Sheila Johnson

QA Director for a start-up CRO that developed SOPs and Policies. Implemented a QMS system. Planned, conducted, and reported various audits for clinical sites, vendors, labs, pharmacovigilance, Computer systems, and any additional assessments needed. A yearly audit plan and schedule was written for the company and maintained.

• Assured consistent quality of production by implementing and enforcing automated practice systems.
• Monitored staff organization and suggested improvements to daily functionality.
• Collaborated with cross-functional teams to develop and implement process and system improvements.
• Created and maintained quality management systems to align with industry standards.
• Investigated customer complaints and performed corrective actions to resolve quality issues.
• Assessed product quality by monitoring quality assurance metrics, reports and dashboards.
• Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
• Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
• Conducted risk assessments to identify and mitigate potential quality issues.
• Performed root cause analysis to identify and resolve quality issues and defects.
• Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production.
• Tracked quality issues with external customers, suppliers, and internal plant operations.
• Established and tracked quality department goals and objectives.
• Determined quality department standards, practices, and procedures.
• Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
• Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.

• Developed and implemented quality assurance protocols to ensure product consistency and reliability.
• Ensured compliance with industry standards such as ISO 9001, ICH GCPs, all device regulations while developing test cases and executing tests.
• Collaborates on SOP updates ensuring ISO 9001, ISO 13485, ICH-GCP, and FDA compliance.
• Conducted and reported internal/external GxP audits to maintain high-quality clinical research.
• Advised on FDA regulations, providing clear guidance on Quality Systems and SOPs.
• Managed CAPAs, evaluating their effectiveness to ensure continuous improvement.
• Trained staff on GxP procedures, enhancing overall compliance knowledge.
• Was a point of contact for all regulation matters.
• Utilized problem solving skills to isolate issues, determine root cause of problems and develop effective solutions.
• Identified opportunities for automation within the existing QA process through research into new technologies.
• Provided technical support when needed during customer acceptance tests and post-release maintenance cycles.
• Collaborated closely with developers in troubleshooting application issues during the QA process.
• Contributed towards improving the overall efficiency and effectiveness of QA processes through regular review and analysis.
• Communicated and corresponded with customers and suppliers regarding quality issues, problems and complaints.
• Conducted in-house inspections to verify compliance to quality programs and processes.
• Updated standard operating procedures and quality assurance manuals.

• Documented all audit findings and prepared detailed reports for management review.
• Maintained accurate records of audit work papers for future reference.
• Evaluated compliance with corporate policies and procedures, as well as external regulations.
• Prepared audit reports and provided recommendations for process improvements to ensure compliance with corporate policies.
• Maintained compliance with auditing standards, regulations, and best practices in all audit activities.
• Collaborated with cross-functional teams to develop and implement corrective action plans in response to audit findings.
• Monitored and tracked the status of audit findings and corrective actions to ensure timely resolution.
• Conducted special audits and investigations in response to allegations of fraud, misconduct, or irregularities.
• Examined whether organization's objectives were reflected in its management activities and whether employees understand objectives.
• Collected and analyzed data to detect deficient controls, duplicated effort, and extravagance.
• Supervised auditing of establishments and determined scope of investigation required.
• Determined if systems and programs under development will work as planned.
• Prepared periodic reports to compare budgeted costs to actual costs.
• Conducted Various GxP audits for clinical research and vendors.

• Provided guidance on coding best practices to ensure high-quality code is delivered with minimal defects.
• Identified opportunities for automation within the existing QA process through research into new technologies.
• Developed and implemented quality assurance protocols to ensure product consistency and reliability.
• Utilized problem solving skills to isolate issues, determine root cause of problems and develop effective solutions.
• Collaborated closely with developers in troubleshooting application issues during the QA process.
• Contributed towards improving the overall efficiency and effectiveness of QA processes through regular review and analysis.
• Conducted various internal/external audits for regulatory compliance.
• Conducted TPV assessments.

• Documented all audit findings and prepared detailed reports for management review.
• Maintained accurate records of audit work papers for future reference.
• Evaluated compliance with corporate policies and procedures, as well as external regulations.
• Prepared audit reports and provided recommendations for process improvements to ensure compliance with corporate policies.
• Performed follow-up reviews on previously identified issues to ensure corrective action was taken.
• Trained staff on proper accounting principles, methods, techniques and procedures.
• Maintained compliance with auditing standards, regulations, and best practices in all audit activities.
• Conducted special audits and investigations in response to allegations of fraud, misconduct, or irregularities.
• Collaborated with cross-functional teams to develop and implement corrective action plans in response to audit findings.
• Contributed to success of audit engagements by exceeding expectations and delivering valuable insights to clients.
• Communicated audit results and recommendations to stakeholders, including senior management and regulatory authorities.
• Implemented comprehensive audit procedures to assess effectiveness of internal controls and risk management systems.
• Prepared detailed reports on audit findings.

