QA Change Control Specialist III

Legend Biotech; Raritan (NJ); Sur place; USD 81 273 - 106 669; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Flexible spending and health savings accounts

Peer-to-peer recognition programs

Résumé du poste

A biotechnology company in New Jersey seeks a QA Change Control Specialist II responsible for quality oversight in a cell therapy manufacturing facility. Applicants should possess a Bachelor's degree in Science and a minimum of two years' experience within a cGMP environment. Strong communication, analytical problem-solving, and attention to detail are essential. This role offers a competitive salary, excellent benefits, and the chance to work within a collaborative team focused on cutting-edge therapies.

Qualifications

• Minimum of 2 years of relevant work experience in a cGMP manufacturing facility.
• GxP Quality System knowledge and relevant regulations (e.g., 21 CFR, ICH Q10).
• Experience in quality metrics reporting and process improvement techniques.

Responsabilités

• Support and streamline the site change control process.
• Manage change control activities throughout the lifecycle.
• Collaborate with functional departments to resolve issues.

Connaissances

Strong written and verbal communication skills

Analytical problem-solving

Attention to detail

Flexible and highly motivated

Formation

Bachelor’s Degree in Science or equivalent

Outils

Microsoft Office

Electronic quality systems

Description du poste

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world వైర, we apply these innovative technologies to discover safe, efficacious, and cutting‑edge therapeutics for منتصف patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines strengths and expertise to advance this immunotherapy in the treatment of multiple myeloma.

Position

QA Change Control Specialist II – Quality team, Raritan, NJ

Role Overview

The QA Specialist, Change Control role is an exempt level position with responsibilities for quality oversight of the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role manages change control activities throughout the lifecycle.

Key Responsibilities

• Support and streamline the site change control process.
• Participate in change control from initiation through completion.
• Schedule and participate in site change control review board meetings.
• Manage change control metrics reporting.
• Collaborate with functional departments to resolve issues.
• Support drafting of standard operating procedures.
• Support crossDistinct projects with many stakeholders.
• Participate in the training program for new members.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Review change controls, SOPs, and other documentation.
• Require minimal direction to complete tasks and consult with supervisor for decisions outside established processes.
• Driver continuous improvement.
• Have advanced computer skills to increase department productivity and broaden technical and scientific knowledge.
• Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Quality Control, and Operations Technical Support.

Requirements

• Minimum of a Bachelor’s Degree in Science, Information Science, or equivalent technical discipline.
• Minimum of 2 years of relevant work experience, preferably in a cGMP manufacturing facility, in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• GxP Quality лёSystem knowledge and relevant regulations (e.g., 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).
• Operational experience with electronic quality systems.
• Familiarity with core Quality Management System processes.
• Strong written and verbal communication skills, and analytical problem‑solving and conflict‑resolution skills.
• IT system lifecycle knowledge, including requirements gathering, change management, implementation, and continuous support.
• Flexible, highly motivated, with strong organization,Deletion, and attention to detail.
• Ability to manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic environment.
kazanFurthermore, effective interpersonal skills with ability to communicate across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Proficient knowledge of Microsoft Office.
• Experience in quality metrics reporting, analysis, and process improvement techniques.
• Proficiency with Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

Salary

The anticipated base pay range is: $81,273 USD – $106,669 USD.

Benefits

We offer a best‑in‑class benefits package, including medical, dental, and vision insurance; a 401(k) retirement plan with company match that vests fully on day one; equity and stock options for eligible employees; eight weeks of paid parental leave after three months of employment; and a paid time‑off policy that includes vacation days, personal days, sick time, 11 حوال belangen holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet and critical illness insurance, commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs. Please note: these benefits are offered exclusively to permanent employees; contract employees are not eligible.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex, gender identity or expression, sexual orientation, marital status, military service and veteran status, disability, or genetic information under applicable federal, state, or local laws.

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug‑free workplace.