Daniel Burgess, Frqa Email and Phone Number
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Daniel W Burgess is a strategic executive and servant quality assurance leader within the pharmaceutical quality industry. Bringing deep knowledge while maintaining a hands-on approach to engage high-functioning groups through successful research, approval and commercialization of products, most recently Ohtuvayre with Verona Pharma.Driving the growth of compliant quality management systems for the global pharmaceutical, medical device and biologics industries. Encompassing toxicology, laboratory, clinical research, manufacturing and commercial activity within both small and large companies; across multiple regulated industries: active pharmaceutical ingredients and drug product; sterile and non-sterile; IV, inhalation and oral. (GLP, GCLP, GCP, GMP, GDP, GVP)Daniel W Burgess brings a unique mix of visionary, strategic, operations and analytical expertise to create immediate impact, consistently exceeding revenue and performance goals by aligning staff talents and effort with organizational objectives. "Executives must be leaders, not just sponsors. With limited bandwidth, we must ask ourselves what is most important, right now. This singular focus unifies leader, team, and organization. By defining the critical strategic initiative for any given period of time, we avoid overwhelming with change that cannot be effectively conceived or implemented.""My objective is to impact long term root causes and industry challenges, to evolve quality assurance beyond a classical audit and CAPA cycle to demonstrate risk-based effectiveness from discovery through commercialization."Holding progressive leadership roles within contract research and pharmaceutical industry organizations, each achieving improved outcomes. Qualified with a bachelor’s degree from the University of South Wales, UK and further qualifications in ISO, audit and instructional design. A graduate from the RQA Diploma in Research Quality Assurance in 1995 and author of the IAOCR certified Audit Academy in 2020, recognized by peers as a Fellow in Research Quality Assurance (FRQA). A speaker and tutor for international quality associations and previous editor of the industry magazine 'Quasar'. Building effective quality management systems and SOP structures, an advocate of people development, continuous improvement and transparency, regarded as a compliant end-point focused innovator. He brings a unique approach, joy, and vision to 'living' compliance.
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Senior Director, QualityAerogen PharmaChapel Hill, Nc, Us
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FounderQairc Oct 2020 - PresentQAIRC was founded help small to mid-sized, highly regulated companies to simplify and enhance Quality Assurance, Inspection Readiness and Communication. Right sizing quality systems to ensure inspection readiness in a phase appropriate manner, providing cost effective compliance solutions, discovery through approval.• Building a collaborative culture of quality and continuous improvement initiatives to maintain centralized quality methodologies. Aid understanding through untangling policies and procedures.• Establish effective quality management, selecting and implementing supportive eQMS • Leading strategy, annual tactical planning and reporting activities. Providing QA clarity to focus on what matters• Keeping teams up to date with regulations and standards, including ISO, ICH, FDA across the GxPs, and assuring uptake in procedures• Building and training quality teams, ensuring training standards are current, certified and maintained• Implementing audit programs, including standard work for inspection readiness and success• Leading inspections, meetings, and visits, representing senior leadership whenever needed or appropriate -
Vice President, Quality AssuranceVerona Pharma Dec 2022 - Oct 2024London, Uk, GbLead and worked alongside four direct reports, provided vision and leadership to the company’s quality thinking in bringing Ohtuvayre (Ensifentrine) to the US market. Ensuring Verona Pharma’s network of CROs and CDMOs worked together for success.• Lead Verona Pharma through successful inspections for the approval of their first product• Established GCP QA and clinical auditing strategy, managing trial specific programs across multiple indications• Built clinical inspection readiness program, providing visual systems maps for sponsor and sites to communicate risks• Brought efficiency to quality management through implementation of eQMS, establishing metrics that matter• Streamlined Policy/ SOP timelines, authorship and organization• Enhanced learning curricula, always maintaining training at >95% throughout the business• Created user friendly workflows in CAPA, change control and issues management• Oversaw global supplier network encompassing development to commercial requirements, providing risk-based qualification, audit program and quality technical agreement requirements• Ensured common practice standards within QA across; GCP, GCLP, GMP, GLP, GVP and GDP• Personally auditing, overseeing initial production and drug disposition for API and drug product and providing GMP QA input on second source API and DP CDMOs; travelling approximately 50% of the time -
