Sr Director, Corporate Quality, Regulatory & Product Compliance
Role Description
The Senior Director, Corporate Quality, Regulatory & Product Compliance owns global Regulatory, Safety, Compliance, and Product/Service Life Cycle Management (PLCM) including the Quality Management System, and the product gating process across the enterprise. This leader ensures the delivery of safe, compliant, reliable, and high‑quality products, while enabling scalable, data‑driven operations through modern digital and AI‑enabled quality systems.
This role leads enterprise frameworks for regulatory compliance, product safety engineering, ISO/QMS, and PLCM governance, and drives the adoption of advanced analytics, automation, and AI to proactively manage risk, accelerate time‑to‑market, and improve operational predictability.
What you will do
Enterprise Regulatory & Compliance Governance
· Own and evolve the global regulatory compliance strategy across all regions and product lines.
· Leverage AI‑enabled regulatory intelligence tools to monitor regulatory changes and assess product impact.
· Ensure compliance with UL, FCC, CE, RoHS, REACH, Prop 65, and other applicable standards.
· Lead regulatory audits, certifications, and technical submissions using digitized compliance evidence systems.
· Embed compliance requirements early in product architecture through close partnership with Engineering and Product teams.
Product Safety & Risk Leadership
· Lead the corporate product safety program, including hazard analysis, FMEA, risk mitigation, and field actions.
· Deploy data‑driven and AI‑assisted risk assessment methods to identify emerging safety issues.
· Oversee investigations, RCA, and CAPA using advanced analytics across field, manufacturing, and reliability data.
· Establish predictive safety metrics and dashboards for executive review.
ISO, QMS & Digital Quality Systems
· Own enterprise ISO frameworks (ISO 9001, 14001, 45001, etc.).
· Lead the transformation toward a digital, AI‑enabled QMS, including:
o Intelligent document control
o Continuous audit readiness
o Process mining and compliance monitoring
· Partner with global functions and manufacturing partners to ensure consistent QMS execution.
Product / Service Life Cycle Management (PLCM)
· Own and govern the enterprise PLCM framework and stage‑gate process.
· Implement AI‑driven launch readiness and risk scoring across NPI programs.
· Provide executive visibility through integrated dashboards, predictive KPIs, and automated gate reviews.
· Act as Secretary of the PLCM Steering Committee.
Cross‑Functional Leadership & Culture
· Champion a quality‑first, data‑driven, and AI‑augmented culture across Engineering, Operations, Supply Chain, and Service.
· Drive KPI governance using advanced analytics and trend‑based insights.
· Influence senior leaders through clear, evidence‑based recommendations.
What you should have
· 10 + years of experience in Quality, Regulatory, Product Safety, PLCM, or NPI in a hardware or regulated industry.
· Proven experience scaling global quality and compliance programs.
· Strong understanding of digital QMS, analytics, and AI applications in quality and operations.
· Experience engaging engineering‑led organizations and executive leadership.
· Experience managing contract manufacturers globally.
Preferred
· Advanced degree in Engineering, Quality, Operations, or Regulatory Affairs.
· Experience implementing AI, automation, or advanced analytics in quality, compliance, or operations.
· Lean, Six Sigma, DFx, or reliability engineering expertise.
Leadership Competencies
· Cross‑functional influence and change leadership
· Systems thinking with a digital and AI mindset
· Data‑driven and predictive decision making
· Strong balance of technical depth and executive communication.
Travel
You are required to travel as necessary.
Pay & Benefits
For this role, the estimated base salary range is between CAD 180,000 - CAD 250,000. The actual base salary will vary based on various factors, including market, location, and individual qualifications objectively assessed during the interview process. This position may also be eligible to receive incentive compensation: bonus, equity, and benefits. Sales positions are generally offered a competitive On Target Earnings (OTE) incentive compensation structure.
Diversity, Equality, and Inclusion at Harmonic Inc
At Harmonic, we believe that building and nurturing a global team with diverse backgrounds and voices is critical to our success. Together, we achieve excellence through creativity and innovation, build relationships based on integrity and mutual respect, and deliver the highest quality in every aspect of our business for the benefit of our employees, business partners and shareholders.
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