Sr. CQV SpecialistRole OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effectivencommunication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.
Key Responsibilities- Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.
- Manages multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
- Supports and/or owns technical and quality investigations, CAPAs and corrections
- Develops and performs any required remediation efforts and associated CAPA plans.
- Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
- Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
- Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.
- Train and support the junior team members on different CQV activities.
- Present CQV work to regulatory and internal audit teams.
- Other responsibilities as assigned.
- Making decision on corrective action in deviation events.
- Make decisions on technical approach, methodology per applicable procedure.
- Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.
Requirements- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
- A minimum of 7 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
- Ability to use following or similar systems for business needs Microsoft suite ERP systems: Maximo, Siemens EMS, Comet, Kneat Testing system: Kaye AVS, Kaye Valprobe.
- 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. • Ability to quickly process complex information and often make critical decisions with limited information.
- Proficient in applying process excellence tools and methodologies. • Ability to independently be responsible for a portfolio of ongoing projects.
- Ability to pay attention to details and follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- 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.
- Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
- Language(s): English
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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):
$110,706-$145,303 USD
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. 
