Director, External Manufacturing Quality, Cell Therapy at Bristol-Myers Squibb

Kariya-shi, Aichi, Japan

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Cell TherapyIndustries

Requirements

Expertise in Quality Assurance oversight for Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs) supporting cell therapy Drug Product (DP) production, testing, and disposition in Japan
Knowledge of GMP systems, regulatory compliance, and internal procedures for clinical and commercial cell therapy products
Experience with deviations, CAPAs, change controls, batch record review, lot disposition, and CoT/CoA generation
Ability to conduct annual risk assessments, routine/for-cause audits using quality and risk-based principles
Capability to partner cross-functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Cell Therapy Technical Operations (CTTO), Analytical Science & Technology (AS&T), Supply Chain (SC), and related teams
Proficiency in supporting CMO onboarding, including technology transfer, quality agreement generation, business process definition, and quality oversight framework
Skills in providing guidance on quality compliance and GMP requirements to CMC DP teams
Experience building and managing teams for drug product release and disposition
Ability to act as Quality Liaison with CMOs for BMS products, intermediates, and materials
Knowledge of transitioning CMO operations from clinical to commercial, including process validation, inspection readiness (GMP assessments, mock PLIs), and systems remediation
Availability for out-of-hours coverage and ensuring disposition within agreed turnaround times
Expertise in reviewing/approving CMO investigations, CAPAs, controlled documents, and acting as QA impact assessor for changes
Experience with data auditing, protocol/report review/approval for JNDA submissions
Ability to collaborate on quality systems, audit corrective actions, GMP audits, management reviews, KPI trending, and Material Review Board participation

Responsibilities

Provide Quality oversight of CMOs and CTLs for BMS cell therapy Drug Product manufactured in Japan, including routine QA responsibilities for production, testing, and disposition
Partner cross-functionally to ensure timely clinical and commercial release of Drug Product via deviations, CAPAs, change controls, batch record review, lot disposition, and CoT/CoA generation
Ensure CMO/CTL compliance through annual risk assessments and audits using quality/risk-based principles
Support BMS CMO onboarding process, including technology transfer, quality agreement generation, business process definition, and quality oversight framework
Provide guidance and direction to CMC DP team on quality compliance and GMP systems for externally manufactured products
Build and manage a team to support Drug Product release and disposition
Act as Quality Liaison with CMOs for BMS products, intermediates, critical starting, and raw materials
Support CMO transition from clinical to commercial production, including process validation, inspection readiness (GMP assessments, mock PLIs), and systems remediation
Perform batch record review and final DP disposition prior to Japan RP release; develop/manage team for disposition ensuring agreed turnaround times; provide out-of-hours coverage as required
Review and approve CMO investigations, CAPAs, and controlled documents
Act as QA impact assessor and approver for CMO-related changes
Conduct data auditing, review, and approval of protocols/reports for JNDA submissions
Collaborate with Quality Systems for timely CMO implementation of audit corrective actions
Assist in CMO GMP audits as required
Support Management Review activities and oversee trending of key quality, product, and GMP metrics for CMOs
Participate in Material Review Board meetings and evaluate product disposition recommendations
Partner with Technical Operations for run-the-business activities
Serve as BMS Quality Ops single point of contact, accountable for quality and compliance performance of assigned CMOs
Develop and monitor Key Performance Indicators (KPIs)

Skills

Quality Assurance

CMO Oversight

CTL Oversight

Deviations

CAPAs

Change Controls

Batch Record Review

Lot Disposition

CoT Generation

CoA Generation

Risk Assessments

GMP Compliance

Cell Therapy Manufacturing

Regulatory Compliance

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.

Land your dream remote job 3x faster with AI

Try Jobo Free