• Reviewed accounting records to verify accuracy of client information and identify discrepancies or weaknesses in internal controls.
• Conducted interviews with clients' personnel to obtain an understanding of their operations, policies, procedures, objectives, strategies, and related internal controls.
• Developed risk assessments based on analysis of industry trends and changes in business environment.
• Coordinated with external auditors when required by regulatory agencies or other third parties.
• Evaluated operational effectiveness by analyzing business processes using flowcharts and narratives as well as interviewing personnel at all levels within the organization.
• Developed audit plans to assess the adequacy of internal controls and compliance with applicable laws and regulations.
• Provided technical advice regarding Generally Accepted Accounting Principles issues encountered during fieldwork.
• Assisted in developing new auditing standards for the firm's practice group.
• Designed test programs to evaluate the reliability of computerized systems used by clients.
• Trained junior staff members on various aspects of auditing techniques.
• Created a system for tracking progress against established audit objectives.
• Developed relationships with clients that resulted in increased revenue for the firm.
• Prepared detailed reports on audit findings for senior-level management review.
• Remained current on professional developments related to auditing standards and best practices.
• Maintained effective communication with clients throughout the engagement process.
• Developed and prepared detailed reports on audit findings.
• Determined if systems and programs under development will work as planned.
• Prepared detailed reports on audit findings.

• Trained new employees in product knowledge, customer service protocols, cash handling procedures, and safety regulations.
• Resolved customer complaints quickly and effectively while maintaining a high level of professionalism.
• Helped oversee the daily operations of managing staff.
• Managed and maintained a QMS system for document management, audit management, and CAPA management.
• Performed various GxP audits throughout the organization both internally and externally.
• Worked with Data Management to produce reports for consistency checks.
• Produced reports for Management review and quarterly meetings.

• Gxp Principal Auditor. Worked effectively as part of a team and Independently. Was able to meet deadlines.
• Developed Quality Plans.
• Was able to lead contracted and internal audits across global operations (including audit plans, CAPA management, audit checklists, audit reports and audit certificates).
• Collected and reviewed information relevant to the scope of the audit.
• Provided factual, clear, concise, and complete quality deliverable.
• Developed and oversaw and reviewed and approved CAPA resolutions for accuracy, completeness, and closure.
• Facilitated communications across the project teams and / or with the client regarding audit progress, where indicated and were assigned as the lead on a project.
• Frequently served as the lead auditor for contracted and internal audits.
• Determined, tracked and reviewed milestones, tasks, timelines and audit hours for all audits activities for assigned projects, ensuring adherence to budget and contact, when applicable.
• Worked with data management to obtain reports and listings of data.

• Responsible for the design and execution of the Quality Management system as defined by the FDA and external clients.
• Conducted internal audits of PPD processes and systems, in collaboration with the functional department tat defined the problems and problem solution strategies.
• Established quality and performance matrices and analyzed trends and presented results to peers and senior management.
• Served as the corporate subject matter-expert for all regulations.
• Developed and delivered training initiatives regarding quality management.
• Produced and maintained audit plans for allocated projects and identified audit candidates.
• Conducted GxP audits for clinical studies and internal processes.

• Directed all aspects of project management including planning, budgeting, staffing, scheduling, monitoring, and reporting.
• Formulated long-term objectives while managing day-to-day operations.
• Managed multiple projects simultaneously while staying within deadlines.
• Mentored and coached staff members, enabling them to reach their highest potentials.
• Provided leadership in times of crisis or change initiatives.
• Organized resources efficiently to maximize productivity and minimize costs.
• Created and managed budgets, ensuring financial targets were achieved.
• Monitored customer feedback regularly to improve customer experience.
• Cultivated relationships with key internal and external stakeholders.
• Established performance metrics to track progress and success of initiatives.
• Collaborated with stakeholders to identify areas for improvement and develop strategies for growth.
• Implemented effective policies and procedures that enabled the organization to meet compliance requirements.
• Spearheaded new business development initiatives that drove revenue growth.
• Reviewed reports prepared by subordinates for accuracy and completeness.
• Analyzed industry trends to inform decisions on product offerings or services.
• Communicated regularly with producers to update on status of production and potential issues.
• Negotiated with vendors to acquire appropriate equipment.
• Recruited top talent through targeted outreach efforts.
• Demonstrated and supported continuous improvement and growth mindset.
• Set and implemented strategic goals and initiatives to align company with mission, values, and vision.
• Facilitated open communication between departments to improve collaboration among teams.
• Spearheaded multiple projects from concept through completion while successfully managing budgets and timelines on each project.
• Established and monitored KPIs to optimize company performance.
• Utilized data analytics techniques to identify areas for improvement.
• Established and implemented departmental policies, goals, objectives and procedures in conjunction with board members, organization officials, and staff members.
• Conducted and management various GxP audits across the organization.

• Documented all audit findings and prepared detailed reports for management review.
• Maintained accurate records of audit work papers for future reference.
• Planned and performed GxP audits and reported findings.
• Worked with DM for data analysis and audits.
• Developed and administered training to Internal and external departments.
• Formulated and worked with internal teams to develop SOPs.
• A subject matter expert person of contact.

• Entered Clinical Data and conducted analysis of the data.
• Provided technical expertise in design, development and implementation of database solutions.
• Optimized existing databases for improved performance through indexing strategies and query optimization techniques.
• Worked in SQL and SAS during data management.
• Worked to validate Oracle Clinical in-house.
• Conducted GxP audits and reported audit findings.
• Formulated and maintained a CAPA database.
• Developed and maintained SOP for each department.