Senior Director, Global Clinical Quality Assurance, Systems And ComplianceNovavax Inc Jun 2021 - Dec 2022Gaithersburg, Maryland, UsServing through the global pandemic, developing a nimble quality team for global clinical and pharmacovigilance oversight. Successfully bringing Novavax COVID-19 Vaccine to the global market with five reports.• Drove continuous improvement through risk-based quality strategy. Provided clinical (GCP) and pharmacovigilance (GVP) quality vision in tactical audit of systems, suppliers, affiliates, and partners• Demonstrated effectiveness through numerous successful regulatory GCP and GVP inspections, including MHRA (UK), EMA (EEA), FDA (USA), PMDA (Japan), TGA (Australia), and MFDS (South Korea) Winning “Rockstar Award” for ethics as quality subject matter expert for global inspections• Developed audit team and auditors’ capabilities from ‘initial traction’ through ‘sustainable high growth’• Defined and implemented a quantitative approach to strategic and tactical planning; maturity measures and KPIs that ‘keep people interested’, cascade oversight through the supply chain, and provided risk awareness • Facilitated clinical immunology laboratory (GCLP) certification -
Editorial Board MemberPolicy & Medicine Compliance Update (Formerly Lscu) Jan 2018 - Dec 2022Columbia, Maryland, UsPolicy & Medicine offers a daily look at legal, regulatory, and compliance issues affecting the pharmaceutical and device industry. Since its inception in 2008, Policy & Medicine has become one of the most widely followed websites in its field. Policy & Medicine provides detailed analysis of many important compliance issues, and is one of the leading resources for information on the Physician Payments Sunshine Act and transparency issues. Policy and Medicine has been quoted by hundreds of news sources including, CNN, NY Times, ABC News, and Wall Street Journal. -
Chief Compliance Officer, Vp Quality AssurancePharm-Olam, Llc Oct 2016 - Oct 2020Houston, Tx, UsReporting directly to CEO and Board, provided advanced business knowledge, general management, and quality leadership within a fast-paced work environment. Provided global quality vision for over 600 staff and 13 reports, leading, customer focused, mid-sized CRO, operating in over 60 countries, and 25 offices.• Lead; Quality Systems, SOPs, Global Audit, Inspection Readiness, Validation, Privacy (GDPR) and Organizational Training• Planned, budgeted, and delivered cross functional growth including 200% Quality Assurance growth with demonstrable return on investments (ROI) for process improvements• Established and maintained an effective cross functional global leadership team• Ensured effective issues communication and training was in place across all global facilities• Authored and delivering GCP “Audit Academy” an IAOCR certified training program with over 50 graduates• Established the organizations first electronic quality management system (eQMS), developing unique risk-based SOPs under ICH (E6) R2 (2018) incorporating active risk through CAPA status• Directed, coordinated, and tracked QA team's efforts, ensuring milestones were met within defined budgets and schedules• Winner CRO Leadership Awards for Quality 2017, 2019, 2020Delivered on the vision to provide revenue and cost savings through compliance activities, reducing waste by building effectiveness into procedures and training, examining ‘the cost of quality’. A critical element was building a new foundation of visual, risk based SOPs and auditor training, improving audit standards and improving quality down through supplier network. -
Senior Director, Corporate ComplianceHospira, A Pfizer Company May 2013 - Oct 2016New York, New York, UsDirected corporate (GMP) manufacturing audit across 18 facilities for the world leader in specialty generic injectable pharmaceuticals, with a team of 11 reports.• Provided and presented regular reports to CEO and board in support of GMP compliance activities globally• Set objectives, implementing strategic, tactical, and operational audit programs while engaging to support foundational SOP structures• Lead from the front, for approximately 18 international GMP audits per year, while planning and facilitating the overall audit program• Providing audit intelligence to manage all 14 facilities into compliance, OIA or VIA to NAI, leading to Pfizer acquisition• Successfully rebuilt audit teams and success up to Pfizer’s acquisition, with the goal of “No Surprises”. and integration of processes with Pfizer systems afterwards. • Audit Community of Practice’, bringing global internal auditors together, each sharing passion for continuous improvement and growth. Providing career opportunities and cross training• Advanced preparedness across pharmaceutical, biopharmaceutical and device sites for regulatory audit, assisting in the facilitation of positive compliance movement and measuring effectiveness of corrective and preventative actions (CAPA)• A culture of accountability, personally leading high risk and critical audits from the front, traveling globally approximately 50% of the time -
Director Of Quality Assurance And Regulatory AffairsThermo Fisher Scientific 2011 - 2013Waltham, Ma, UsDirected collaborative growth for industry leader in the management of critical biological materials to support advancement of cell therapies, GMP biologics, and population based public health research. Expanding organizational quality and training systems for cold chain management with 25 reports.• Lead the functions of Internal and Supplier Audit, Training and Validation (equipment and shipping lanes), to clinical, manufacturing and distribution (GDP) standards• Developed ‘Metrics that Matter’ key performance indicators to facilitate leadership in ‘Practical Process Improvement’ for greater process efficiencies.• Audited internal systems and suppliers for ongoing regulatory compliance• Demonstrated ROI from quality systems through measured reduction in risk and with successful customer audits and regulatory inspections -
