Director of Global Quality Assurance Validation

Legend Biotech US • Somerset, NJ

1d • Hybrid

About The Position

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.

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).

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director