Strategic Excellence Quality Consulting LLC
Transforming Quality Management Systems in Clinical Research, Pharmaceuticals, and Biotech for Excellence. Quality Assurance and compliance consultancy dedicated to value, research-driven solutions, and meeting client expectations.
15+ years of experience in Quality Assurance, Audits, and Compliance
American Society for Quality Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Quality Auditor (CQA)
Founder and Principal QA Consultant
Hello! I'm Sheena Scott, Founder and Principal QA Consultant, a dedicated and experienced Quality Assurance Leader.
Navigating clinical research, pharmaceuticals, and biotechnology can be challenging. I offer expertise in helping organizations maintain the highest standards in regulatory compliance and quality assurance. My consultancy aims to transform Quality Management Systems within these industries.
As Principal Consultant, I’m eager to partner with quality teams to conduct audits and risk assessments, uncover gaps, and lead projects that ensure regulatory compliance, audit readiness, and operational excellence.
Quality Management System and Compliance Solutions Tailored to Meet Your Unique Needs and Drive Operational Excellence
Quality Management System (QMS) Development and Optimization
- Develop and enhance Quality Management Systems (QMS) to align with GxP standards, focusing on streamlined processes, audit readiness, and regulatory compliance.
- Create and update SOPs, policies, and quality documentation to ensure they are practical, compliant, and sustainable.
GxP Auditing and Inspection Readiness
- Conduct GxP compliance audits for clinical sites, vendors, and internal processes, identifying gaps and ensuring adherence to FDA, EMA, ICH, and industry standards.
- Prepare clients for regulatory inspections with mock audits, readiness reviews, and tailored guidance on documentation and audit protocols.
Compliance Training and Staff Development
- Provide comprehensive training on GxP standards to clinical and laboratory operations teams, ensuring understanding of regulatory requirements.
- Develop role-specific training programs focused on risk management, documentation practices, and audit readiness to support a strong compliance culture.
Corrective and Preventative Action (CAPA) and Risk Management
- Implement and manage CAPA programs to address audit findings and compliance gaps effectively.
- Conduct risk assessments and develop mitigation strategies to proactively address compliance risks, fostering a culture of continuous improvement and quality.
Why Choose Me as Your Trusted Partner?
Approach to Consulting
My consulting approach focuses on strategic auditing, proactive risk management, and practical solutions tailored to each client's unique needs. I start by conducting a thorough assessment to identify gaps, then work closely with teams to develop corrective and preventative actions (CAPAs). I prioritize clarity and collaboration, ensuring that compliance procedures not only meet regulatory standards but also fit seamlessly into operational workflows.
Value and Impact
I add value by bringing a meticulous, research-driven approach to every project, ensuring that clients not only meet regulatory standards but exceed them where possible. My focus is on delivering practical, tailored solutions that align with each client's unique goals. I emphasize clear communication, proactive risk management, and a commitment to quality, which helps clients strengthen compliance, streamline operations, and improve audit outcomes. My goal is to make compliance a source of confidence rather than a challenge, contributing to a culture of excellence and reliability.
Dedication and Transparency
I am dedicated to providing clients with thorough, dependable quality and compliance solutions. I believe that transparency is key to building trust, so I communicate openly at every stage, keeping clients informed of progress, findings, and any challenges that may arise. My commitment to their success means I go the extra mile to ensure that solutions are not only compliant but also practical and sustainable. This approach helps foster strong, trusting partnerships and ensures that clients feel confident and supported through our work together.
Let's start addressing your quality and compliance needs together.
Reviews - Testimonals of Excellence from Clients
"I am pleased to write this recommendation for Sheena Scott, whom I had the privilege of working with when she was assigned to oversee the flow cytometry clinical data analysis for my team in 2019. From our first meeting, it was clear that Sheena brought extensive experience in regulatory compliance. She quickly demonstrated her aptitude by understanding our technology and collaborating effectively with my team to perform the QA review of the flow cytometry data.
Sheena’s role evolved over time as she took on the lead position for the Biomarker Quality Assurance (QA) program. In this capacity, she established robust quality metrics, which she presented quarterly at the Quality Council meetings. Her analytical skills were exceptional, and her recommendations contributed significantly to continuous improvements across four core biomarker laboratory technologies: Flow Cytometry, Ligand Binding Assays, LC/MS, and Molecular Genomics.In addition, Sheena was instrumental in developing a comprehensive quality manual for the biomarker laboratories. She also led mock inspections, preparing the team thoroughly for FDA and EMA audits and ensuring strict compliance with GxP guidelines.
Sheena effectively conducted numerous client audits, both virtual and on-site, always demonstrating professionalism in her communication and meticulous planning. She was prompt in responding to external auditors’ requests, accommodating their needs seamlessly.
I have great respect for Sheena’s work ethic and her ability to build positive interactions with my team and external auditors alike. I am confident that she will continue to excel and make a meaningful impact in her future endeavors."
