I build Quality systems that protect the product, strengthen operations and enable sustainable business growth.Strategic. Operational. Delivery-focused. Long-term direction translated into practical short- and medium-term milestones.
Connecting Quality, risk, operations and business priorities into one sustainable system.
I build capable, resilient teams that are priority-driven, flexible and focused on what matters most.Using data, risk and experience to drive better decisions and measurable improvement.

Quality Leadership • Transformation • Operational Excellence

© Shahil Singh. All rights reserved.

Impact & Outcome

Impact

Turning Quality, risk and operational discipline into measurable business outcomes.Quality should do more than maintain compliance. It should strengthen execution, reduce risk, improve visibility and help the business grow with control.

Outcomes

Stronger control, faster execution, audit readiness, scalable growth and clearer leadership decisions.Business value for prospective organisations• Lower regulatory and supplier risk
• Driving Operational Efficiency and Sustainable Cost Optimisation
• Faster investigations and closure
• Better audit and market readiness
• Scalable training and governance

Quality Snapshot

75% reduction in NCR investigation & completion time91% of CAPAs closed to KPI — 23% improvement93% of documents reviewed to KPI — 36% improvement100% of NCRs logged within 48 hoursZero critical external-audit observations1,602 training activities  at a 90.33% completion rate

Supplier Risk Prioritisation

Stronger control, faster execution, audit readiness, scalable growth and clearer leadership decisions.Business value for prospective organisations• Lower regulatory and supplier risk
• Faster investigations and closure
• Better audit and market readiness
• Scalable training and governance

Quality leadership that moves from strategy to execution — and execution to results.

Recognition & Professional Impact.

Leadership & Strategic Contribution

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Formal recognition for sustained commitment, professionalism, resilience and contribution to the organisation’s strategic progress.Quality Leadership • Transformation • Resilience • Business Contribution.

Formal recognition for sustained commitment, professionalism, resilience and contribution to the organisation’s strategic progress.Quality Leadership • Transformation • Resilience • Business Contribution.

Enterprise QMS Transformation

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Led and project-managed the transformation from fragmented, paper-based Quality processes to a scalable digital QMS across NZ and U.S. operations — coordinating cross-functional teams, process redesign, role-based governance, CSV/UAT, change control and phased implementation.Delivered: 100% NCR logging • 91% CAPA to KPI • 93% document review to KPI • Zero critical external-audit observationsDigital Quality • CSV & Validation • Cross-Functional Delivery • Governance • QMS Transformation

End-to-End UDI Traceability Project

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Led and project-managed the development of an end-to-end UDI and traceability architecture — moving beyond a label-only solution to connect supply chain, enterprise systems, laboratory workflows and regulatory reporting across the full product and sample lifecycle. I brought Quality, Compliance, Supply Chain, Digital/IT, Laboratories and external partners into one cross-functional programme, with standards-led design, phased implementation, validation, change control, partner readiness and business continuity built in from the outset.Outcome: a scalable global model designed to strengthen regulatory readiness, traceability and recall capability, improve data integrity and operational visibility, and support future market expansion.Strategic Quality Leadership • UDI/GS1 • Systems Integration • Risk & Validation • Cross-Functional Delivery.

Quality Corner — From Quality Culture to Performance Excellence

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Created and evolved an internal Quality communication initiative that made Quality practical, visible and owned across the business — using clear, engaging content to strengthen teamwork, accountability, continuous improvement and smarter use of resources.The series progressed from Quality culture and corrective action, through standardisation, efficiency and accountability, into Performance Excellence — connecting strategy execution, KPI discipline, process excellence, high-performing teams, dynamic thinking and organisational sustainability.Culture → Continuous Improvement → Process Excellence → Performance Excellence
Quality Culture • Team Build • Continuous Improvement • Resource Optimisation • Performance Excellence • Thought Leadership

I turn complexity into control, Quality into performance, and strategy into measurable outcomes.

What I Bring

Industry Experience

Pharmaceuticals & GMP ManufacturingMedical Devices & MedTechBiotechnology & DiagnosticsClinical & Analytical LaboratoriesAnimal HealthHealthcare Logistics & DistributionFMCG, Cosmetics & Personal CarePackaging & Regulated Manufacturing

I build,
I transform
I deliver

I build Quality systems that protect the product, strengthen operations and enable sustainable business growth.Strategic. Operational. Delivery-focused. Long-term direction translated into practical short- and medium-term milestones.Connecting Quality, risk, operations and business priorities into one sustainable system.I build capable, resilient teams that are priority-driven, flexible and focused on what matters most.Using data, risk and experience to drive better decisions and measurable improvement.

