Abdul Waheed

Experienced pharmaceutical, quality & regulatory affairs leader with over 18 years of strategic, scientific, and operational expertise across integrated drug discovery, biobanking, diagnostics, and medical devices/IVDs development. My career has centred on enhancing patient-focused therapeutic solutions in oncology, cardiology, and immunology while building high-performing teams and implementing robust Quality Management Systems that support scientific excellence and sustained regulatory compliance.

I have led large, multidimensional operations—including heading the Compound Management Department at BioAscent Discovery Ltd.—where I managed US and European drug discovery programs for large compound libraries screening, designed simplified workflows, in-house capital expansion projects, digital transformation initiatives, and AI-ready automation platforms. As part of the executive management team, I contributed to corporate strategy for quality governance, regulatory compliance, and systems optimisation, ensuring alignment with organisational, regional, and cluster-level objectives.

My regulatory background spans MHRA, HTA, MDR, IVDR, ISO 9001, ISO 13485, ISO 14001, ISO 45001, ICH, GMP, GLP, and GCP frameworks, with hands-on experience authoring technical documentation, Clinical Evaluation Reports (CERs), risk assessments to ISO 14971, and overseeing submissions for EU CE marking and for UK UKCA marking. I have supported regulatory inspections, driven audit readiness, and managed CAPA, Vigilance, and FSCA-related processes with a focus on maintaining high standards of safety, traceability, and compliance.

Recognised for a collaborative and inclusive leadership style, I excel at translating complex scientific and operational challenges into clear, actionable strategies that standardise processes, strengthen QMS performance, enhance KPI delivery, and elevate customer satisfaction. I am committed to fostering a culture in which teams are empowered to innovate, anticipate risk, embrace change, and deliver measurable quality outcomes.

Manager – Compound Management | Feb 2024 – Nov 2025

BioAscent Discovery Ltd., Glasgow, Scotland, UK

• Led the Compound Management Department, aligning operations with corporate strategic objectives.
• Delivered end-to-end compound management services, including procurement, aggregation, registration, reformatting, pooling, and global logistics.
• Served as a member of the BioAscent Executive Management Team, contributing to pipeline planning, business development, and future opportunity evaluations.
• Oversaw the centralised compound management system, implementing automation, embedded workflows, API integrations, AI-ready knowledge systems, and compliance measures.
• Project-led a £2.8M automated –20°C compound storage system, managing design, validation, and integration.
• Integrated Titian Mosaic software and developed custom APIs to connect internal systems with client API-led HTS platforms.
• Collaborated with Business Development to launch the “Compound Management Welcome Pack,” streamlining client on boarding and engagement.
• Developed and reviewed RFPs and SOWs to support clients in project design, workflow selection, costing, and timely delivery, ensuring alignment with company financial objectives.
• Managed deviations, incident reporting, change controls, CAPA development and continuous improvement initiatives.
• Delivered operational KPIs, quality dashboards, customer satisfaction metrics and ensured alignment with corporate Quality Objectives.
• Supported audit readiness for MHRA-aligned quality requirements, ISO 9001 frameworks and customer audits.
• Built a high-performance team with competency frameworks, training, 1:1s and performance reviews.

European Device Solutions Ltd. (EDSL), Whitley Bay, UK

• Qualified Lead Auditor for ISO 13485:2016, with extensive experience designing, implementing, and maintaining Quality Management Systems for biotech and medical device/IVD organisations.
• Developed and established end-to-end QMS frameworks for biotech clients in alignment with ISO 13485, including drafting, reviewing, and managing documentation across Quality Manuals, SOPs, Work Instructions, and controlled forms and records.
• Authored complete Technical Files and Clinical Evaluation Reports (CERs) for Class I, IIa, IIb medical devices and IVDs to support successful UKCA and CE marking, ensuring compliance with MEDDEV 2.7/1 Rev. 4 and MDR 2017/745 –IVDR 2017/746 requirements.
• Remediated Technical Documentation from MDD 93/42/EEC to MDR 2017/745, ensuring full alignment with General Safety and Performance Requirements (GSPR) and updated regulatory expectations.
• Performed comprehensive risk management activities, including IHA and FMEA in accordance with ISO 14971:2019, and completed Essential Requirement / GSPR gap assessments to MDR 2017/745 Annex I.
• Conducted ISO 10993 biological evaluations and developed PMS and PMCF documentation to maintain compliance throughout the product lifecycle.
• Supported regulatory inspections and audits under MDSAP, MHRA, FDA, and TGA, ensuring audit readiness and strong governance across all quality and regulatory processes.
• Prepared EU/EC and UK Declarations of Conformity and contributed to lifecycle regulatory submissions for CE- and UKCA-marked devices, including ECR, CAPA, PSUR, and PMS updates.

Hybrisan Technologies Limited, Wales, UK

• Led the Innovate UK project to develop Nano-Spider Electrospinning Technology, translating nanofiber antimicrobial and anti-biofilm activity into viable medical devices.
• Designed and implemented R&D strategies for antimicrobial and anti-biofilm wound care technologies, including product concept, lab workflow management, and staff training and performance evaluation.
• Managed project planning, start-up launches, and cross-functional collaboration to ensure timely delivery of research outcomes.
• Implemented a comprehensive Design Control Process, overseeing the full product lifecycle from concept to post-production, including:
• Conceptual and pre-production design activities
• Definition of User Requirements Specifications (URS) within the Design History File (DHF)
• Transfer of formulations and processes into the Device Master Record (DMR)
• Establishment of Device History Records (DHRs) to support batch records, QC testing, in-process checks, validation batches, and CAPA management.
• Led product optimization, prototype scale-up, and process validation to generate data for DHR documentation and regulatory submissions.
• Developed complete technical documentation for Class IIb medical device registration, supporting UKCA marking submissions.
• Collaborated with commercial partners and regulatory teams to conduct ISO 10993 biocompatibility testing and compile technical files for CE/UKCA compliance.