Sheena’s role evolved over time as she took on the lead position for the Biomarker Quality Assurance (QA) program. In this capacity, she established robust quality metrics, which she presented quarterly at the Quality Council meetings. Her analytical skills were exceptional, and her recommendations contributed significantly to continuous improvements across four core biomarker laboratory technologies: Flow Cytometry, Ligand Binding Assays, LC/MS, and Molecular Genomics.In addition, Sheena was instrumental in developing a comprehensive quality manual for the biomarker laboratories. She also led mock inspections, preparing the team thoroughly for FDA and EMA audits and ensuring strict compliance with GxP guidelines.
Sheena effectively conducted numerous client audits, both virtual and on-site, always demonstrating professionalism in her communication and meticulous planning. She was prompt in responding to external auditors’ requests, accommodating their needs seamlessly.
I have great respect for Sheena’s work ethic and her ability to build positive interactions with my team and external auditors alike. I am confident that she will continue to excel and make a meaningful impact in her future endeavors."
Vellalore (K) N. Kakkanaiah
Retired - Director, Biomarker Lab at PPD Clinical Service, part of Thermo Fisher Scientific
"Sheena is true leader and expert in her field! I had the pleasure of working with Sheena on a QMS-focused project. Sheena was engaged and collaborative throughout the project and provided invaluable insight into GMP requirements and industry standards for laboratories. Sheena will be a great asset to any pharma or biotech company."
Tiara Brown-Crosen
GxP Compliance Expert | ex-FDA | Certified Quality Auditor | Quality Assurance | Pharmaceutical | Biotechnology | Clinical Research
"Thermo Fisher/PPD was a contract testing laboratory that my Client was seeking to obtain supplier approval for. I was contracted to perform a QA audit of the ThermoFisher/PPD facility located in Richmond, VA. Sheena was the QA Escort for this QA audit. Our Audit Agenda was agreed upon and the QA audit was conducted smoothly. Sheena was an excellent QA Host, providing answers to our numerous questions and responding to audit requests quickly. A comprehensive tour was provided by Sheena. Overall, a successful audit was conducted, completed, and my Client satisfied with the audit results. It was a pleasure to work with Sheena. She is professional, responsive, and works in a collaborative manner. I look forward to working with her on future projects."
Elaine Lee
Senior Consultant with Pharmtech Associates, a USP company
"I have been working with Sheena on Quality process improvements for the past year. She has been a valuable member of the team. I found her contributions meaningful to a complex project that challenged all levels within Quality."
Alona Michelle Waldrop-Kelly
GCP QMS Specialist CQA-ASQ
PPD, Thermo Fisher Clinical Research Group
"I had the pleasure of working within the same quality organization as Sheena for many years. Sheena was a constant leader in work ethic, communication skills, and effective organization of people and processes. Sheena and I worked together on two QMS improvement initiatives in 2024. Sheena arrived at meetings prepared and gave useful solutions which aligned multiple departments to a standardized process. Sheena is a natural leader with high character and people within our organization trusted her opinion and valued the work she consistently produced. I would highly recommend Sheena as a consultant; if I were a business owner looking to hire an employee right now I would interview Sheena."
Riley Parkinson
Associate Manager, Quality Assurance at PPD, part of Thermo Fisher Scientific
"I had the pleasure of working with Sheena Scott during her tenure as Associate Director, Quality Assurance, Client Audits and Regulatory Inspections/Archive at PPD a Part of Thermo Fisher Scientific. During this time, she consistently demonstrated exceptional expertise and leadership in quality management and audit and regulatory inspections in addition to contributing to the leadership of our Global BRG Mentorship program.Sheena Scott is an effective communicator and collaborator, building strong relationships with colleagues, clients, and stakeholders at all levels. Her inclusive and motivating leadership style fosters an environment where team members feel valued and inspired.Sheena Scott is a person of great integrity and dedication, and her work ethic and passion for excellence make her an invaluable asset to an organization. I wholeheartedly recommend her for any opportunity that leverages her outstanding quality management expertise."
Jennifer Paetzold, BA, MA, MS
Principal Learning Specialist
PPD, part of Thermo Fisher Scientific
Global BRG Mentorship Lead
Global Woman's Empowerment BRG
Communications Lead
Reviews - Testimonals of Excellence from Team
"Having worked under Sheena’s leadership in Quality Assurance, I can confidently say she set a high standard for what it means to be an inspiring, effective manager. With her years of experience in the field, Sheena not only brought deep expertise but also a genuine commitment to our team’s growth and success.
One example that stands out was when we were navigating a particularly complex audit. The pressure was high, and the requirements were shifting constantly. Instead of letting us feel overwhelmed, Sheena took the time to break down each step, ensuring that everyone knew their role and had the tools they needed. Her ability to keep us focused, calm, and on track was instrumental in our success. She turned what could have been a stressful situation into a learning experience, and I still carry those lessons with me today.