Experience

I5+ years across biotechnology, pharmaceuticals, MedTech and supply chain logistics — leading QMS modernisation, operational Quality and multi-site/platform Quality governance..

Pacific Edge Limited

Integrated Quality Leadership — Building a 5-year Quality roadmap and scaling one framework across functions, entities and markets.
**Digital Quality Modernisation — ** Balancing organisational capability, resources and governance through systems, processes, and data-led Quality performance.
Enterprise Quality Transformation — ISO 9001 → ISO 13485/14971 and a future-ready global IVD Quality framework..
Strategy → Market — translating Quality and Regulatory strategy into phased pathways for FDA, IVDR and international
market access..

Quality Assurance Manager | 2022–Present
Biotechnology • Medical Devices • Diagnostics
Transformation Impact: Built the Quality platform for scale — ISO 13485 certification • global market expansion • integrated NZ–US governance • digital Quality modernisation • future FDA/IVD readiness

Argenta Manufacturing Limted

Integrated Quality Leadership — Building a 5-year Quality roadmap and scaling one framework across functions, entities and markets.
**Digital Quality Modernisation — ** Balancing organisational capability, resources and governance through systems, processes, and data-led Quality performance.
Enterprise Quality Transformation — ISO 9001 → ISO 13485/14971 and a future-ready global IVD Quality framework..
Strategy → Market — translating Quality and Regulatory strategy into phased pathways for FDA, IVDR and international
market access..

Quality Assurance Manager | 2022–Present
Biotechnology • Medical Devices • Diagnostics
Transformation Impact: Built the Quality platform for scale — ISO 13485 certification • global market expansion • integrated NZ–US governance • digital Quality modernisation • future FDA/IVD readiness

Marico South Africa

Quality Systems Transformation — Built a more sophisticated, risk-based QMS with structured SOPs, electronic Quality controls and stronger governance across manufacturing operations.
Regulatory → Business Readiness — Advanced South African regulatory-registration activities and supported a third-party manufacturer through its own registration pathway, strengthening external-manufacturing capability and compliance.
Product & Manufacturing Quality — Strengthened stability, raw-material, packaging and laboratory standards while providing Quality oversight across production, warehousing, product development and contract manufacturing.
Risk, Safety & Environmental Transformation — Simplified and formalised chemical, leakage, damaged-product, destruction and hazardous-waste processes, supported by practical staff training and stronger environmental controls.

Responsible Pharmacist / Quality Manager Equivalent | 2018–2019
FMCG • Cosmetics • Personal Care • Healthcare Manufacturing
Transformation Impact: Built and modernised the site Quality operating model.
QMS • regulatory-registration progress • stronger contract-manufacturing governance • product & material standards • risk-based environmental and operational controls

DSV Healthcare

Integrated Quality & Distribution Governance — Embedded risk-based GMP/GDP Quality across pharmaceutical storage and distribution, strengthening audit readiness, validation, CAPA, training and operational control.
Supplier & Service Performance — Built a structured supplier evaluation model linking critical vendors to Quality, contractual and SLA performance requirements.
Operational Resilience & Capacity Strategy — Connected business-impact assessment, BCP, preventative maintenance and facility planning to strengthen asset reliability, capacity and continuity of supply.
Quality → Healthcare Access — Applied regulatory, operational and risk thinking to a Department of Health distribution initiative designed to improve medicine access and reduce patient waiting times.

DSV Healthcare
Responsible Pharmacist / Quality Manager Equivalent | 2016–2018

Pharmaceutical Logistics • Warehousing & Distribution • GMP/GDP
Transformation Impact: Modernised Quality and operational control across healthcare distribution
Risk-based GMP/GDP governance • supplier performance • audit & validation readiness • business continuity • asset resilience • innovative medicine-access pathways

United Pharmaceutical
Distributors

Quality & Operational Transformation — Used QMS gap analysis and cross-functional governance to strengthen distribution Quality, achieving 100% KPI performance across complaints, deviations, audit execution and quarantined-stock release.
Cost → Process Excellence — Re-engineered the Durban destruction process to reduce cost, remove bottlenecks and improve turnaround, while strengthening Critical-to-Quality vendor arrangements.
Digital Quality & Capability — Introduced electronic document storage and video-based SOP training, improving document control, accessibility and workforce understanding.
Customer & Performance Leadership — Connected Quality, Operations and customer service around practical improvement, strong staff leadership and a customer-first mindset while maintaining pharmaceutical standards.

