Senior Manager, Quality Assurance - Lab Operations at Bristol-Myers Squibb

Devens, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s or Master’s degree in Life Sciences, Chemistry, or a related field
8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment
3+ years of leadership or management experience
Strong understanding of analytical testing, method validation, and stability programs for biologics
In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles
Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare)
Strong leadership, communication, and interpersonal skills
Ability to manage multiple priorities in a fast-paced environment
Experience supporting regulatory inspections (FDA, EMA, etc.)

Responsibilities

Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies
Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data
Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations
Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions
Manage and mentor a team of QA professionals supporting lab operations
Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents
Participate in internal audits and regulatory inspections as a QA representative and subject matter expert
Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture

Skills

Key technologies and capabilities for this role

GMPcGMPGLPQA OversightMethod ValidationStability StudiesData IntegrityQC TestingRegulatory ComplianceLaboratory Documentation

Questions & Answers

Common questions about this position

What qualifications and experience are required for this role?

Candidates need a Bachelor’s or Master’s degree in Life Sciences, Chemistry, or a related field, 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment, and 3+ years of leadership or management experience.

What key skills are needed for the Senior Manager, Quality Assurance - Lab Operations position?

Required skills include experience with electronic laboratory systems like LIMS, Empower, LabWare, strong leadership, communication, and interpersonal skills, ability to manage multiple priorities in a fast-paced environment, and experience supporting regulatory inspections.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or what is the work arrangement?

This information is not specified in the job description.

What does the company culture look like at Bristol Myers Squibb?

The culture emphasizes challenging, meaningful, life-changing work in a flexible environment with high-achieving teams, opportunities for growth, and a focus on work-life balance through competitive benefits.

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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