SRG Synergy – Cignpost Diagnostics, UK

• Served on the Strategic and Operational Management Committee, contributing to business development initiatives, including new lab setups, assay selection, logistics, and operational protocols.
• Directed COVID-19 laboratory operations ensuring quality, accuracy, and compliance with ISO 17025:2017 standards and SLA requirements for B2B and D2C models.
• Led in developing Quality Management System and compliance, including daily operations, SOP adherence, validation protocols, and controlled documentation, internal audits, and technical document reviews in line with ISO 15189:2012, MHRA and UKAS regulation.
• Conducted CAPA investigations for deviations, non-conformances, OOS results, and complaints, ensuring timely corrective actions and robust documentation. Oversaw data integrity, result accuracy, SLA-driven reporting, and complete sample logistics, including chain of custody and traceability.
• Managed and trained scientific teams through competency-based programs, promoting a strong Health & Safety culture across regional labs.
• Drove UKAS accreditation efforts, stakeholder engagement, and business strategy development to strengthen operational performance and regulatory alignment.

NHS Lighthouse COVID-19 Testing Lab, Imperial College London, UK

• Established and managed London’s first NHS Lighthouse Laboratory for SARS-CoV-2 RNA screening, overseeing end-to-end testing operations.
• Led the setup and project management of COVID-19 PCR testing workflows, including SARS-CoV-2 RNA extraction and RT-PCR testing.
• Provided technical expertise for all laboratory processes, serving as the primary contact for troubleshooting CyBio Felix and other automated RNA extraction platforms.
• Managed staff, including training, competency assessments, and performance evaluations, ensuring compliance with MHRA, UKAS, Quality Management System (QMS), and health & safety regulations.
• Oversaw laboratory logistics, procurement, and resource planning, including Oracle-based procurement optimization, to support efficient, compliant operations, line management, health & safety compliance.

Phillips Pharmacy – Pillbox Group, London, UK

• Developed sustainable clinical and operational platforms.
• Conducted audits, risk assessments, and governance activities to ensure patient and staff safety.

Centre for Experimental Medicine and Rheumatology (EMR)

William Harvey Research Institute – Queen Mary University of London, London, UK

• Established a Research Biobank at the EMR Centre, creating central biopsy collection sites across London hospitals and securing rare pathology samples from partner institutions.
• Directed Biobank operations, ensuring full compliance with HTA, GCP, MHRA, and FDA standards for patient consent, sample processing, DNA/RNA extraction, QC, and storage.
• Enhanced sample quality by implementing an in-house grading system and biomarker strategies to ensure consistency and support ongoing clinical studies.
• Implemented digital biological sample tracking systems, including Item Tracker for sample traceability and an integrated clinical data management portal in collaboration with software engineers.
• Led audits, inspections, and ethics committee activities, establishing regulatory strategies and maintaining compliance with GCP, GLP, and European guidelines.
• Managed multi-site clinical trials, overseeing study design, protocol development, data analysis, and project completion within timelines and budgets.
• Developed an in vitro organ culture model using the CD40/CD40L complex to predict anti-TNF therapy response in rheumatoid arthritis patients, including histological, ELISA, and FACS analyses.
• Optimized laboratory operations and budgets by improving SOPs, process validation, and vendor negotiations for cost efficiency and quality control.

School of Biosciences and Medicine, University of Surrey, Guildford, UK

• Established and managed a cardiac tissue bank of human left atrial appendage samples to support the Heart and Stroke Trust Endeavour (HASTE)–funded research programme.
• Investigated novel regulatory pathways influencing atrial gap junction conductance, identifying the role of intracellular phosphatases in the phosphorylation of connexins (Cx43 and Cx40).
• Identified and evaluated circulating microRNA biomarkers in blood samples from patients with coronary artery disease and cardiac arrhythmias, applying statistical analyses to determine candidates with strong diagnostic and prognostic potential.

• Research project: “Identification of molecular targets of flavonoids: A focus on polycystin-2 ion channels in renal epithelial cells.” Funded by the Southwest Academic Network, UK.

• Dispensing prescribed medicines and pharmacy assistance 

• Led operational management of pharmaceutical manufacturing processes for solid oral (tablets), liquid, and sterile injectable products, including compounding and lyophilisation, within Class I cleanroom facilities under GMP and ISO 9001 standards.
• Ensured product quality through in-process controls, process validation, and support of new product development, third-party manufacturing, and manufacturing process optimisation.
• Provided technical input into the development of production master plans and manufacturing strategies.
• Investigated process deviations and non-conformances, implemented CAPA initiatives, and drove continuous improvement in manufacturing operations.
• Managed and investigated market complaints, producing detailed root-cause analyses and corrective action reports to address manufacturing deviations and prevent recurrence.

• PhD – Pharmaceutical Sciences | May 2007 – Mar 2011

  School of Pharmacy and Chemistry, Kingston University, London, United Kingdom

• MPhil – Pharmaceutical Sciences | Sep 1999 – Jan 2001

  Faculty of Pharmacy, Gomal University, NWFP, Pakistan

• BPharm – Pharmacy | Sep 1994 – Aug 1998

  Faculty of Pharmacy, Gomal University, NWFP, Pakistan