Manager - QA Investigation and CAPA

Description

The company develops innovative medicines for serious diseases, and this role sits within its quality team at the Summit Cell Therapy Facility.

This is a Monday to Friday role, 8 AM to 5 PM.

As Manager, QA Investigations, you will oversee quality and approve deviation assessments, investigations, and the related action and effectiveness check records.

You will provide quality oversight and assurance for manufactured products, keeping them compliant with applicable regulations, company policies, and guidelines.

Responsibilities

• Review and approve complex investigations, CAPAs, and effectiveness checks covering incoming materials, manufacturing, laboratory, facility, and utility systems.
• Write, review, and approve technical reports, such as risk assessments and deviation system monitoring reports, that support the deviation program.
• Confirm that corrective and preventive actions are robust and address the root cause.
• Lead the rollout of effective deviation processes across your site or function.
• Resolve problems with investigation processes or systems.
• Coach staff on deviations and investigations.
• Pass investigation issues to the global team and liaise with them on a regular basis.
• Champion a culture of quality within the deviation program.
• Monitor metrics and reprioritize work as needed to meet disposition timelines and other targets.
• Identify improvement opportunities and drive site or team continuous improvement goals and projects.
• Support internal and external inspections, and present individual topics during audits when needed.
• Support onboarding of newer team members.
• Act as subject matter expert on root cause analysis and investigations, guiding less experienced staff on atypical events.
• May perform routine reporting and analysis of metrics to keep quality events and actions closing on time.
• May lead meetings and represent the function at cross-functional and network meetings.
• Complete your assigned learning plan and help develop and deliver training for cross-functional teams.
• You may work as an individual contributor or as a people manager. As a people manager, you directly supervise staff who approve investigations and CAPAs.

Requirements

• Ability to research, interpret, and apply internal policies and regulatory guidance.
• Proficiency with digital tools such as MS Office and Smartsheets, and willingness to learn new software.
• Experience interpreting complex data, understanding multi-variable problems, and critically assessing and giving feedback on proposed CAPAs.
• Experience critically reviewing investigation reports and challenging technical conclusions against quality risk management principles.
• Strong verbal and technical writing skills, with the ability to present technical data to management clearly and accurately.
• Able to work in a fast-paced team and lead peers through shifting priorities.
• Strategic thinker who meets deadlines and supports work prioritization.
• Able to work independently across functions to make sure requirements are met.
• Able to motivate peers and build a positive team environment.
• Confident decision-maker who anticipates quality issues and solves problems proactively.
• Curious, critical thinker who develops innovative solutions.
• Bachelor's degree in a STEM field preferred. A high school diploma or associate degree with an equivalent mix of education and work experience may be considered.
• 6+ years in a regulated industry, preferably with 2+ years of deviation experience.
• Experience with FDA or EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Experience with electronic systems and databases.
• Proven skill with root cause analysis tools, including 5-WHY, IS/IS-NOT, human error prevention, Ishikawa (fishbone) diagrams, and process flow diagrams, among others.
• Apply even if you do not match every point on this list, as long as the role interests you.

Conditions

Location: Summit West, NJ, US. Full-time starting pay range: $93,910 to $113,794.

Full-time employees may also be eligible for discretionary incentive cash and stock.

Starting pay reflects the nature of the role, required skills, location, schedule, and your experience. Pay follows equity principles and employment law, and may change over time based on market factors and individual, team, or company performance.

The work model is based on the role's core responsibilities and is one of four: site-essential, site-by-design, field-based, or remote-by-design.

The company considers applicants with arrest and conviction records as local law requires and provides reasonable accommodations during recruitment.

Benefits

• Eligible employees can join comprehensive plans covering wellbeing support, retirement and financial protection, and medical, dental, vision, life, and disability insurance, subject to plan terms.
• U.S.-based exempt employees get Flexible Time Off with no fixed accrual limit, subject to manager approval, plus 11 paid company holidays a year.
• Non-exempt employees, RayzeBio employees, and employees in Puerto Rico receive 160 hours of paid vacation each year for new hires, subject to manager approval, plus 11 paid company holidays and 3 optional holidays.
• Depending on eligibility, you may get paid sick leave, up to two paid volunteer days a year, summer hours flexibility, and leave for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees also get an annual Global Shutdown from Christmas Day to New Year's Day.
• U.S.-based candidates can find full benefit details on the company careers site.