Sr. Manager, GLP - CQA

We need to output HTML fragment with sections: About the role (role overview), Responsibilities, Requirements, Benefits, Pay (maybe Schedule not present). Also maybe Skills? Not needed. Use

for each section heading. Use

• for lists. Use

  for prose. Do not repeat job title. Do not include Job ID etc. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove Work Authorization & Employment Eligibility, EEO Statement, privacy notice etc. Keep substantive info: company description? Might be considered "About the role"? Actually role overview is separate. The company description at top could be part of "About the role" or maybe not needed? The instruction: "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can include About the role (role overview). Responsibilities list. Requirements list. Benefits list. Pay (base pay range). Possibly also "Qualifications" but we have Requirements covering education/experience. We'll follow. We must not create sections with filler like "commensurate with experience". Pay range is given, so include Pay section. Benefits given, include Benefits. Schedule not present, so omit. We need to preserve all substantive information; do not invent or summarize away detail. So we need to include details from role overview, responsibilities, requirements, benefits, pay. We need to format as HTML fragment only. Let's extract: Company description: "Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma." That's company overview; could be part of About the role? Probably we can include as part of About the role paragraph. Role Overview: "The incumber will support the execution of GxP audit and inspection activities across GCP, GLP, GCLP and GVP, ensuring compliance with applicable global regulations and internal quality standards, while contributing to inspection readiness, SOPs development, and continuous quality improvement initiatives. The incumbent may be assigned to perform audits outside the U.S.A. (max 25% of the time)." We'll combine with company description maybe as About the role. Responsibilities: list many bullet points. Need to extract each bullet as

  . The responsibilities paragraph is a long sentence with many items separated by periods. We need to split into list items. Let's parse: "Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member, including internal processes, investigator sites, internal and external GLP study audits and general laboratory compliance audits vendors, and service providers" "Contribute to / coordinate regulatory inspection support activities (e.g., FDA, EMA, MHRA, and other Health Authorities), including preparation, coordination, and follow-up actions." "Support the risk-based audit program, including audit preparation, execution, reporting, and CAPA follow-up and tracking and effectiveness checks." "Document audit observations, assess responses, and review CAPA evidence for adequacy and timely closure." "Provide quality and compliance support to ensure clinical, non-clinical, and pharmacovigilance activities are conducted in accordance with GCP, GLP, and GVP requirements." "Support the development, maintenance, and periodic review of GxP SOPs, written standards, and QMS documentation." "Act as a CQA partner to the Clinical and Pre-clinical Functions to support the stakeholders by advising on compliance questions, issue resolution, and quality improvement actions." "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." "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." "Assist with quality metrics, trend analysis, and reporting to support identification of compliance risks and areas for improvement." "Support investigations of compliance issues, serious breaches, or quality events, escalating issues as appropriate." "Deliver training and coaching to business functions to promote GxP awareness and a strong quality culture." "Provide day-to-day support to applicable CQA functional line related to process improvements and harmonization with regulations." That's responsibilities. Requirements: list: "Bachelor’s degree in biology, biochemistry, or the life science." "Must be able to communicate effectively in English." "A minimum of 3 years of related industry experience in Quality in the Pharmaceutical industry." "3 years of experience in working and/or overseeing GCP, GVP and GLP Quality in laboratories testing biologics, as well as CROs." "Experience performing audits of GLP testing labs is a plus." "Experience with participation in and hosting regulatory audits." "Experience working with CROs, vendors, and relationship management." "Ability and desire to work well with diverse employees and customers in a cooperative and supportive manner." Also "Working knowledge of GCP, GLP, and GVP regulations and guidelines." etc from earlier "Skills" maybe. Actually after responsibilities there is a list: "Working knowledge of GCP, GLP, and GVP regulations and guidelines.Ability to support and perform audits using a risk-based approach.Good stakeholder management and communication skills.Ability to work independently on assigned tasks with appropriate supervision.Strong written, verbal, and documentation skills.Organized, detail-oriented, and able to manage multiple priorities.Willingness to travel domestically and internationally as required." These could be considered Skills or Requirements. We'll treat them as Requirements or maybe Skills. Since we have Requirements section, we can include these as bullet points as well. But we must not duplicate. We'll combine all requirement-like statements under Requirements. We also have "The incumbent will report to the Sr. Director of Clinical Quality Assurance, and dotted line to the GCP/GVP AD, and to the GLP Sr. Manager." That's reporting line; could be part of About the role or maybe not needed but it's substantive. We'll include in About the role paragraph. Benefits: list: "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." Also note: "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." That's also substantive; include maybe as a note. Pay: "Pay Range (Base Pay): : $146,410 USD - $192,164 USD". Also "Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles." We'll include Pay section with base pay range and mention performance-based bonus/equity. Schedule: not present, omit. Now produce HTML:

  About the role

  Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. The incumbent will support the execution of GxP audit and inspection activities across GCP, GLP, GCLP and GVP, ensuring compliance with applicable global regulations and internal quality standards, while contributing to inspection readiness, SOPs development, and continuous quality improvement initiatives. The incumbent may be assigned to perform audits outside the U.S.A. (max 25% of the time). The incumbent will report to the Sr. Director of Clinical Quality Assurance, and dotted line to the GCP/GVP AD, and to the GLP Sr. Manager.

  Responsibilities

  • Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member, including internal processes, investigator sites, internal and external GLP study audits and general laboratory compliance audits vendors, and service providers
  • Contribute to / coordinate regulatory inspection support activities (e.g., FDA, EMA, MHRA, and other Health Authorities), including preparation, coordination, and follow-up actions.
  • Support the risk-based audit program, including audit preparation, execution, reporting, and CAPA follow-up and tracking and effectiveness checks.
  • Document audit observations, assess responses, and review CAPA evidence for adequacy and timely closure.
  • Provide quality and compliance support to ensure clinical, non-clinical, and pharmacovigilance activities are conducted in accordance with GCP, GLP, and GVP requirements.
  • Support the development, maintenance, and periodic review of GxP SOPs, written standards, and QMS documentation.
  • Act as a CQA partner to the Clinical and Pre-clinical Functions to support the stakeholders by advising on compliance questions, issue resolution, and quality improvement actions.
  • 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.
  • Collaborate with the GL