA
• Excellent communication skills (verbal and written).
• Demonstrate ability to manage projects and variable workloads.
• Highly organized with a strong attention to details, clarity, accuracy, and conciseness.

Qualifications

• Must have working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.
• Must demonstrate leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities.

Skills

• Experience with Veeva systems, LIMS, Chromatography Data Systems, and/or Electronic Lab Notebooks.
• Experience with GxP regulations and reporting requirements.
• Experience with Computer System Validation and quality management tools.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP).

Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.

401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance.

Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.

Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Pay

$177,000.00-242,000.00 Annual

Schedule

Hybrid role based out of our San Diego office. You’ll work remotely most of the time, with in-person collaboration when it matters most.

Location

San Diego, CA