Responsible Pharmacist / Quality Manager Equivalent | 2013–2016
Pharmaceutical Wholesale • Healthcare Distribution • GMP/GDP
Transformation Impact: Turned Quality into operational performance — 100% QA KPI achievement
Lower destruction costs & faster turnaround • digital document control • video-based SOP training • stronger Critical-to-Quality supplier governance*

I lead change that sticks — stronger systems, stronger teams, better outcomes.

What People Say

Trusted by leaders & colleagues across Quality, Operations, Supply Chain & regulated manufacturing

Recommendation Letters

John Mason

Managing Director • Marico South Africa

“Highly competent in his field… with extensive knowledge of and commitment to Quality Assurance”Leadership • Quality Systems • Results • Risk

Ishara Ramkelawan

Supply Chain Executive • United Pharmaceutical Distributors

““His experience, knowledge and ability to innovate were evident in his cost-reduction activities.”Innovation • Operational Excellence • Cost Reduction • Customer Focus*

Sugantha Bheem

Quality Assurance Manager, UTI Pharma

“I strongly believe he will make a positive contribution in any sphere he wishes to work in”Trust • Cross-Functional Leadership • Professional Judgement • Collaboration

Ravina Govender

Quality Assurance Director • DSV Healthcare

'“Shahil has effectively managed regulatory audits, third-party audits, self-assessments and client audits.”
Audit Management • Quality Systems • Product Quality • Risk • Compliance

Mandla Mashilo

Finance Director, Marico South Africa

“His communication and people skills are excellent… bringing innovative ideas.”Innovation • Collaboration • Regulatory Progress • Problem Solving

Michael Bernard Douglas

Deputy Responsible Pharmacist • Marico South Africa

“I have no hesitation in recommending Shahil for any senior position where his experience and expertise will certainly make a valuable contribution.”Quality Systems • Pharmaceutical Operations • Leadership

Video Recommendations

Dianne Macpherson

Responsible Pharmacist - Quality Managing

“Strong sense of ethics & morality”Leadership • Quality Systems • Results

Denise van Heerden

Regional Quality Assurance Manager

“Definately hire him again"Integrity • Team player • Constructive Ideas • Team Contributorustomer Focus*

Norisha Maharaj

Qualified Post-Basic Pharmacist Assistant

“Great Mentor, lots of knowledge & strong motivator”Leadership • Mentor • Motivator

Mpumi Mathibela

Quality Assurance Manager

“Smipilify & merge Operation, Systems & Regulations for easiler user understading & adherence”Supplier Performance • Quality & Contract Agreement • Statistical Acumen

Anne Vassen Prag

Quality Assurance Manager

“My go-to person for anything and everything."Innovation • Collaboration • Regulatory Progress • Problem Solving

Osman Ebrahim Ismail

Branch Manager

“Team Management & sits on and chairs many committtees in the organisation.”Logical • Systematic • Working with Operations

Not just Quality leadership — proven records, stronger systems and measurable results

Beyond Quality

Outside Work

Away from Quality, I value family, good food, travel and time with the people who matter most. I also enjoy experimenting with cooking and anything involving a barbecue or smoker.

Pickleball with the family

Pickleball has become a fun way for me to spend time with my family. We enjoy getting out on court, sharing a few rallies and having a laugh together. It’s a great way to stay active

Growth & Perspective

My career has taken me across pharmaceuticals, healthcare logistics, manufacturing, biotechnology, diagnostics and medical devices — and across different countries, organisations and stages of business maturity.

Continuous Learning

I remain curious about Quality, technology, operational excellence, leadership and how organisations can work smarter — particularly where systems, people and data intersect.

People First

I believe strong performance starts with people. I value trust, accountability, coaching and giving people the confidence and autonomy to succeed.

Resilience & Adaptability

My career has taken me across pharmaceuticals, healthcare logistics, manufacturing, biotechnology, diagnostics and medical devices — and across different countries, organisations and stages of business maturity.

Curious, resilient and people-focused—I bring a growth mindset to every challenge.


My Contact Details

Let’s Connect
Interested in Quality transformation, operational excellence, scalable Quality systems or senior Quality leadership? I’d be happy to connect.
I’m open to conversations around:
- Senior Quality and Quality Systems leadership
- Quality transformation and operational excellence
- QMS, risk and compliance strategy
- Supplier and external Quality
- Digital Quality and governance
- Opportunities across New Zealand and Australia
Get in touch
Email: [[email protected]]
LinkedIn: [https://www.linkedin.com/in/shahilsinghpurequality/]
Location: New Zealand
Open to: Australia / New Zealand opportunities

Thank you

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