When People Connect In Person
Medical Technology
Sr.Director,OperationsQualityManagement
Neural analysis suggests this role is
optimal for Director candidates.
“Sr. Director, Operations Quality Management at When People Connect In Person. Skills: Operations Quality Management, Quality Management System, Regulatory Compliance. Oversee all Quality functions at the site. Ensure compliance with regulatory requirements”
What You'll Achieve.
Restore and maintain compliance; Ensure consistent delivery of products; Ensure inspection ready state; Address quality issues in timely manner; Proactive driving improvements
Industry & Context.
Decision-making under pressure; Root cause analysis
~20% travel, Sitting for long hours, Standing for long hours
What They're Looking For.
Must Have
21 CFR Parts 210, 211, 820 compliance, EU ICH guidelines compliance, Internal global standards compliance, Good Manufacturing Practices compliance, Site Quality Head, Management Representative
Nice to Have
Bilingual (English/Spanish) preferred
What You'll Do.
Oversee all Quality functions at the site
Ensure compliance with regulatory requirements
Ensure compliance with internal global standards
Provide strategic leadership for QMS
Ensure consistent delivery of safe products
Ensure consistent delivery of effective products
Ensure consistent delivery of compliant products
Serve as site Quality Head
Serve as Management Representative
Lead remediation situations
Manage response strategy
Govern cross-functional remediation
Manage health authority commitments
Execute to restore compliance
Execute to maintain compliance
Define site Quality Strategy
Execute site Quality Strategy
Align strategy with global objectives
Align strategy with regulatory expectations
Influence risk-based decision-making
Influence operational excellence
Foster a quality culture
Promote accountability
Promote continuous improvement
Lead the Quality organization
Coach the Quality organization
Develop the Quality organization
Ensure capability building
Ensure succession planning
Liaise with global Infection Prevention team
Liaise with marketing/sales organization
Liaise with other internal customers
Ensure Pharma Quality requirements are known
Ensure Pharma Quality requirements are controlled
Ensure Pharma quality requirements are implemented
Provide project support
Partner with regional representatives
Drive proactive engagement of QA team
Collaborate with R&D department
Transfer new design engineering products
Manage inspection of readiness programs
Manage inspection of readiness activities
Assess quality issues
Determine impact in the field
Ensure quality issues are addressed
Engage with appropriate teams
Secure GMP certification of the site
Secure GMP certification of critical suppliers
Ensure active engagement in pharmacovigilance
Ensure participation in pharmacovigilance
Ensure partnership in pharmacovigilance
Ensure active engagement in OUS quality
Ensure participation in OUS quality
Ensure partnership in OUS quality
Establish Quality Management System
Maintain Quality Management System
Ensure manufacturing facility compliance
Ensure analytical laboratory compliance
Ensure warehouse compliance
Ensure distribution compliance
Ensure functional areas compliance
Ensure GMP compliance of products
Define manufacturing quality standards
Establish appropriate testing methods
Establish appropriate testing procedures
Establish manufacturing requirements
Support manufacturing requirements
Establish engineering requirements
Support engineering requirements
Improve design for manufacturability
Ensure products meet identity requirements
Ensure products meet strength requirements
Ensure products meet quality requirements
Ensure products meet purity requirements
Provide final Quality approval for batch disposition
Ensure appropriate laboratory controls
Ensure specifications are scientifically sound
Ensure specifications are compliant
Ensure testing strategies are scientifically sound
Ensure testing strategies are compliant
Assume global responsibility for Qualified Personnel communication
Provide support to global organizations
Support preparation of quality documents
Manage product quality reports
Manage process quality reports
Summarize information and trends
Coordinate internal audits
Facilitate internal audits
Coordinate external audits
Facilitate external audits
Provide leading role support during inspections
Ensure response efforts are executed
Manage timely execution of QMS elements
Manage robust execution of QMS elements
How You'll Work.
Team & Collaboration
Site leadership team; Global Infection Prevention team; Marketing/sales organization; R&D; Internal customers; Regional representatives; Appropriate teams
Communication Scope
Effective communication; Written communication; Verbal communication
Process & Methodology
Change control, CAPA, Complaint investigations, Out of specification investigations, Out of trend investigations, Non-conformances
Full Job Description
**We are the people who give possibilities purpose** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. # Job Description **We are the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker** **of possible **with us. **Job Summary:** The Sr. Director of Operations Quality Management is responsible for leading and overseeing all Quality functions at the site, ensuring full compliance with applicable regulatory requirements (e.g., 21 CFR Parts 210, 211, 820; EU GMP; ICH guidelines) and internal global standards for the El Paso, TX Site. This role provides strategic leadership for the Quality Management System (QMS), ensuring consistent delivery of safe, effective, and compliant products. The position serves as the site Quality Head and Management Representative, with accountability for product quality, regulatory compliance, inspection of readiness, and continuous improvement of quality systems and processes. Lead and manage warning letter and broader regulatory remediation situations, including response strategy, cross-functional remediation g
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