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With over 30 years of expertise in FDA-regulated industries, Robert (Bob) Lawrence has become a trusted leader in pharmaceutical and biotechnology compliance. As the President and Senior Quality SME at Quality Administrative Associates, LLC, Bob has helped countless companies navigate complex regulatory landscapes, ensuring their projects stay on track, on budget, and in full compliance.
Throughout his career, Bob has held pivotal roles including Project Manager, Director, Vice President, and President at leading regulatory compliance consulting firms. His international and domestic experience has made him a go-to individual, known for managing small projects to multi-million-dollar projects and creating environments where both clients and colleagues thrive.
Bob’s vision for Quality Administrative Associates is clear: to continue delivering exceptional consulting services that build long-lasting relationships with clients. Backed by a team of industry recognized professionals and rising stars, Bob ensures that each client receives personalized, high-quality solutions to meet their compliance goals.
Outside of work, Bob enjoys spending time with his family, friends, and his dog.
During 2023 the company underwent new branding with a new vision and direction for the company’s future. QAA brings a consortium of senior level associates/consultants experienced in meeting regulatory compliance. All of the associates and consultants have the common goal of providing the right level of knowledge and expertise to support our client’s compliance initiatives. It is a core belief of our associates and consultants to achieve the highest level of safety and quality in our client’s products using a risk-based approach to compliance.
When our clients succeed, we succeed and by establishing long-lasting relationships based on transparency, trust, knowledge, performance, experience and accountability we continue to develop proven compliance solutions for our clients.
QAA partners with various companies that provide additional services to regulated industries including the following.
Our Senior Associates have been in the industry on an average of 25 years offering a broad range of technology and industry experience including Pharmaceutical, Biotech, Medical Device, Animal Health, Nutraceuticals, Cosmetics/Personal Care, Food, Tobacco and Cannabis industries. QAA will provide single resource, fractional resources, staff augmentation, or an entire team to meet our client’s needs. Our flexibility allows for quick deployment to meet our client’s requirements.
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As the President and Senior Quality SME at Quality Administrative Associates, LLC, Bob has helped countless companies navigate complex regulatory landscapes, ensuring their projects stay on track, on budget, and in full compliance. Throughout his distinguished career, Bob has held pivotal roles including Project Manager, Director, Vice President, and President at leading regulatory compliance consulting firms. His international and domestic experience has made him a go-to individual, known for managing small projects to multi-million-dollar projects and creating environments where both clients and colleagues thrive.
Bob’s vision for Quality Administrative Associates is clear: to continue delivering exceptional consulting services that build long-lasting relationships with clients. Backed by a team of industry recognized professionals and rising stars, Bob ensures that each client receives personalized, high-quality solutions to meet their compliance goals.
Outside of work, Bob enjoys spending time with his family, friends, and his dog.
Doug has worked with companies domestically and internationally in Over The Counter and Prescription Drug manufacturing. He has provided:
• Project lead for Initial facility start-up qualifications – facilities, utilities, equipment
• Conducted facilities, utilities, and equipment qualification
• Conducted Technical Transfer of products out of and into companies
• Evaluations of proposed contract manufacturers
• Review of validated processes and batch records
• Developed and executed Process Performance Validation
• Worked with Oral Solid Dosage, Liquids, and Semi-Solids
• Qualified an Alcohol distillation company to meet FDA requirements
Doug’s international and domestic experience has made him a go-to individual, known for creative solutions to complex problems while always ensuring that the client and colleagues thrive. His main goal for any client is that they receive the best solution possible to meet their compliance goals
Outside of work, Doug enjoys traveling, spending time with his family and friends, and his dog.
GCP-compliant phase I-IV clinical trials for pharma, biopharma, medical devices, and med tech. I am experienced in
improving the efficiency and effectiveness of operations and creating scalable, cost-efficient GxP technology
strategies. I perform supplier quality management and qualification audits. I provide GLP, GCP, GMP, and GVP training
and audits. Additionally, I can help with ISO 9001 and ISO 13485 certification audits and preparation.
Years of Experience: 25+ years
Education & Certifications:
B.S., Chemistry, Biology
Lean Six Sigma Master Black Belt
CMQOE (ASQ)
RAC (Global Biologics, Drugs, Medical Devices)
Broad base of experiences in quality control, quality assurance, manufacturing, technical services/process development, validation, and project management. Experience working in multiple therapeutic categories with large and small molecules, biologics, proteins, and biodegradable polymers for parenteral, intranasal, subcutaneous, topical, oral solid and oral liquid delivery systems. Experience working with small start-ups and large multinationals and using strategies and approaches right for each client’s specific needs.
