leadership and management team
Mark McComish BA (Acc), FCA.
Mark McComish, FCA, is Director of Finance and Operations with The Compliance Group. Mark is responsible for the development and implementation of the Company’s business development strategy and for the management of the Company’s experienced team of Consultants. Mark is a Dublin City University graduate and a fellow of the Institute of Chartered Accountants in Ireland.
Stan O’Neill BSc (Pharm), MPSI
Stan O’Neill is the Managing Director of The Compliance Group. After qualifying as a Pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (QP) and then joined the Irish Medicines Board (IMB), now the Health Products Regulatory Agency (HPRA), for a period of ten years.
Deirdre Walsh BSc (Computer Science), PMP
Deirdre Walsh is the Business Operations Manager with The Compliance Group. Deirdre is PMP-certified, with a background in managing business operations and delivering projects across various industries, from pharmaceuticals, banking, insurance, to education. She has a Bachelor’s degree in Computer Science with additional qualifications in Project Management, Scrum Master, and Digital Marketing.
senior regulatory consultants
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Dearbhla Byrne B.Sc. Biochemistry
Dearbhla is a Senior Regulatory Consultant at The Compliance Group with over 20 years of experience in the Pharma and Biopharma industry. She has held various roles in QA, QC, QP, NPI, and validation. She holds a BSc (Hons) in Biochemistry, an H. Dip in Biotechnology, and an H. Dip in Pharmaceutical Manufacturing Technology (Qualified Person qualification).
Previously, Dearbhla was a GMP Inspector with the Health Products Regulatory Authority (HPRA), leading GMP inspections worldwide and collaborating with international inspectors for both the HPRA and European Medicines Agency. She was a registered biotechnology expert with the European Medicines Agency and has extensive experience inspecting sterile, non-sterile, biotech, IMP, and ATMP manufacturing facilities, as well as contract laboratories, gamma irradiation, ETO, and compounding facilities. Dearbhla has presented at HPRA information days, QP forums, and industry conferences, and contributed to updating Eudra GMP guidance documents.
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Denise Coakley BSc., MSc.
Denise holds a Master’s Degree in Industrial Pharmaceutical Science, certifying her as a Qualified Person (QP). She has twelve years of experience in the pharmaceutical and biopharmaceutical industry, working internationally in various departments, including laboratories, quality, validation, clinical, project management, and QP roles on both start-up and operational sites. In 2011, Denise joined the Irish Medicines Board (now the Health Products Regulatory Authority) as a GMP inspector. She led and conducted GMP inspections worldwide, representing the HPRA and the European Medicines Agency, assessing manufacturers’ compliance with EU GMP. Denise has inspected sterile, non-sterile, biotech, and IMP manufacturing facilities, contract laboratories, gamma irradiation, ETO, and compounding facilities. She also trained new inspectors at PIC/S GMP inspector training and presented at HPRA information days and QP forums.
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Kevin Sweeney PhD, MA (Criminology)
Kevin Sweeny is a senior regulatory consultant with The Compliance Group.
Kevin served with the Irish Army before joining An Garda Síochána where he spent over 30 years in various roles as both a detective and a sergeant. Kevin holds a Master in Criminology and a PhD in Interview Techniques. He specialises in the areas of interviewing, fraud detection and evidence collection. Kevin occupational Police Training included Criminal Assets Profiler, Anti-Counterfeiting Operations LEA, Intellectual Property Fraud Investigator and Rural & Close Target Reconnaissance.
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Paula Dillion Bsc, MSc.
Paula Dillon is a senior regulatory consultant with The Compliance Group, specializing in controlled drugs and Good Distribution Practice (GDP). She worked in the pharmaceutical sector before earning a master’s degree in Forensic Science. In 2002, Paula joined the IMB as a scientific officer, overseeing the transfer of controlled drugs licensing from the Department of Health and Children. She represented Ireland at the EU Drug Precursor Committee and Working Group meetings. In 2006, Paula became an inspector, conducting GDP and controlled drugs inspections, and represented the IMB at PIC/S GDP Working Group meetings and the EMA GDP Drafting Group, acting as Rapporteur. She also trained as a GMP Inspector for API manufacturing. Paula has served as Head of Quality for an Irish distributor and as the Responsible Person for two wholesalers. She holds a Master’s Degree in Industrial Pharmaceutical Science, qualifying her as a QP, and has experience as a Quality Assurance Supervisor in an API Manufacturer.
