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Ron R

@ronr

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Senior GxP quality and compliance leader who builds scalable regulatory-ready operating systems.

Canada

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What I'm looking for

I’m looking for a Director-level role where I can lead global GxP quality and compliance, build scalable QMS/eQMS and operating systems, and deliver executive-ready visibility through KPIs, audits, and risk-based continuous improvement.

I am a senior GxP Quality (QA-OPS) professional with 25+ years of experience leading end-to-end operations, supply execution, and operating systems across highly regulated industries, including Pharmaceutical, Biotech, Medical Device, and Food manufacturing. I scale quality operations and compliance, stabilize supply, and embed compliant, efficient execution across manufacturing, supply chain, quality, and regulatory environments.

Over a decade in enterprise and global leadership roles, I drive operational readiness, regulatory and Quality compliance, governance models, performance management, cost of quality, and risk mitigation. I’m known for translating complex regulatory and technical requirements into practical operating models that enable reliable delivery, speed-to-market, and sustainable growth—while building disciplined execution cultures.

I lead Quality Operations and Compliance as a primary global quality liaison, overseeing GMP manufacturing compliance, inspection preparedness, and adherence to GMP, medical device regulations, ISO standards, SOPs, and corporate policies. I implement performance metrics, KPIs, and executive dashboards, lead gap analyses and audits (including Health Canada and FDA requirements), and strengthen QMS through electronic systems (eQMS), data integrity, validation/computer validation, and risk-based CAPA and improvement programs.

Experience

Work history, roles, and key accomplishments

Current

Lead Global GxP Consultant

Current

Consulting

Sep 2015 - Present (10 years 9 months)

Led global GxP quality consulting for regulated manufacturing and clinical programs, applying GMP/ISO and auditing approaches to support timely execution and regulatory-ready documentation. Delivered deviation investigations, batch document review, Cost of Quality (COQ), equipment and computer validations (including data integrity), and regulatory dossier preparation across pharma, biologics, NHPs

GxP Quality GMP Compliance ISO 9001 ISO 13485 ISO 14001 Quality Audits CAPA Data Integrity

Director GxP QA, Compliance & Regulatory

SRx Health Solutions Inc.

Oct 2023 - Sep 2025 (1 year 11 months)

Directed GxP QA, compliance, and regulatory activities to ensure adherence to GCP/cGMP and ISO 13485-based quality systems, including internal and external audit support and risk-based remediation. Developed and maintained global device & drug quality procedures, oversaw supplier qualification for CRO/CDMO partners, hosted regulatory inspections, and supported eQMS implementation and regulatory do

GCP ISO 13485 External Audits Inspections QMSR SOR 98 282

Global Head of QA & Compliance

Eupraxia Pharmaceuticals Inc.

Oct 2022 - Oct 2023 (1 year)

Owned clinical QMS and manufacturing quality strategies to ensure compliance with applicable standards (including WHMIS, FDA/HC/EMA/ICH) for drug substance, drug products, and combination products. Directed vendor qualification, ensured GCP adherence for clinical studies, and led pharmacovigilance oversight including PV data management, adverse event reporting, and signal detection.

Clinical Quality Management GCP Compliance Signal Detection 21 CFR 820 ISO 13485

Canadian GxP QA, QC & RA Manager

Edgewell Personal Care

Apr 2021 - Oct 2022 (1 year 6 months)

Managed Canadian GxP QA/QC and regulatory activities, leading implementation of the drug/device QMSR and HSE quality culture and directing quality strategies to meet regulatory requirements. Hosted and led regulatory and internal inspections, maintained vendor qualification programs, restructured quality systems across Canadian sites, and implemented electronic document management systems.

ISO 13485 Inspections Document Management Quality System Restructuring Audit Readiness Change Control Training & Accountability

Canadian QA & PV Manager

Juno Pharmaceuticals Corp.

Apr 2018 - Apr 2021 (3 years)

Led QA and pharmacovigilance for pharmaceutical and medical device operations, overseeing GCP/GMP quality programs across validation/calibration, documentation, training, audits, and inventory control. Managed QA/PV staff and quality governance activities including DEL/MDEL maintenance changes, primary batch review, Annual Product Quality Review, quality control releases, and adverse event process

ISO 13485 MDR 98 282 Batch Change Control CAPA

Quality Management Systems Mgr

Olympus Canada Inc

Sep 2016 - Apr 2018 (1 year 7 months)

Developed and managed a QMS aligned with FDA 21 CFR 820 and ISO 13485 requirements, covering investigations, CAPA, change control, audits, and recalls. Recruited and supervised 13 staff and supported achievement/maintenance of MDEL and ISO 13485 certification while coordinating RA/PV/QA activities and hosting third-party and regulatory audits.

ISO 13485 CAPA Change Control Investigations & Recalls Audit Management