Meet Our Team
A Team of Industry Leaders and Former Regulators
BioEthica leverages hundreds of years of combined experience in life sciences, alongside extensive regulatory expertise gained from work with global health authorities and the US FDA.
This enables us to provide clients the knowledge they need to safeguard biologics, drugs, advanced therapeutic medicinal products, and combination products from early phase clinical trials to commercialization.
Former Regulators. Industry Veterans. Scientific Leaders.
Tara Greene is a pharmaceutical quality and regulatory expert with over 25 years of experience spanning the FDA, industry, and consulting. She has led quality systems for a wide range of products including radiopharmaceuticals, biologics, and cell and gene therapies guiding companies through inspection readiness, regulatory remediation, and compliance from development to commercialization. Tara founded BioEthicA, LLC and has held executive roles at organizations such as Orchestra Life Sciences, Inozyme Pharma, Patheon Biologics (Thermo Fisher), and the U.S. FDA, where she was a Level III Certified Drug Investigator and Pharmaceutical Inspectorate specializing in complex biotech and sterile manufacturing inspections.
Tara has advised companies including Jazz Pharmaceuticals, Curium, and Daiichi Sankyo on mock inspections, gap assessments, and technical quality strategies. A sought-after speaker on GMPs and regulatory expectations, she has presented at industry symposia such as PDA, Cedars-Sinai, and CIRM. She holds an M.S. in Biomedical Quality Systems from San Diego State University and a B.S. in Animal Science from Kansas State University, and completed an FDA sponsored Biomanufacturing training at North Carolina State University’s Golden Leaf BTEC program. ASQ-certified and recognized with multiple FDA awards, Tara combines regulatory insight, technical depth, and practical leadership to drive excellence across the pharmaceutical landscape.
Michael Greene is a decisive operations executive and Chief Operating Officer at BioEthica, driving strategic growth, financial performance, and supply chain excellence in pharmaceutical consulting.
With a strong background in FDA-regulated manufacturing, SaaS-driven process optimization, and military leadership, he has led large-scale transformations, improved P&L performance, and enhanced regulatory compliance.
A certified expert in Lean, Six Sigma, and TPM methodologies, Mike combines ethical leadership with data-driven decision-making to optimize efficiency and ensure sustainable growth. Holding an MBA and multiple industry certifications, he is committed to operational integrity and continuous improvement, positioning BioEthica for long-term success.
Dr. Workman has more than 15 years of experience in academia and the biopharmaceutical industry. She specializes in regulatory strategy, CMC change management, tech transfers, compliance gap analyses, and risk mitigation for drug products.
Her technical background focuses on cell- and antibody-based immunotherapies, antibody-drug conjugates (ADCs), and radioligand therapies for cancer and autoimmune disease.
Lauren has overseen nearly 200 regulatory submissions to FDA, MHRA, EMA, Health Canada, SAHPRA, and TGA—including initial applications, CMC information amendments, agency inquiries, and post-approval variations and commitments.
Myshoska has over 20 years of experience in healthcare, pharmaceutical, biotechnology, validation, and quality, supporting the development of novel biopharmaceutical therapeutics and enhancing compliance with both the Code of Federal and EMA regulations to promote site excellence and ensure the safety and efficacy of drug products.
As a strategic growth leader with extensive hands-on management and quality experience, Myshoska has successfully led teams through transitions from clinical-focused to commercial-focused manufacturing and quality release.
Dave West is a strategic operations and technology leader known for driving innovation, efficiency, and growth across several industries. His passion for continuous improvement and strength in connecting business goals to practical solutions, has helped organizations unlock value through collaborative leadership and improved systems and processes. His expertise in strategic planning, change management, and technology has consistently produced measurable results and positioned teams for long-term success.
In his post recent role at a Top 500 accounting firm, Dave partnered with executive leadership to modernize operations and lead enterprise-wide initiatives. He’s also held leadership positions in healthcare and biotech, managing complex IT ecosystems and leading regulatory-compliant system implementations. Dave holds a B.S. in Communications from South Dakota State University and certifications in ITIL, system validation, and document control for regulated industries.
Dr. Mellquist has over 25 years’ experience in the health care field and has held positions in government, industry, and as a consultant. Jenny is knowledgeable with all phases of the product lifecycle from early development to commercial products. Since 2010, Dr. Mellquist has been a consultant where she focuses on providing regulatory strategy for complex dossiers.
She is also a former FDA product specialist inspector and continues to support clients’ CMC regulatory strategy, mock audits, and provide professional and inspectional expertise to clients.
Wes brings over 40 years of experience leading analytical and technical services in support of biologics development and manufacturing for Pfizer and a range of consulting clients. His work has supported a wide variety of marketed products, including monoclonal antibodies, recombinant proteins, vaccines, ADCs, pegylated proteins, oligonucleotides, enzymes, and antibiotics.
