Director Quality & Regulatory Affairs COE

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Director, Q&RA COE 

Position Summary: OPS.QAOP.M09 
Cost Center Info: 



Build, scale, and lead a Q&RA Center of Excellence (COE) that uplifts compliance, reduces risk, and accelerates submissions/market access with targeted scaling for Corporate and Specialty Diagnostics Group (SDG). In partnership with the Vice President, Global Q&RA, lead the strategy, operating model, and execution of Q&RA COE from inception to scale in coordination with business objectives and Q&RA strategy. Standardizing processes, enable digital tools, and deliver measurable improvements in audit readiness, product registrations and time-to-approval. 
Key Responsibilities: 
COE Build-up and Operating Strategy 

In coordination with corporate and businesses, define the multi-year Q&RA COE strategy, service catalog (QA, RA, Digital), and success metrics aligned to BU roadmaps (Devices, IVDs etc.). 
Architect the operating model (org design, spans, skill ladders, intake→ delivery→ release→ post-market loops). 
Establish governance - Quality Council, Submission Board, Risk & Compliance forum, and quarterly Management Review inputs for COE to support 
Execute strategic plans according to agreed and established timelines for Group and Corporate functions. 

COE Organization Structure Planning 

Build Stand up core functional units for main pillars within Q&RA (QA, RA, CSV.CSA/Digital/analytics) and define the organization structure as per the global business requirements. 
Define career architecture for the teams and competency rubrics along with implementing a COE Academy for onboarding/certification. 
Hire, mentor, develop manager readiness and career pathways (role-based roadmaps, transparent criteria) for all the roles. 
Maintain healthy engagement (by employee engagement programs, certification sponsorships) and retention with succession plans for all critical roles. 


Compliance and Regulatory Affairs Excellence (Global Markets) 

Ensure robust ISO 13485 / 21 CFR 820 (QMSR) execution by maintaining policy/SOP hierarchy and change control. 
Run internal audit program and mock inspections for audit readiness and assessing areas of improvement. 
Oversee the teams working on Quality, product registrations (dossier authoring and publishing) across globe and ensure timely delivery with quality by aligning with right teams and resources. 
Govern different metrices around Quality parameters (CAPAs, deviations, RIM hygiene, HA query management, change significance determinations, and labeling/claims & UDI master data. 



Digital and Analytics Enablement for Quality ecosystem 

Scale automation and analytics programs for the stakeholders. 
Build a Digital quality ecosystem, integrating different systems for efficient data flow with compliance and data integrity, for improvising operational excellence. 
Brainstorm, build and govern creations of varied digital dashboards for quick analysis of data and decision making. 

Stakeholder and Vendor Management 

Partner with division/business leads within Thermo Fisher for strategic workforce planning in Q&RACOE. 
Build a multi-vendor and varied engagement sourcing strategy with outcome-based SOWs, SLAs, rate cards, and surge capacity for peak loads. 
Create a comprehensive governance program for vendor managed resources and their conversions (in C2H engagement model). 
Run-steering meetings with relevant stakeholders to ensure smooth talent hiring/sourcing, performance reviews, process improvements and employee retention. 
Represent Q&RA in executive forums, brief leadership on risk posture and readiness. 

Governance 

Own and plan on Q&RA COE budget, forecasting, hiring ramp, KPIs, performance metrices and digital enablement programs in alignment with Vice President, Global Quality & Regulatory Affairs 
Publish and discuss relevant KPI dashboards in management forums/meetings and produce data for QMR in alignment with business cadence 
Drive continuous improvement plans with quantified benefits. 


Required Qualifications 

15+ years in Quality and Regulatory Affairs within medical devices/IVD (strongly preferred), life sciences, or combination products. 
Proven leadership of ISO 13485/21 CFR 820 QMS, audits/inspections, and global product registrations. 
Demonstrated success in building Q&RA teams (200+), engaging with internal/external stakeholders/vendors and history of regulatory bodies interactions and inspection management. 
Deep knowledge of risk management (ISO 14971), design control, process validation, complaint handling/CAPA, and post-market surveillance. 
Bachelor’s/Master’s in Engineering, Life Sciences, Pharmacy, or related; RAC, ASQ CQE/CQA, Lead Auditor (ISO 13485), or Six Sigma preferred. 
Competencies expected, 
Strategic and systems thinking with risk-based decision-making. 
Inspection-grade communication and storytelling to regulators/executives. 
Vendor negotiation and outcome-based contracting. 
People leadership – mentor and build leaders with culture of “audit-ready always.” 
Building a culture of continuous improvement with a focus on velocity, intensity and innovation.