Senior Manager - QA for QC at Bristol-Myers Squibb

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

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)

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

Skills

Key technologies and capabilities for this role

cGMPQuality AssuranceQuality ControlAnalytical TestingMicrobiologyMethod DevelopmentMethod ValidationEquipment ValidationSample ManagementData ReviewLaboratory Operations

Questions & Answers

Common questions about this position

What is the salary for the Senior Manager - QA for QC position?

This information is not specified in the job description.

Is this a remote position, or where is it located?

This information is not specified in the job description.

What are the key responsibilities or skills needed for this role?

The role requires providing quality oversight for QC Analytical and Microbiology laboratory operations, supporting sample management, testing, data review, method development, validation, transfer, equipment validation, investigations, change controls, SOPs, and preparing for regulatory audits in accordance with cGMP.

What is the company culture like at Bristol Myers Squibb and RayzeBio?

The culture is described as challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow and thrive alongside high-achieving teams, and a focus on balance and flexibility. They offer competitive benefits and recognize the importance of resources for work and personal goals. RayzeBio is a dynamic biotechnology company focused on improving cancer survival through targeted radioisotopes.

What makes a strong candidate for this Senior Manager role?

A strong candidate would have expertise in quality assurance oversight for QC laboratory operations, including analytical and microbiological testing, cGMP compliance, method validation, investigations, change controls, and regulatory audit preparation, ideally with experience at a facility like RayzeBio in Indianapolis.

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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