Unique enjoyment of difficult, complex, and challenging projects
Lifelong learner and continuous improver
Project Management Certificate Program, Western Kentucky University, 2018
M.B.A., Indiana Wesleyan University, 2007
B.S., Chemistry-Forensic Science, Eastern Kentucky University, 1995
B.A., Biology, Transylvania University, 1993
Member: Regulatory Affairs Professional Society (RAPS)
experience working in the pharmaceutical, biological, biotech, animal health and quality control industries. Mike can develop and qualify protocols at all levels incorporating broad-based experience and strong knowledge of GMP’s and FDA regulations. Mike is skillful at problem solving and process flow analysis leading to successful resolution of problematic issues. He has prepared entire life-cycle validation documentation from user requirements through process validation. Experienced in developing strategic documentation like Validation Master Plans, Design Specifications, User Requirements, Qualification and Validation protocols. Mike has also performed a wide range of deviation investigations and developed corrective actions and preventative actions to support clients quality goals.
meeting the regulatory requirements for the regulated industries of the FDA and EUMDR. In the areas of Qualification as well as Product and Process Validation, Cleaning Validation, and meeting remediation requirements
Jon has been involved in the validation of some of the world’s best known pharmaceutical and medical device company’s products, utilizing his strong background with Design Engineering, Validation, Process and Performance Qualification, Citation Remediation, Regulatory Compliance, and Quality Assurance in the Manufacturing side as well as the Quality and R&D / QC side, with a strong aptitude in robotics and automation.
Jon has provided consistent demonstrated performance on Managing and leading, and he possesses a high-level of analytical problem-solving skills and knowledgeable engineering experience in complex multi-faceted systems
training, Bryan specializes in creating impactful training policies, and content implementing Learning Management Systems, and developing comprehensive training and development programs across multiple disciplines and companies. His approach as an interactive trainer combines unique instructional design with strong communication skills, ensuring that learning is not just a one-time event, but a continuous, culture-integrated process.”. The goal is to build a training foundation that empowers every individual to recognize and believe in their growth within their company.
Skilled in preparing and reviewing FDA submissions and annual reports, QC, Technical Services, Product Development and Process Validation. Leading cross-functional teams Lisa has demonstrated her capabilities of bringing teams together to achieve the highest level of quality to multiple organizations and products. Lisa is in the process of completing Master of Science (MS) in Pharmaceutical Manufacturing and holds BS of Science.
Senior Regulatory & Quality Associate
Proven leader and technical professional with over 24 years of experience in the pharmaceutical industry. Broad base of experiences in quality control, quality assurance, manufacturing, technical services/process development, validation, and project management. Experience working in multiple therapeutic categories with large and small molecules, biologics, proteins, and biodegradable polymers for parenteral, intranasal, subcutaneous, topical, oral solid and oral liquid delivery systems. Experience working with small start-ups and large multinationals and using strategies and approaches right for each client’s specific needs.
Senior Quality Associate
With over 30 plus years of experience providing validation, manufacturing, research & development and quality experience working in the pharmaceutical, biological, biotech, animal health and quality control industries. Mike can develop and qualify protocols at all levels incorporating broad-based experience and strong knowledge of GMP’s and FDA regulations. Mike is skillful at problem solving and process flow analysis leading to successful resolution of problematic issues. He has prepared entire life-cycle validation documentation from user requirements through process validation. Experienced in developing strategic documentation like Validation Master Plans, Design Specifications, User Requirements, Qualification and Validation protocols. Mike has also performed a wide range of deviation investigations and developed corrective actions and preventative actions to support clients quality goals.
Senior Quality Associate
With over 33 years of Pharmaceutical, Medical device, and Industrial chemical experience, Jon specializes in meeting the regulatory requirements for the regulated industries of the FDA and EUMDR. In the areas of Qualification as well as Product and Process Validation, Cleaning Validation, and meeting remediation requirements
Jon has been involved in the validation of some of the world’s best known pharmaceutical and medical device company’s products, utilizing his strong background with Design Engineering, Validation, Process and Performance Qualification, Citation Remediation, Regulatory Compliance, and Quality Assurance in the Manufacturing side as well as the Quality and R&D / QC side, with a strong aptitude in robotics and automation.
Jon has provided consistent demonstrated performance on Managing and leading, and he possesses a high-level of analytical problem-solving skills and knowledgeable engineering experience in complex multi-faceted systems
Senior Training & Quality Associate
With over 22 years of experience in the pharmaceutical industry and nearly two decades of experience dedicated to training, Bryan specializes in creating impactful training policies, and content implementing Learning Management Systems, and developing comprehensive training and development programs across multiple disciplines and companies. His approach as an interactive trainer combines unique instructional design with strong communication skills, ensuring that learning is not just a one-time event, but a continuous, culture-integrated process.”. The goal is to build a training foundation that empowers every individual to recognize and believe in their growth within their company.
With over 33 years of Pharmaceutical, Medical device, and Industrial chemical experience, Jon specializes in meeting the regulatory requirements for the regulated industries of the FDA and EUMDR. In the areas of Qualification as well as Product and Process Validation, Cleaning Validation, and meeting remediation requirements
Jon has been involved in the validation of some of the world’s best known pharmaceutical and medical device company’s products, utilizing his strong background with Design Engineering, Validation, Process and Performance Qualification, Citation Remediation, Regulatory Compliance, and Quality Assurance in the Manufacturing side as well as the Quality and R&D / QC side, with a strong aptitude in robotics and automation.
