Senior Manager, CSCQ, Qualified Person at Bristol-Myers Squibb

Dublin, County Dublin, Ireland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

University degree (science degree preferred)
Experience in team leadership
Knowledge of up to date GMP compliant Quality Management System implementation especially with clinical GMP requirements
Experience with investigation and incident management
Experience with audits and inspections
Knowledge of clinical pharmaceutical requirements
Experience in communicating with regulatory authorities

Responsibilities

Support start-up activities for Clinical Supply Chain Quality Dublin, including review and approval of QA related procedures, support preparation and approval of training materials, support review and approval of Quality Agreements, ensure knowledge transfer from current release site, support Manufacturer(s)/Importation Authorisation and Wholesale Distribution Authorisation submissions as required, and support regulatory inspections in the capacity of subject matter expert and host, as applicable
Support sustaining operations, including Quality Assurance preparation to support Qualified Person release of IMP’s, support Health Authority GMP/GDP inspections and audits across the supply chain, and support GCP HA inspections where required
Oversee/provide CSC Compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships
Oversee Site Master File maintenance
Oversee Manufacturer(s)/Importation Authorisation update and maintenance
Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products to business partners and senior management
Oversee QA activities including but not limited to: Use Date Extension, Generic Labelling activities, CoC generation, Israel release documentation
Review and approve procedural documents
Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
Proactively identify risk areas - brings ideas and strategies to the forefront and has a firm grasp of the business needs
Supervises QA Operations personnel (Manager, Senior Specialist) as assigned
Support OPEX programs and champion continuous quality improvement initiatives and other efficiency initiatives

Skills

Key technologies and capabilities for this role

Quality AssuranceSupply Chain ManagementGMPQuality AgreementsRisk ManagementLogisticsTraining MaterialsKnowledge TransferClinical Supply ChainISR StudiesIMP Supply

Questions & Answers

Common questions about this position

What is the employment type and duration for this role?

This is a full-time position on a 12 month fixed term contract.

Is this role remote or does it require working in a specific location?

This information is not specified in the job description.

What are the key responsibilities and skills needed for this position?

The role involves oversight of CSC Quality activities including logistics in EMEA/ASIA PAC, support for Clinical Supply Chain Quality Dublin start-up, QA procedures review, regulatory inspections, GMP/GDP audits, and quality issue management.

What is the company culture like at Bristol Myers Squibb?

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

What makes a strong candidate for this Senior Manager role?

Strong candidates will have expertise in CSC Quality oversight, experience with QA procedures, regulatory submissions, GMP/GDP inspections, and leadership in quality issue resolution within pharma supply chain.

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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