Sheena was also exceptional in making quality and compliance approachable. Whether we were reviewing a routine process or tackling a major project, she encouraged open dialogue and gave feedback that was constructive and empowering. I remember how Sheena would always take the time to explain the “why” behind our tasks, connecting our daily work to the bigger picture of patient safety and product integrity. This approach not only improved our processes but also instilled a shared sense of purpose among the team. In addition to her professional strengths, Sheena brought an element of humanity to the workplace that made our team feel genuinely valued. She would often remember the little things—whether it was asking about our weekends or celebrating team milestones—that helped foster a collaborative, positive environment.
I’m truly grateful to have had Sheena as a mentor and manager. Her leadership style and dedication left a lasting impact on me, and I’m confident they will continue to make a difference wherever they go."
One example that stands out was when we were navigating a particularly complex audit. The pressure was high, and the requirements were shifting constantly. Instead of letting us feel overwhelmed, Sheena took the time to break down each step, ensuring that everyone knew their role and had the tools they needed. Her ability to keep us focused, calm, and on track was instrumental in our success. She turned what could have been a stressful situation into a learning experience, and I still carry those lessons with me today.
Sheena was also exceptional in making quality and compliance approachable. Whether we were reviewing a routine process or tackling a major project, she encouraged open dialogue and gave feedback that was constructive and empowering. I remember how Sheena would always take the time to explain the “why” behind our tasks, connecting our daily work to the bigger picture of patient safety and product integrity. This approach not only improved our processes but also instilled a shared sense of purpose among the team. In addition to her professional strengths, Sheena brought an element of humanity to the workplace that made our team feel genuinely valued. She would often remember the little things—whether it was asking about our weekends or celebrating team milestones—that helped foster a collaborative, positive environment.
I’m truly grateful to have had Sheena as a mentor and manager. Her leadership style and dedication left a lasting impact on me, and I’m confident they will continue to make a difference wherever they go."
Vivek Jindal
Quality Assurance Auditor II
PPD, part of Thermo Fisher Scientific
"Sheena is an exceptional leader who fosters a supportive and collaborative team environment. Her clear, empathetic communication and strong team-building skills create a space where everyone feels comfortable contributing. As my mentor, she provided invaluable guidance in skill development and consistently prioritized my well-being, creating a safe space for open communication and support. Her dedication to fostering collaboration and mutual respect is truly remarkable."
Kelley Goncalves
Quality Assurance Auditor III
PPD, part of Thermo Fisher Scientific
"Sheena has an unwavering commitment to integrity and dedication to fostering a cooperative and supportive work environment. She is a skilled and knowledgeable leader who consistently works to strengthen relationships, creating a space where everyone feels respected. Her approachable, compassionate, and just demeanor makes her a pleasure to work with. She ensures every team member feels included and empowered. Her warmth and motivation inspires others to excel in challenging environments, and her genuine commitment to achieving successful outcomes builds trust and confidence in shared objectives. Sheena will be an asset to any team; bringing a blend of talent, dedication, and teamwork that consistently leads to positive results."
Brittany Borkowski MLS(ASCP) CM
Quality Assurance Auditor III
PPD, part of Thermo Fisher Scientific
"I have known and worked with Sheena Scott at ThermoFisher's Clinical Research Group/PPD for over five years, and for some of that time directly reported to her. Sheena is an outstanding people manager. She recognizes the unique potential and talent of each team member, and is committed to develop these to produce a highly effective team dynamic. She has a supportive and empathetic management style, and provides clear expectations with constructive feedback. Sheena walked the walk with our group, and her integrity and open communication fostered a culture of trust. I felt valued, consistently motivated and given opportunities to increase my skillset to benefit the team. I am extremely grateful for the guidance and mentorship she provided. As a result, I feel my professional development grew exponentially. I would not hesitate to endorse Sheena!"
Jacinda Power
Quality Assurance Auditor II at Thermo Fisher Scientific Clinical Research Group/ PPD
"I am pleased to recommend Sheena for her exceptional leadership and advocacy in our team. She has consistently supported our professional development, helping us become our best selves through guidance and encouragement. Her deep knowledge in the clinical research, QA/QC, compliance, and regulatory fields is evident in her strategic approach and insights, making her an invaluable resource. Additionally, her caring and understanding nature fosters a positive work environment where team members feel valued and motivated. Sheena is truly dedicated to our success, and her contributions have made a significant impact on our team.I am pleased to recommend Sheena for her exceptional leadership and advocacy in our team. She has consistently supported our professional development, helping us become our best selves through guidance and encouragement. Her deep knowledge in the clinical research, QA/QC, compliance, and regulatory fields is evident in her strategic approach and insights, making her an invaluable resource. Additionally, her caring and understanding nature fosters a positive work environment where team members feel valued and motivated. Sheena is truly dedicated to our success, and her contributions have made a significant impact on our team."
Rana Haboush
QA Coordinator at PPD part of Thermo Fisher Scientific
Additional reviews and recommendations can be found on LinkedIn: www.linkedin.com/in/sns314