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Richard Bierney BSc (Hons)
Richard Bierney is a Senior Regulatory Consultant with The Compliance Group with expertise in the practical application of the Operational Aspects of Good Manufacturing Practice. Richard has over 25 years’ experience in the Pharma and Biopharma Industry. During that time, he held a number of Quality, Operational and Leadership roles within Sanofi, Schering Plough, Amgen and Genzyme. Additionally, Richard has 2 years’ experience with the Irish Medicines Board, now the HPRA, where he was a GMP Inspector. Richard also has a demonstrated background in the use of the Continuous Improvement Tools associated with Lean as a mechanism to improving Quality and Compliance within an Organisation.
senior consultants
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Ann Ballesty Senior Consultant
Ann is a quality professional with more than 25 years of management experience in Pharmaceutical, Medical Device and Cosmetic manufacturing. Roles to date have included responsibility for site Quality assurance, compliance, quality control, regulatory affairs, new product introduction, process transfer and scale up and validation. She has also worked in international corporate roles in the supply-chain management (due diligence auditing, GxP auditing and contractor oversight) for both clinical and commercial pharmaceutical manufacture and medical devices. She has participated in teams which have successfully passed their first GMP & GDP license applications and NDA inspections. As part of continuous improvement Ann has been involved in working on improved technical writing skills and human error reduction programs.
Product types and processes with which she is familiar include small molecule APIs, bulk drug substances, medical devices and finished pharmaceuticals and biopharmaceuticals. Dosage forms include lyophilized products, aseptic filling, liquids & tablets, creams, sachets, powders and patches.
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Arlene Hynes, B.Sc (Hons), H.Dip. Pharm. Man. Tech
Arlene is a senior pharmaceutical professional with over 30 years of experience in Quality Assurance, Quality Control and Quality Systems. Arlene has a broad range of experience across the pharmaceutical industry. She has technical expertise and hands-on experience of quality management systems for both in-house and third-party manufacturing, packaging and analysis. In addition she is an experienced auditor.
Arlene obtained a BSc in Analytical Chemistry followed by the Post Grad Diploma in Pharmaceutical Manufacturing and has been a licensed QP since 2008. Arlene has worked as Quality Manager and QP in several companies.
Arlene has gained experience releasing a variety of medicinal products, which include sterile medicinal products (both aseptic fill and terminally sterilised), parenteral nutrition, suspensions and solid dose products.
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Bernadette O’Brien BSc (Hons), P Grad Dip. Mfg Tech, MBA
Bernadette is a Senior Consultant and Qualified Person at Compliance Management (formerly eups) with over 20 years’ experience in the Pharma and Biopharma industry. Bernadette has an Honours Degree in Pharmacology and a Master Degree in Business Administration. She held a number of senior quality leadership roles before being appointed as Head of Quality with responsibility for Quality Assurance, Compliance, Quality Control Chemistry, Microbiology, Regulatory Affairs and Validation. She has worked at IVAX, Teva, Genzyme and Sanofi with both clinical and commercial products, across aseptic filling, oral dose and inhalation platforms. Bernadette has extensive experience in hosting inspections with HPRA and US FDA, in addition to experience with Regulatory Inspections by CFDA, Canada, Russia, Korean, Turkey, Brazil, Japan and GCC. With expertise in Quality Systems and Operational Quality Compliance, Bernadette has a proven capability in Technical and Analytical Transfer, Product Life Cycle Management, Quality Risk Management and Human Error.
