Sr. Manager, CQA GLP

Legend Biotech is seeking a Manager/Sr. Manager, GLP - CQA as part of the Regulatory Affairs team based in Somerset, NJ.

Role Overview

The incumbent/appointee will be responsible for ensuring that the relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities’ guidance/principles, and/or EDD’s established quality standards. He/she will maintain a compliant quality system to meet these requirements, and will be responsible for the overall (GLP) quality oversight of studies, from the assessment of external vendors via audits to their onboarding. The appointee will oversee the overall laboratory processes by reviewing and/or supporting the development of SOPs, and supporting the bioanalytical assays that are required for the GLP or CGLP studies. She/he may be involved in overseeing the work performed by external contract research organizations (CROs) and/or consultants.

It is expected that the appointee will have a broad knowledge of GCP/ICH guidelines in order to support cross-functional teams and provide input in GCP/GLP processes; in fact, he/she will partner with the study teams in order to maintain and/or reinforce a ‘quality culture’, thus contributing to Legend Biotech’s inspection-readiness goal. 

The appointee is expected to be local (Somerset, NJ) and be on a hybrid work schedule (i.e., 2-3 days working at the Somerset, NJ, site.

The incumbent will report to the Sr. Director of Clinical Quality Assurance.

Key Responsibilities

• Support the GLP quality compliance systems, via established policies and procedures for the GLP QA function.
• Manage GLP quality systems including the implementation and maintenance of procedures and standards. Support documentation review activities, when necessary or required to ensure compliance.
• Support/perform audits of external vendors that provide GLP related services. The ‘audit’ includes all activities, from the set up of the agenda, confirmation letter, review of vendor’s SOPs, etc. to the timely (30 days’ target) filing of the audit report and other relevant documentation in the Veeva system.
• Support the process of GCP/GLP deviations from study protocols or standard operating procedures.
• Support internal and external GLP study audits and general laboratory compliance audits to ensure that laboratories, internal and external are adhering to all quality protocols and regulations.
• Collaborate with the GLP’s relevant functions in reviewing relevant data for nonclinical and clinical studies to verity data integrity and to ensure work was performed according to protocols and complied with all relevant regulations.
• Provide quality oversight of contract or internal testing facilities to ensure adherence to all regulations, standard procedures and protocols. Alert the appropriate level of management with any non-compliance issues, ensure all corrective actions take place and elevate concerns when necessary.
• Support the development of agenda items for Early Development (EDD) team meetings to provide input and quality perspectives
• Provide input in the development of GLP related SOPs, and support cross-functional teams in the development of “Quality” related documentation (e.g., SOPs, training modules), and other documents as assigned.
• Communicate activities and feedback to core Quality management team to allow other team members to identify any issues or action items that need to be addressed.
• Contribute to GLP audits/inspections, and coordinate the review of responses to regulatory agency questions resulting from these inspections, and/or from external/internal audits.

Requirements

• Bachelor’s degree in biology, biochemistry, or the life sciences.
• Must be able to communicate effectively in English.
• A minimum of 3 years (for Sr. Manager) or 1 year (for Manager level) of related industry experience in Quality.
• 3 years of experience in working and/or overseeing GLP Quality in laboratories testing biologics.
• Experience performing audits of GLP testing labs is a plus.
• Experience with participation in and hosting regulatory audits is a plus.
• Experience working with CROs, vendors, and relationship management.
• Experience in auditing activities.
• Ability and desire to work well with diverse employees and customers in a cooperative and supportive manner.
• Must be a team player with good interpersonal skills, a forward thinker, always looking for pragmatic solutions that highlight ‘quality’ while being resource-efficient.
• Strong project management skills.
• Ability to articulate QA-GLP perspective and the status of QA-related activities at cross-functional meetings.
• Working knowledge of relevant FDA, ICH GCP guidelines, and GCP, GLP related regulations.
• Results driven with demonstrated successful outcomes.

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