Global Head, Clinical Quality AssuranceAlexion Pharmaceuticals 2009 - 2010Boston, Massachusetts, UsLead (GCP) clinical and (GVP) pharmacovigilance Quality Assurance. Responsible for initial development and implementation of global quality management system and auditing programs to initial commercialization.• Established US, Swiss and Japan QA operations, with successful regulatory inspections• Defined and conducted audits under global clinical audit program• Winner: 2009 RQA Premier Article, “Innovation in the development of SOPs”• Hosted international clinical and pharmacovigilance regulatory inspections for launch of new product: PMDA, MHRA, EMA and FDA -
Director, Quality Standards And Medical EducationPfizer 1998 - 2008New York, New York, UsDeveloped clinical audit capabilities within the World’s leading pharmaceutical company under new foundational (GCP) clinical regulations ICH E6 (R1) (1997)• Directed UK Clinical Quality: Audit, SOPs, establishing quality management system (eQMS) under developing 2001/20/EC onwards, incorporating Good Clinical Laboratory Practice (GCLP) with its establishment in 2003• Provided management and mentoring processes for 26 EU staff and a local UK team of five• Lead Auditor, coordinating European QA communications and programs, responsible for leading Pfizer’s European audit teams and training a team of 80 Pfizer auditors globally• Relocated to USA to lead clinical auditor training and medical education globally• Winner: Pfizer awards in mentorship, communication, and innovation; New York Design award for curricula; RQA distinction, marked by exceptional and significant contribution• Expanded to enhance global medical training programs, establishing competitive investigator grants across cardiovascular, respiratory, urological, and oncological health• Lead project teams of up to 30 staff assuring compliance of Medical and Regulatory operations; performing international audits for systems, sites, vendors, including review of IND and MAA filings, sales, marketing, R&D• Collaborated with key opinion leaders to design, manage and deliver investigator education• Managed a team for transition of CME grants to ACME standards. Ensured program integrity and developed quality control systems for grant management in compliance with regulation. i.e. Sunshine Act, FCPA, and others• Editor of “Synapse” in-house magazine, increased requests for circulation by 500%• Editor of “Quasar” for The Research Quality Association (RQA)
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International AuditorNovartis 1996 - 1998Basel, Baselstadt, ChWorldwide coverage of all areas of the Novartis pharmaceutical activities, assuring corporate management of the compliance of research. Planned, conducted and reported on GxP audits for processes, systems, investigational sites, laboratories and contractors. Lectured nationally in the audit of computerized systems, the use of computerized audit tools and quality systems within a regulatory environment, a key member in the coordinated national review of 21CFR11.Solidified ISO knowledge graduating as ISO9000 Lead Auditor in 1998 -
Quality Assurance And Compliance Officer (Medical)Ipsen International 1994 - 1996Boulogne Billancourt, FrProvided system and investigational GCP site audit coverage of UK activities and support of world-wide QA activities of the Beaufour-Ipsen group. Established further expertise in ISO9000 and TQM.Graduated in The Research Quality Association (RQA) Diploma in Research Quality Assurance through the University of Cambridge at Downing College. -
Senior Quality Assurance Auditor/ Training Co-OrdinatorPpd 1989 - 1994Wilmington, Nc, UsFast track employee, starting career as laboratory manager and moving to develop capabilities in GLP QA team. With establishment of ICH E6 (R1) expanding into provision of GCP services: inspection of procedures; audit of data; review of reports and external audit, both within the corporate structure and for contracting sponsors. Active member of the British Association of Research Quality Assurance (BARQA), now The Research Quality Association (RQA) Computing Committee. Assisted in facilitation of ISO9001 certification of sitePharmaco-LSR (Pharmaco-LSR, Inc.) has merged with PPD (Pharmaceutical Product Development Company) and is now part of Thermo Fisher Scientific
Daniel Burgess, Frqa Skills
Daniel Burgess, Frqa Education Details
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University Of CambridgeGxp -
University Of South WalesGeneral
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Bay House, Gosport
Frequently Asked Questions about Daniel Burgess, Frqa
What company does Daniel Burgess, Frqa work for?
Daniel Burgess, Frqa works for Aerogen Pharma
What is Daniel Burgess, Frqa's role at the current company?
Daniel Burgess, Frqa's current role is Senior Director, Quality.
What is Daniel Burgess, Frqa's email address?
Daniel Burgess, Frqa's email address is da****@****zer.com
What schools did Daniel Burgess, Frqa attend?
Daniel Burgess, Frqa attended University Of Cambridge, University Of South Wales, Bay House, Gosport.
What skills is Daniel Burgess, Frqa known for?
Daniel Burgess, Frqa has skills like Fda, Pharmaceutical Industry, Gmp, Regulatory Affairs, Gcp, Clinical Trials, Validation, Quality Assurance, Quality System, Oncology, Quality Auditing, Auditing.
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