Managing Director (AUS) & Global Head of Quality, Principal Consultant

Susan Jones is the Managing Director (AUS) & Global Head of QA, Principal Consultant at Scendea, responsible for the Quality Management System, process improvement including internal audits and leading the development of Scendea’s training program.

Susan has over 25 years’ experience in the CRO industry, including various director roles in operations, quality and vendor management. Sue was the Director of Quality at CNS, where she established the quality group and was responsible for developing the QMS, training, and performing internal as well as local and international contracted audits. Sue holds a BAppSci and is a member of the RQA.

Head of Non-Clinical & Principal Consultant

Ian Waterson is Head of Non-Clinical & Principal Consultant at Scendea, responsible for providing nonclinical scientific and regulatory advice to our clients. Ian was formerly a Senior Non Clinical Assessor at the MHRA and has previously held positions in Sanofi and Covance working both as a Study Director and Toxicology Project Team Representative.

Ian has a strong scientific background with more than 29 years’ experience in drug development and 8 years’ experience as a MHRA regulator. Ian holds an MSc in Applied Toxicology and a BSc (Hons) in Life Sciences.

Principal Consultant

Sheena Emslie is a Principal Consultant at Scendea, responsible for supporting clients with GxP compliance, including conducting audits of vendors, clinical sites, and studies, and preparing clients for regulatory inspections.

Sheena brings over 25 years of experience in operations, compliance, and quality within pharmaceutical and biotech industries, including 15 years in senior leadership. She began her career at Aspen South Africa, later moving into clinical research quality in the early 2000s. Then in 2008 she returned working to pharmaceutical industry, and before shifting to the biotechnology sector in 2018 with a focus on quality and leadership roles in early clinical development.  Her expertise spans GCP and GMP regulations under PIC/s, ICH, TGA and FDA, with some GLP experience, and core skills include quality, compliance, project management, leadership and risk management.

Principal Consultant

Felicia Ford-Rice is a Principal Consultant at Scendea, responsible for supporting clients with GCP, GMP, GVP and GLP compliance, including regulatory inspection preparation, audits & assessments, training, process improvement, investigations, SOP development.

She was formerly Executive Director, Audits & Compliance at Daiichi Sankyo, with over 25 years’ experience in the pharmaceutical/biotech industry and executive positions at Parexel International, Astellas; research-based roles at Sanofi, Sterling Drug, Johns Hopkins, National Institute on Drug Abuse. Felicia has led multiple Quality Assurance functions from pre-clinical through clinical development and commercialization. She holds BS and Master of Management degrees; Certificates in Project Management, Leadership, Management, Biopharma Innovation; and is certified in Regulatory Affairs (RAPS).

Principal Consultant

Richard Hughes, Principal Consultant at Scendea, excels in analyzing organizational stability cycles and discovering compliance discrepancies within various regulations like Animal Welfare, GLP, GCLP, GCP, and GMP. With a deep understanding of quality systems and global trends, he guides clients through regulatory complexities.

Richard’s vast experience spans CROs, bioanalytics, pharmaceuticals, research, and medical devices, reflecting his dedication to scientific rigor. Previously, as Senior Manager at Pharmaron CPC and Director of Quality Assurance at Amador Bioscience, he significantly improved quality processes. Richard holds a Bachelor of Science in Laboratory Management.

Principal Consultant

Dr Kevin Kuo is a Principal Consultant at Scendea, responsible for supporting clients with GMP compliance, including conducting audits of vendors and preparing clients for regulatory inspections. With over 25 years of experience, Kevin specializes in CMC and manufacturing for challenging modalities such as ADCs.

 Kevin has held several leadership roles at AstraZeneca, Samsung, Takeda, Novo Nordisk and Lonza. He served in directorate positions at AstraZeneca and Samsung, managing global technical operations, technology transfers and process validation. He has extensive expertise in greenfield facility design and leading successful regulatory filings globally. Kevin holds a PhD from the University of Cambridge.

Principal Consultant

Leila Mapson is a Principal Consultant at Scendea, responsible for supporting clients with GCP compliance, including conducting audits of vendors, clinical sites, and studies, and preparing clients for regulatory inspections.

Leila has over 25 years’ experience in the pharmaceutical and biotech industry with extensive experience in CRO oversight, site GCP audits, clinical trial operations and project management. She is known for her collaborative approach, attention to detail, and commitment to GCP and regulatory excellence. Leila builds strong partnerships with stakeholders, consistently supporting the successful delivery of complex clinical trials. Leila holds a BAppSci, a certificate in Lead Auditor of Quality Management Systems, and is a member of the RQA.

Principal Consultant

Jennifer Martin is a Principal Consultant at Scendea, responsible for supporting clients with GCP compliance, including conducting audits of vendors, clinical sites, and studies, and preparing clients for regulatory inspections.

Jennifer specialises in EU and UK regulations, guidance, and intelligence, and has over 30 years of experience in the pharmaceutical industry. Jennifer began her career with 12 years in GLP and GCP environments before spending 15 years at the UK regulatory agency, where she started as a GCP Inspector and progressed to Lead Senior and Operations Manager. She subsequently returned to industry as Director of Quality prior to moving into consulting. Jennifer holds a BSc in Chemistry and is a member of the RQA.

Principal Consultant

Tamara Miller is a Principal Consultant, responsible for providing product development, operational support, strategic advice, and oversight. Tamara has over 23 years’ experience in the pharmaceutical, biotech, and CRO industries and has held senior positions at ICON Clinical Research, Actinogen Medical, and Myopharm Limited.

