Manager, Quality Services, External Manufacturing at Bristol-Myers Squibb

Dublin, County Dublin, Ireland

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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

No explicit requirements listed in the job description

Responsibilities

Provide quality/compliance support to the Quality Operations
Co-ordinate/track the annual CMO Risk Assessment (RA), ensuring timely completion of the assessment
Support Quality Risk Mitigation Plans for CMOs based on the annual RA and any other interim triggers, and monitor their implementation
Write, revise and review GMP documentation where necessary
Prepare / negotiate Quality Agreements with the Third Party Manufacturers, Third Party Customers (TPCs), Alliance Partners and Marketing Authorisation Holders, including those associated with multiple CMOs / BMS parties
Support the Quality Operations metrics programs in relation to both Third Party and External Manufacturing performance
Support receipt of the Annual Product Quality Reviews (APQRs) from the Third Party Manufacturers and manage Quality Operations compliance with the APQR procedure
Work with BMS sites to ensure that APQRs are provided to TPCs and Alliance Partners in a timely manner
Support gap analysis of site SOPs / quality directives / policies / global Health Authority (HA) observations as the SME for Quality Operations and ensure gaps are mitigated
Where applicable lead/support the Quality Council activities
Provide general GMP / GDP HA inspection or Self Inspection support as required (preparation, back room, etc.)
Manage the quality oversight for TPCs / Alliance partners including change management, complaint management and investigation and CAPA management
Provide the requisite quality support to Global BMS functional groups such as Global Regulatory / CMC and the local country based regulatory managers in support of regulatory filings, product renewals, and regulatory agency questions etc. for CMOs
Represent ExM Quality on global quality teams/initiatives/projects

Skills

Quality Compliance

External Manufacturing

Contract Manufacturing Organizations

CMO Management

GMP

Supply Chain Management

Quality Assurance

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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