A distinguished contributor to the United States Pharmacopeia (USP), Wes has served as a volunteer since 1992, holding leadership roles on numerous Expert Committees and Panels. From 2010 to 2020, he served on the USP Council of Experts, helping guide the development of global quality standards. He is currently recognized as an Honorary Member of the USP Convention and continues to support its mission.
Laura is a PMP-certified Senior Project and Program Managing Consultant with over 40 years of experience, including 30 in healthcare contracting across life sciences, healthcare, and regulated industries. They specialize in regulatory compliance, quality assurance, bioinformatics, data integrity, and electronic system buildouts, leading cross-functional development of Quality Management Systems (QMS), Business Continuity, and Disaster Recovery plans.
Laura has worked with organizations such as Inozyme Pharma, bioMérieux, Thermo Fisher | Patheon Biologics, and Washington University School of Medicine, driving enterprise-wide improvements with PMO development, regulatory remediation, software implementation, and IT service management.
As a consultant for BioEthica, they help organizations navigate complex regulatory landscapes, optimize systems, and drive sustainable growth through strategic, scalable solutions.
Ashley is a skilled scientific analyst who brings a wealth of knowledge in assay development and validation, specializing in immunoassays, biomarker assays, cell-based assays, and biochemical assays. She has significant experience in laboratory design and setup, equipment validation and calibration, QC/QA process mapping, workflow optimization, and SOP development.
Currently, she is expanding her expertise in project management as well as pharmacovigilance, focusing on regulatory compliance, case intake, and agency submissions.
In 2024, Ashley contributed to the scientific and medical research community by participating in the publishing of a research paper on the discovery of the overexpression of a specific DNA biomarker in relation to aggressive thyroid cancers, further demonstrating her commitment to advancing the field.
Strategic Advisors with Global Regulatory Insight
Dr. Hoffman has more than 35 years’ experience as a pharmaceutical physician in roles of increasing responsibility in Clinical Development, Medical Affairs and Pharmacovigilance. Prior to consulting with BioEthica has was in CMO roles for several small-to-midsize Pharma and CRO organizations.
He has significant clinical development program and life-cycle management experience (pre-IND-> NDA -> post-approval).
Dr Hoffman has significant project and policy experience at FDA and more than a dozen other Ministry of Health/ Regulatory Agencies globally.
With over 35 years of experience spanning regulatory leadership, pharmaceutical quality, and scientific innovation, Mr. Cruz is a seasoned expert in navigating complex compliance environments.
Following a distinguished 30-year tenure at the U.S. Food and Drug Administration, where he held senior leadership positions at CDER and the Emergency Operations Center, Coki advises life sciences organizations in matters of inspection readiness, regulatory strategy, and continuous improvement in pharmaceutical operations.
In addition to his consulting practice, ESCONDA Consulting Group, LLC, Coki serves on the Scientific Advisory Board of AiZen Algo Pvt. Ltd., supporting the integration of AI technologies into quality and productivity initiatives across the life sciences sector.
Gwyn Dickinson is a leading, former FDA expert with over 35 years of experience in regulatory inspections, audits, and quality systems across pharmaceuticals, biologics, medical devices, and veterinary products. A former Level-III Certified FDA Drug Investigator and Drug Specialist, she conducted high-risk inspections in the U.S. and internationally, evaluating complex manufacturing operations for compliance with cGMPs and regulatory submissions.
Since founding Dickinson Consulting, Inc. in 2011, Gwyn has performed over 200 audits, led mock FDA inspections, and provided strategic guidance on data integrity, investigations, CAPAs, and FDA expectations. Known for her ability to detect critical but often overlooked compliance issues, she offers practical, risk-based solutions to help companies navigate regulatory challenges. Gwyn is also a respected trainer and speaker, and holds a B.S. from California State University, Fullerton.
Shirley Berryman is a seasoned regulatory consultant with nearly four decades of experience in pharmaceutical compliance, inspections, and quality systems. With 30 years at the U.S. FDA, she held roles as Investigator, Compliance Officer, and Pre-Approval Manager, conducting inspections across a diverse range of industries, including drugs, biologics, medical devices, domestically and internationally.
Since 2015, Shirley has provided a broad array of audits and consulting services, including supply chain inspections, sterile Pre-Approval Inspections (PAIs), and remediation support for pharmaceutical manufacturers. Her consulting work spans the U.S., Europe, South Korea, and India, and covers various dosage forms and manufacturing operations. Shirley holds FDA Level III Drug Certification and Pharmaceutical Inspectorate and remains active in industry organizations like the Parenteral Drug Association (PDA) and Pharmaceutical Technical Exchange Association (PTEA).