Director of Global Quality Assurance Validation
Job Overview
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Director of Global Quality Assurance Validation as part of the Quality team based in Somerset, NJ.
Role Overview
The Director of Quality Assurance Validation role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for facility, equipment, systems, and processes within a cell therapy manufacturing plants to support both clinical and commercial requirements in a sterile GMP environment. This role will have oversight in the US and advise for EU for Quality Assurance Validation and will manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities. This role will collaborate with cross-functional counterparts and manage QAV for Legend commercial and clinical sites.
Key Responsibilities
- Manage team providing quality and compliance oversight for the qualification, validation, process and equipment and facilities maintenance activities within the manufacturing and testing plant.
- Ability to manage multiple and complex validation projects, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
- Provide insight and develop sound strategical approaches to complex investigations and associated CAPAs
- Provide leadership and build an exceptional team to manage the Quality Assurance Validation across multiple sites, including hiring, mentoring and developing personnel.
- Assure the required processes, procedures, systems and resources are in place to ensure a compliant disposition of materials and cell therapy products.
- Collaborate with other leaders across the organization for product life cycle strategy and management of GXP policies, including providing guidance and direction for clinical phase GMP validation and operations.
- Partners with internal and external Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, and Programs.
- Analyzes regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Works in a collaborative team setting with quality counterparts that include Technical Development, Analytical Development, Manufacturing Operations, Engineering and Maintenance, Supply Chain and Planning.
- Other duties will be assigned, as necessary.
Requirements
- A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
- A minimum of 14 years relevant work experience is required. It is preferable that the candidate has 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 manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Proven people management and leadership experience is required.
- Experience working with quality systems is required.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
- Proficient in applying process excellence tools and methodologies.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Experience developing and setting long-term objectives.
- Ability to identify/remediate gaps in processes or systems
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
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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. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: 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 voluntary 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 voluntary 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.