BD
Medical Technology
Director,OperationsQuality
“Director, Operations Quality at BD. Skills: Quality Management System, Regulatory Compliance, Risk Management, Continuous Improvement. Define and execute site Quality Strategy. Influence risk-based decision-making”
Industry & Context.
Risk assessment; Quality issue assessment; Investigation; Root cause identification; Troubleshooting
~20% travel, Domestic travel, International travel, Sitting for long hours, Standing for long hours
What They're Looking For.
Must Have
Quality Strategy definition and execution, Quality Management System establishment and maintenance, GMP compliance assurance, Product release approval, Laboratory controls and testing strategies, QMS elements execution, Investigation and CAPA implementation, Data integrity principles (ALCOA+), Regulatory inspection leadership, Process robustness and validation, Risk assessments for product quality, Critical quality issue escalation
Nice to Have
Bilingual (English/Spanish) preferred
What You'll Do.
Define and execute site Quality Strategy
Influence risk-based decision-making
Promote accountability and transparency
Lead and coach Quality organization
Ensure capability building
Plan succession planning
Liaise with global Infection Prevention team
Liaise with marketing/sales
Ensure Pharmaceutical Quality requirements are known
Control suppliers for quality
Provide project support
Partner with regional representatives
Drive continuous proactive engagement
Collaborate with R&D for product transfer
Manage inspection readiness programs
Assess quality issues
Determine impact in the field
Address quality issues timely
Secure GMP certification
Establish and maintain Quality Management System
Ensure manufacturing facility compliance
Ensure analytical laboratory compliance
Ensure warehouse compliance
Ensure distribution compliance
Ensure GMP compliance of products
Define manufacturing quality standards
Establish testing methods and procedures
Support manufacturing requirements
Support engineering requirements
Improve design for manufacturability
Approve batch disposition
Ensure appropriate laboratory controls
Ensure specifications are scientifically sound
Ensure testing strategies are compliant
Assume global responsibility for personnel communication
Provide support for quality documents
Manage product quality reports
Manage process quality reports
Analyze information and trends
Coordinate internal audits
Facilitate internal audits
Coordinate external audits
Facilitate external audits
Support Health Authority inspections
Execute response efforts for inspections
Manage QMS elements execution
Manage change control
Manage complaint investigations
Manage out of specification investigations
Manage out of trend investigations
Manage non-conformances
Manage training compliance
Comply with Business Unit policies
Comply with Corporate policies
Ensure root cause identification
Implement effective CAPA
Ensure data integrity principles are embedded
Ensure continuous compliance with FDA
Ensure continuous compliance with EMA
Ensure continuous compliance with global health authorities
Lead regulatory inspections
Ensure high-quality responses to observations
Ensure timely responses to observations
Maintain site in inspection readiness
Act as primary Quality interface with regulatory authorities
Partner with Manufacturing
Partner with Engineering
Ensure process robustness
Ensure validation lifecycle compliance
Support technology transfers
Support new product introductions
Drive continuous improvement initiatives
Lead risk assessments related to product quality
Lead risk assessments related to patient safety
Conduct field impact evaluations
Make recall decisions
Conduct health hazard assessments
Ensure timely escalation of critical quality issues
Ensure management of critical quality issues
How You'll Work.
Team & Collaboration
Site leadership team; Global business objectives; Global Infection Prevention team; Internal customers; Regional representatives; Manufacturing; Engineering; R&D
Communication Scope
Written communication; Verbal communication
Process & Methodology
Change control, CAPA, Investigations, New product introductions
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