Manager, BI&T Computer Software Validation (CSV) at Bristol-Myers Squibb

Leiden, South Holland, Netherlands

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor’s in engineering, IT, Science field or equivalent
Minimum 5+ years’ relevant industry experience (prior Cell Therapy experience highly valued but not required)
Demonstrated experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment
Understanding of, and experience with, supply chain, manufacturing and quality domains and supporting technology including Manufacturing systems (MES), Quality systems (LIMS, QMS), Supply chain systems (ERP), Process Automation, Historians and Benchtop systems in QC and MFG
Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP
Knowledge of industry standard Quality and Compliance methodology to ensure IT systems deliver intended performance and meet regulatory requirements
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 and good documentation practices
Demonstrated success working in a high-performing, business results-driven environment

Responsibilities

Drafting and reviewing validation protocols, including validation masterplans, design documents, process and instrumentation drawings, IQ, OQ, and related protocols
Complete understanding of BMS policies and procedures for computer software validation
Close collaboration with cross-functional subject matter experts to develop and implement validation methodologies for IT systems at the Leiden site
Actively participate with other groups to analyze and address process deficiencies, working collaboratively with peers across departments and quality teams
As a validation subject matter expert in the BI&T department, contribute to multi-functional teams, advise personnel on validation matters, and defend validation work before regulatory agencies and auditors
Provide expertise and guidance to management, peers, and junior professionals
Responsible for compliance with local and global SOPs during qualifications
Compliance with (Project) Change Management Procedure and Change Management drafting, review and approval
Audit and Operational readiness for the site
Change Management during qualification and sustaining
Other duties as assigned by Senior Manager, BI&T Quality and Compliance

Skills

Key technologies and capabilities for this role

Computer Software ValidationCSVValidation ProtocolsIQOQValidation MasterplansP&IDIT Systems ValidationGAMPRegulatory Compliance

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Manager, BI&T CSV role?

A Bachelor’s degree in engineering, IT, Science field or equivalent is required, along with a minimum of 5+ years of relevant industry experience. Prior Cell Therapy experience is highly valued but not required, and demonstrated experience with IT Quality & Compliance applications in a bio-tech manufacturing environment is essential.

What is the location for this Manager, BI&T CSV position?

The role is based at the Leiden site.

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

The culture is described as challenging, meaningful, and life-changing, with uniquely interesting work, opportunities to grow alongside high-achieving teams, and a focus on work-life balance and flexibility.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What experience makes a candidate stand out for this CSV Manager position?

Candidates with prior Cell Therapy experience and demonstrated expertise in IT Quality & Compliance systems, along with knowledge of supply chain, manufacturing, and quality domains in biotech, will stand out.

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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