Role Overview The Sr. QA Validation Specialist, CSV & Equipment role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity. Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site Review and approve qualification/validation documentation (specifications, protocols, reports) Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration) Provide expertise and solutions to issues regarding qualification and validation strategies and documentation Provide guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems Assist in the development of validation and qualification related policies, procedures, templates, forms Provide quality oversight on data integrity of systems, instruments, and equipment used at the site Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations Interact with colleagues in Quality and Technical Services to assess and guide the deployment of systems at the CAR-T Raritan Site Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements Drive continuous improvement Provide training and guidance to other members of the team Other duties may be assigned, as necessary Requirements A minimum of a Bachelor’s Degree in Science or equivalent technical discipline is required 7+ years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus Strong knowledge of GxP compliance Experience in cGMP regulatory body audits Strong interpersonal and written/oral communication skills Ability to quickly process complex information and make critical decisions with limited information Ability to work independently and be responsible for a portfolio of ongoing projects Ability to pay attention to details and follow procedures closely Ability to identify and assess possible gaps and work collaboratively to address such issues Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision Experience reviewing/auditing GMP documentation Strong proficiency with using Microsoft Office applications Compensation and Benefits The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is $123,605 USD - $162,232 USD. Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy. #J-18808-Ljbffr