Tamara has substantial experience in the full cross-functional product development life cycle and she has worked across a broad range of therapeutic areas, with a focus on neuroscience, endocrinology, infectious diseases, and oncology. Tamara holds a BSc in Biomedical Science, a Diploma of Business, and is a certified Project Management Professional (PMP).

Principal Consultant

Dr Anthony Newcombe is a Principal Consultant at Scendea, responsible for supporting clients with Regulatory CMC, Quality Assurance and GMP compliance associated with the manufacture of biologics, advanced therapies, vaccines and antibody-drug conjugates and biosimilars.

Anthony conducts GMP audits of manufacturing facilities and supports companies in preparing for regulatory inspections and ensuring compliance with FDA and other global regulatory authorities. He has over 25 years’ experience in the biopharmaceutical industry and has held technical leadership roles at Samsung Biologics, GSK and Pfizer. He is an IRCA qualified GMP Lead Auditor and holds a PhD in Biochemistry.

Principal Consultant

Karen is a Principal Consultant at Scendea, responsible for providing nonclinical technical advice and product development strategies to our clients. Karen was formerly a Senior Nonclinical Assessor and Head of Nonclinical Assessment for Clinical Trials at the MHRA.

Karen has over 20 years’ experience in toxicology, having also previously worked for the NHS and Food Standards Agency. Karen holds a BSc (Hons) in Pharmacology and an MSc in Applied Toxicology.

Principal Consultant

Dana Votin is a Principal Consultant at Scendea, responsible for supporting clients with GCP compliance, including conducting audits of vendors, clinical sites, and studies, and preparing clients for regulatory inspections. Dana has worked as a Quality Consultant for the last five years (both independent and full-time for ProPharma Group), and previously in the CRO space (Theorem, ICON, RPS, PRA, PSI), starting as an Auditor up to Quality Director of the Americas.

Dana has extensive experience in a variety of vendors utilized in clinical trials and a strong background in the sciences with a Bachelor's in Molecular Biology and Biochemistry and a Master's in Biology.

Principal Consultant

Leanne West is a Principal Consultant at Scendea responsible for providing regulatory and clinical development strategies to clients. Leanne has over 28 years’ experience in the biotechnology, pharmaceutical and CRO industries. Leanne has a broad level of experience across all phases of drug development and project management. Therapeutic areas include Infectious disease, oncology, women’s health, cardiovascular disease and vaccines. Leanne has expertise in first-In-human trials and the regulatory hurdles required to move new agents into the clinic.

Leanne has held senior positions at Prescient Therapeutics, Novotech, Clinical Network Services and Novogen Limited and has also consulted multiple biotechnology companies to facilitate their clinical development. Leanne holds a BBiotechnology (Hons).

Principal Consultant

Dr Babaji Yadav is a Principal Consultant at Scendea, responsible for providing strategic Nonclinical/toxicology and clinical development advice to clients in support of global development programmes. He has over eight years of academic experience in pre-clinical oncology drug development, and ten years of industry experience in early phase clinical development and nonclinical consulting.

Babaji has prior experience in the Pharmaceutical, Biotech, and Clinical Contract Research Organization (CRO) industries, having worked at companies such as Sanofi-Aventis, Kazia Therapeutics, IQVIA, Clinical Network Services, and Novotech. Babaji is a registered EU/UK toxicologist and serves as an independent reviewer toxicologist on the Bellberry Human Research Ethics Committee (HREC) in Australia. Babaji holds a PhD in Pharmacology and Toxicology.

Principal Consultant

Dr Bertjan Ziere is a Principal Consultant at Scendea, responsible for providing regulatory and non-clinical development strategies to clients, as well as supporting GLP and GMP compliance, including conducting audits of vendors, nonclinical CROs, and studies, and preparing clients for regulatory inspections. Bertjan was most recently VP and Head of Preclinical Development & CMC at Leyden Laboratories BV and has over 20 years working as an independent consultant, focussing on non-clinical development, regulatory affairs, CMC and Quality Assurance.

Bertjan has a strong scientific background with more than 25 years of experience in pharmaceutical development and has provided strategic, scientific and regulatory guidance for a range of (bio) pharmaceuticals including vaccines, recombinant proteins, and gene therapies. Bertjan holds a PhD in BioPharmaceutical Sciences.

Senior Quality Assurance Manager, Senior Consultant

Dr Layne Baird is the Senior Quality Assurance Manager, Senior Consultant at Scendea, responsible for the management and continuing improvement of the Quality Management System and internal audit program. In addition, Layne is responsible for providing client quality support services including GCP and GMO audits, QMS development and quality assurance activities.

Layne has over 25 years experience in preclinical and clinical research, holding senior positions in QA, auditing and clinical project management in early phase CROs and postdoctoral preclinical research roles in neurobiology and cardiovascular research. Layne has expertise in GMO monitoring and compliance and study conduct in Australia and has held positions on Institutional Biosafety Committees. Layne holds a BSc (Hons I) and PhD (Physiology).

Senior Consultant

Polly Kennard is a Senior Consultant at Scendea. Polly is responsible for authoring and management of regulatory submissions to US and European agencies, as well as providing support to clients within her role as project manager.

Polly has many years of experience in pre-clinical drug development, in the CRO pharmaceutical and biotech industry. Polly has experience in the field of toxicology and safety pharmacology, and has worked in a number of therapeutic areas including neurological, respiratory and infectious diseases. Polly holds a BSc (Hons) in Pharmacology from the University of Hertfordshire and is a Member of the Royal Society of Biology, British Toxicology Society and American College of Toxicology.

GVP Services

GVP Services are delivered by Scendea’s Pharmacovigilance Partner, Signal, providing clients with reliable, expert support in line with global regulatory requirements.