Jon has provided consistent demonstrated performance on Managing and leading, and he possesses a high-level of analytical problem-solving skills and knowledgeable engineering experience in complex multi-faceted systems
With over 22 years of experience in the pharmaceutical industry and nearly two decades of experience dedicated to training, Bryan specializes in creating impactful training policies, and content implementing Learning Management Systems, and developing comprehensive training and development programs across multiple disciplines and companies. His approach as an interactive trainer combines unique instructional design with strong communication skills, ensuring that learning is not just a one-time event, but a continuous, culture-integrated process.”. The goal is to build a training foundation that empowers every individual to recognize and believe in their growth within their company.
With over 22 years of experience in the pharmaceutical industry and nearly two decades of experience dedicated to training, Bryan specializes in creating impactful training policies, and content implementing Learning Management Systems, and developing comprehensive training and development programs across multiple disciplines and companies. His approach as an interactive trainer combines unique instructional design with strong communication skills, ensuring that learning is not just a one-time event, but a continuous, culture-integrated process.”. The goal is to build a training foundation that empowers every individual to recognize and believe in their growth within their company.
Lisa is a Pharmaceutical Regulatory Affairs professional with 24 years of experience. Skilled in preparing and reviewing FDA submissions and annual reports, QC, Technical Services, Product Development and Process Validation. Leading cross-functional teams Lisa has demonstrated her capabilities of bringing teams together to achieve the highest level of quality to multiple organizations and products. Lisa is in the process of completing Master of Science (MS) in Pharmaceutical Manufacturing and holds BS of Science.
Proven leader and technical professional with over 24 years of experience in the pharmaceutical industry. Broad base of experiences in quality control, quality assurance, manufacturing, technical services/process development, validation, and project management. Experience working in multiple therapeutic categories with large and small molecules, biologics, proteins, and biodegradable polymers for parenteral, intranasal, subcutaneous, topical, oral solid and oral liquid delivery systems. Experience working with small start-ups and large multinationals and using strategies and approaches right for each client’s specific needs.
With over 25 years of experience as a Quality and Regulatory Compliance Expert, I have been a leader, mentor, and coach for teams and individuals focused on clinical research, clinical operations, site quality, inspection readiness, and GCP-compliant phase I-IV clinical trials for pharma, biopharma, medical devices, and med tech. I am experienced in improving the efficiency and effectiveness of operations and creating scalable, cost-efficient GxP technology strategies. I perform supplier quality management and qualification audits. I provide GLP, GCP, GMP, and GVP training and audits. Additionally, I can help with ISO 9001 and ISO 13485 certification audits and preparation.
I am a Lean Six Sigma Master Black Belt, recognized for my exceptional problem-solving skills, ability to execute projects accurately the first time, and delivering outstanding results. I possess a unique ability to think beyond the immediate scenario to develop scalable, compliant solutions. My expertise lies in data analysis, listening, motivating cross-functional teams, and using innovation to tackle complex business challenges.
With over 30 years of expertise in FDA-regulated industries, Robert (Bob) Lawrence has become a trusted leader in pharmaceutical and biotechnology compliance. As the President and Senior Quality SME at Quality Administrative Associates, LLC, Bob has helped countless companies navigate complex regulatory landscapes, ensuring their projects stay on track, on budget, and in full compliance.
Throughout his distinguished career, Bob has held pivotal roles including Project Manager, Director, Vice President, and President at leading regulatory compliance consulting firms. His international and domestic experience has made him a go-to individual, known for managing small projects to multi-million-dollar projects and creating environments where both clients and colleagues thrive.
Bob’s vision for Quality Administrative Associates is clear: to continue delivering exceptional consulting services that build long-lasting relationships with clients. Backed by a team of industry recognized professionals and rising stars, Bob ensures that each client receives personalized, high-quality solutions to meet their compliance goals.
Outside of work, Bob enjoys spending time with his family, friends, and his dog.
President/Senior Quality Associate With over 30 years of expertise in FDA-regulated industries, Robert (Bob) Lawrence has become a trusted leader in pharmaceutical and biotechnology compliance. As the President and Senior Quality SME at Quality Administrative Associates, LLC, Bob has helped countless companies navigate complex regulatory landscapes, ensuring their projects stay on track, on budget, and in full compliance. Throughout his distinguished career, Bob has held pivotal roles including Project Manager, Director, Vice President, and President at leading regulatory compliance consulting firms. His international and domestic experience has made him a go-to individual, known for managing small projects to multi-million-dollar projects and creating environments where both clients and colleagues thrive. Bob’s vision for Quality Administrative Associates is clear: to continue delivering exceptional consulting services that build long-lasting relationships with clients. Backed by a team of industry recognized professionals and rising stars, Bob ensures that each client receives personalized, high-quality solutions to meet their compliance goals. Outside of work, Bob enjoys spending time with his family, friends, and his dog.
Senior Quality Associate
Senior Quality/Regulatory Associate
Senior Training Associate
info@qualityadministrative.com
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Cincinnati, OH 45241
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