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Ehab Nofal Senior Consultant
Ehab is a pharmaceutical manufacturing professional with more than 17 years of management experience in Pharmaceutical manufacturing. Roles to date have included responsibility for site Quality assurance, compliance, quality control, regulatory compliance, new product development, process transfer, scale up and validation.
He has also worked in due diligence auditing, GxP auditing and contractor oversight for commercial pharmaceutical manufacture. Successful track record in leading compliant operations with a deep understanding of what it takes to run a compliant organisation. Significant exposure to numerous internal and external audits for pharmaceutical manufacturing sites. Demonstrated application of quality understanding in the manufacture of pharmaceutical products within multiple organisations. Strong technical knowledge of all Pharmaceutical Operations.
Specialties:
Quality systems building & implementation, GxP compliance, Project management, Product improvement, Product preparation for launching, Quality auditing, CAPA, Regulatory Affairs, Production management, pharmaceutical processing, Leadership, CMOs auditing and ratings.
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Francis Bates, BSc, Phd, Chemistry
Francis is an experienced pharmaceutical operations leader with over 35 years of experience with a proven track record of delivering major projects, including people change management. He is an effective communicator with a strong technical background.
During his career Francis was responsible for an OSD manufacturing network supporting $4B revenue,
managing 1000 employees. Francis delivered on-time commercialisation of multiple NPIs, including 6 NDA/PAI approvals in 3 years. He also led the design, development and deployment of a “paperless QC laboratory” for batch release and stability.
Francis’ experience as a Site General Manager includes turnaround and recovery, managing through several mergers and acquisitions, and strategic site development. He believes the clear articulation of a site’s strategic value to the company is fundamental to its continued development. He is familiar in dealing with state agencies.
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Gemma Lawlor Senior Consultant
Gemma is a qualified Pharmacist having qualified with a BPharm from UCC followed by an MPharm from RCSI. She has worked both in community pharmacy and also in the pharmaceutical industry. Gemma has worked as both a Qualified Person and Quality Manager in several companies, ranging from startups to multinationals.
Gemma has gained experience releasing a variety of medicinal products, which include sterile medicinal products, chemotherapy products, antibiotic products, parenteral nutrition, gels, creams, ointments, and solid dose products. Gemma has experience in both setting up and managing/maintaining Quality Management Systems. She is also a trained auditor. Gemma is a qualified life and business coach and is lead coach in her own coaching business.
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Martin Kierans BSc (Hons), MSc
Martin Kierans is a senior pharmaceutical professional with over 20 years of experience in Quality Assurance, Quality Control and Quality Systems. Martin has a broad range of international experience across the pharmaceutical supply chain. He has technical expertise and hands-on experience of quality management systems for: in-house and third party manufacturing, packaging and analysis; affiliates and MAH activities including pharmacovigilance, sales & marketing and GDP. Martin earned his Msc degree in Instrumental Analytical Chemistry from Anglia Polytechnic University, Cambridge UK, his BSc (Hons) degree in Analytical Chemistry with Quality Assurance from Cork Regional Technical College and his Postgraduate Diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin. He is an eligible QP since 2009.
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Orla Campbell, MSc, BSc(Hons), MRSC
Orla joined as a Senior Consultant at Compliance Management (formerly eups) in 2019. She has a diverse range of experience from Development, Clinical Trial/IMP, Manufacturing, Validation, CQV, pharmacovigilance, QMS and Regulatory as well as hosting HPRA and FDA inspections for new products and experience in GMP, GDP and Pharmacovigilance audits.
She obtained QP status in 2004 , and has had 15 years’ experience of QP and IMP/IND certification over a wide range of medicinal products including solid dose pharmaceuticals, Inhalation products, sterile medicinal products and various Combination products.
She held a number of senior Quality and Leadership roles responsible for Manufacturing Site builds, Quality Assurance, QMS Design, development and Improvement projects, CQV and Process Validation Device Design, Medical Devices, Quality Control, Method Development and Transfer and Contract Manufacturing operations including auditing to GMP. GDP, CFR 820, ISO 13485 and CFR Part 4
