Sr. Manager, Quality Assurance for Quality Control

Bristol Myers Squibb • Indianapolis, IN

6d • Onsite

About The Position

The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the RayzeBio facility in Indianapolis in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Manager provides Quality support and oversight for QC laboratory operations such as sample management, testing, and data review, method development, validation, and transfer, equipment validation, and associated projects. The Senior Manager supports thorough review and approval of QC investigations, change control records, Standard Operating Procedures, Method validation and transfer documents, and technical protocols, and assists in preparing for regulatory audits.

Requirements

• Bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 10+ years relevant work experience (analytical development, Quality Control, and/or Quality Assurance), preferably in a regulated environment is required.
• Quality Assurance experience would be considered beneficial. An equivalent combination of education and experience may substitute.
• Knowledge of analytical method lifecycle including development, validation, and transfer
• Practical understanding of common QC procedures, techniques, and laboratory equipment/instrumentation and the application and interpretation of most-relevant GMP concepts and compendia requirements (e.g. US FDA, CFR, USP, EP, JP)
• Knowledge of Microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin.
• Knowledge of common QC and environmental monitoring procedures and techniques.
• Equivalent combination of education and experience acceptable.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of Clinical and commercial Quality laboratory operations.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills

Responsibilities

• Quality Assurance support and oversight of QC (Analytical and Microbiological) laboratory operations including laboratory investigations, deviations, corrective or preventative actions, method development, validation, and transfer activities, equipment validation work and associated projects.
• Quality Assurance support of QC associated with the manufacturing process including QC activity related to in process and release product testing, raw material testing, and environmental monitoring activities.
• Assesses QC driven change controls and supports completion of any associated change actions.
• Participates in ongoing laboratory operations/continuous improvement and risk management projects.
• Participates in risk assessments related to QC laboratory operations.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Participates as requested in the response team for audits and inspections by health authorities.
• Conducts regular walkthroughs of QC laboratories.
• Performs review and approval of Quality, Laboratory, and Analytical Standard Operating Procedures (SOPs) and documents.
• Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees