Open to opportunities

Douglas Silber

@douglassilber

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Senior quality leader driving compliance, CAPA, and continuous improvement.

United States

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What I'm looking for

I seek senior quality leadership roles where I can build QMS, lead CAPA remediation, mentor teams, and drive compliance and continuous improvement in regulated life-science environments.

I am a senior quality and program management leader with 20+ years of experience building and leading global teams across life sciences and medical device organizations. I hold an MBA with a concentration in Human Resource Management and I specialize in Quality Management, CAPA systems, compliance to FDA/Health Canada/EMA, and process validation.

I have led quality organizations, implemented new QMS platforms, supervised large CAPA portfolios, and managed cross-functional remediation and regulatory inspection responses. I consistently deliver measurable improvements by deploying risk-based approaches, KPI-driven dashboards, and targeted training programs.

I am a collaborative leader who mentors teams, aligns stakeholders, and drives operational excellence—balancing strategic planning, budget management, and hands-on problem solving to improve product quality and customer outcomes.

Experience

Work history, roles, and key accomplishments

Current

Director of Quality

Current

Hill Dermaceuticals, Inc.

Jan 2025 - Present (1 year 1 month)

Lead all Quality functions including QA, QC, document control and compliance; implemented and maintained QMS aligned to FDA/Health Canada/EMA and cGMP, driving audit readiness and product release control for raw materials through finished goods.

Quality Management Regulatory Compliance QA&QC Audit Management CAPA Change Control KPI Analysis

Embedded Quality Lead

Amazon (through Sibylline)

Jan 2025 - Dec 2025 (11 months)

Developed and deployed a global quality coaching program and proactive quality mechanisms to identify negative customer experiences, enabling data-driven feedback loops and operational improvements.

Dashboarding Stakeholder Management Process Improvement Root Cause Analysis

QMS Manager / Senior Manager

Philips Respironics

Jan 2018 - Dec 2024 (6 years 11 months)

Managed 30+ global team members and led establishment of a new QMS, oversaw CAPA Review Board and KPIs, and supervised 300+ CAPA investigations to improve compliance and process effectiveness.

CAPA KPIs Team Leadership Risk Management

Manager, Quality and Regulatory

Abbott

Jan 2017 - Dec 2018 (1 year 11 months)

Managed quality and regulatory supervisors and specialists, served as Deputy Management Representative, led management reviews and KPIs, and drove continuous improvement including CAPA, SCAR and deviation management.

Regulatory Compliance CAPA Continuous Improvement Project Management Risk Assessment KPIs

Manager, Solutions Delivery

Zimmer Biomet (through MAETRICS)

Jan 2016 - Dec 2017 (1 year 11 months)

Hired and led over 120 positions across multiple projects, managed over $20M in concurrent projects and secured $11.7M+ in contracts within six months while driving remediation and root cause investigations.

Project Management Resource Management Contract Negotiation remediation Root Cause Analysis Budget Management

Principal CAPA/Compliance Specialist

Medtronic

Jan 2013 - Dec 2016 (3 years 11 months)

Served as CAPA/compliance SME and independent reviewer for multiple CAPA boards, led 25+ audits as lead auditor and developed RCA and CAPA training programs to strengthen effectiveness of corrective actions.

CAPA & Compliance Root Cause Analysis Training Development Effectiveness Checks

Corporate Quality Assurance Manager

LifeSouth Community Blood Centers

Jan 2012 - Dec 2012 (11 months)

Managed corporate quality assurance initiatives to ensure blood center compliance and quality standards across operations during tenure.

Quality Assurance & Compliance Auditing Document Control Risk Management

Quality Assurance Specialist

AxoGen Nerve Regeneration

Jan 2007 - Dec 2012 (5 years 11 months)

Performed quality assurance duties supporting manufacturing and compliance for nerve regeneration products, contributing to sustained quality systems and investigations.

Quality Assurance SOPs Documentation Auditing