Senior Specialist, Quality Risk Management

About the role

The Senior Specialist, Quality Risk Management supports the implementation of the Quality Risk Management (QRM) program, system, and tools. They interact cross-functionally across the ImmunityBio organization.

Responsibilities

• Supports the implementation of the Quality Risk Management (QRM) program, system, and tools through the development and/or creation of procedures, work instructions, education and training materials, etc.
• Delivers training and coaching on QRM principles, tools, and best practices.
• Tracks QRM program records and deliverables.
• Participates on electronic system validation projects, establishing and/or reviewing electronic system validation documentation and performing verification/validation/qualification testing related to system changes, as needed.
• Prepares and presents data and reports as well as meeting minutes associated with QRM metrics, as required.
• Provides and may execute suggested remediation activities.
• Promotes risk-based approaches to daily operations and strategic initiatives.
• Supports leading and facilitating risk assessments as requested by stakeholders.
• Identifies and provides leadership for continuous improvement initiatives for ImmunityBio related to QRM.
• Provides support and participates as the Subject Matter Expert for the QRM program during audits and inspections.
• Maintains and completes Quality Systems records and Quality Documentation Records in a timely manner, as assigned.
• Cross-trains on other Quality & Regulatory Compliance and Supplier Quality programs as assigned.
• Performs other quality related duties as assigned, including but not limited to participating in cross-functional team meetings to resolve non-conformance and CAPA issues and performing activities related to change controls.

Requirements

• Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7+ years of experience in a GMP-regulated Biologics or Pharmaceutical environment required.
• 5+ years’ experience in clinical and commercial regulations and guidance documents, including 21 CFR 210/211, 1271, 810 and 2001/83/EC, 2006/17/EC, 2006/86/EC, ISO, ICH, and PIC/S required.
• Experience in the use of Risk Management tools including but not limited to FMEA, Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Hazard Operability Analysis (HAZOP), Risk Ranking, and other supporting statistical tools required.
• Experience in preparing for regulatory authority inspections, including direct interaction with inspectors preferred.
• Experience in a clinical and/or commercial phase pharmaceutical environment preferred.
• American Society of Quality Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt Certification preferred.

Qualifications

• Able to prepare written communications with clarity and accuracy.
• Must have strong authorship and be able to critically review responses and partner on corrective actions/commitments consistent with quality and regulatory compliance expectations.
• Demonstrated ability to interface with senior leaders and cross-functional teams.
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills with a strong sense of personal accountability for work tasks.
• Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
• Demonstrated ability to be detail oriented, while managing multiple projects simultaneously.
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, and project timelines.
• Must be proficient in Microsoft Office (Excel, Word, OneNote, PowerPoint, Visio, SharePoint) and Adobe Professional software.
• Perform work that consistently requires independent decision-making and the exercise of independent judgment and discretion.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day