Role Overview

The Director of Quality Operations, CAR-T is responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. The role develops and implements long-term and execution of Quality programs. This role will also be responsible for trending of quality operations metrics and developing continuous improvement initiatives for the team and processes. The Director also manages a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities.

Key Responsibilities

• Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements.
• Partners with other Legend functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
• Responsible for all aspects of incoming and final product disposition for the site.
• Responsible for batch record review activities for the site.
• Oversees quality shop floor program to ensure compliance of the manufacturing operations.
• Responsible for providing quality oversight of the QC laboratory.
• Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
• Manages team of senior managers and professionals within Quality. Hires and develops employees within the department.
• Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
• 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.
• 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.

Pay Range (Base Pay):

$193,629-$254,137 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.