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Manager / Sr Manager of GLP-CQA
2 months ago
Legend Biotech US is seeking a highly skilled Quality Assurance Manager / Sr Manager of GLP-CQA to join our Regulatory team based in Somerset, NJ. The successful candidate will be responsible for ensuring compliance with GLP regulations and Health Authorities' guidance/principles.
Key Responsibilities- Develop and maintain a compliant quality system to meet GLP regulations and Health Authorities' guidance/principles.
- Oversee the overall GLP quality oversight of studies, from assessment of external vendors via audits to their onboarding.
- Review and/or support the development of SOPs and supporting the bioanalytical assays required for GLP or CGLP studies.
- Partner with study teams to maintain and/or reinforce a 'quality culture' and contribute to Legend Biotech's inspection-readiness goal.
- 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 GLP's relevant functions in reviewing relevant data for nonclinical and clinical studies to verify data integrity and 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.
- 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.
- Education: 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.
- Additional Language Requirements: not required, but Chinese language would be considered a plus.
