Manager - QA Investigation and CAPA

Duties/Responsibilities

• Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
• Ensure the corrective/ preventive actions are robust and adequately address the root cause.
• May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
• Drive implementation of effective deviation processes within representative site/function.
• Coach employees on aspects of deviations/investigations.
• Resolve investigational process or system issues.
• Ensure investigation issues are cascaded to global team and liaise with global team on routine basis.
• Champion for culture of quality within the deviation program.
• Support monitoring metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.
• Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.
• Support internal and external inspections as required.
• May present individual topics during audits as needed.
• Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
• Support integration of newer team members.
• Acts as Subject Matter Expert of the root cause analysis and investigations process and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.
• May lead meetings and represent function at cross functional and network meetings.
• May be an Individual Contributor or People Manager.
• As people manager, provide direct supervision of personnel approving investigations and CAPA.

Qualifications

Specific Knowledge, Skills, Abilities

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
• Demonstrated experience to interpret complex data & results, understand significant problems with multiple variables and critically assess and provide feedback on proposed CAPA.
• Demonstrated experience to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Ability to think strategically, meet deadlines and support work prioritization.
• Able to independently work across functional groups and teams to ensure requirements are met.
• Ability to motivate and foster a positive team environment.
• Confident in making decisions, able to anticipate Quality issues and proactively solve problems.
• Curious and ability to think critically to create innovative solutions.

Education/Experience/ Licenses/Certifications

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 6+ years of experience in a regulated industry, preferably with 2+ year of deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic system and databases.
• Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, IS/IS-NOT, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Summit West - NJ - US $93,910 - $113,794

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https //careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https //careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/

For roles based in Washington State only If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.comwith the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1608081 Manager - QA Investigation and CAPA