TaShemma Jackson

Transformational Quality Management professional with 20+ years of experience leading quality systems, compliance initiatives, operational process improvements, and cross-functional quality programs within highly regulated manufacturing environments. Proven expertise designing, modernizing, and sustaining Quality Management Systems (QMS) that improve operational efficiency, strengthen compliance, reduce quality risks, and support scalable manufacturing operations. Experienced bridging quality requirements with practical operational execution by partnering closely with manufacturing, engineering, operations, and quality teams to drive accountability, process consistency, and continuous improvement.

Strong background in ISO 9001/ISO 13485 environments, audit readiness, CAPA systems, risk mitigation, root cause analysis, and data-driven quality decision-making. Recognized for building collaborative quality cultures focused on prevention, operational excellence, and sustainable compliance.

QUALITY ASSURANCE SPECIALIST - Celden Consulting

(2025-01)

• Lead quality investigations, compliance assessments, and process improvement initiatives within regulated manufacturing environments.
• Analyze quality trends and operational risks to support continuous improvement and defect prevention initiatives.
• Perform root cause analysis and support implementation of corrective and preventive actions designed to improve operational effectiveness and reduce recurrence.
• Collaborate cross-functionally with operational teams to strengthen quality processes and improve compliance performance.
• Review and revise SOPs and quality documentation to support standardized and scalable operational processes.

SR. MANAGER, QA BATCH RELEASE - Emergent BioSolutions / Bora Pharmaceuticals - Baltimore, MD

(2022-10 - 2025-01)

• Led quality oversight activities supporting pharmaceutical manufacturing operations and batch disposition processes.
• Managed a team of 12 supporting batch documentation review, operational quality oversight, and regulatory compliance activities.
• Built strong partnerships with production, regulatory affairs, engineers, and Quality teams to improve process efficiency, quality consistency, and operational execution.
• Directed investigations, CAPA implementation, and root cause analysis activities to reduce quality risks and improve manufacturing performance.
• Presented quality metrics and operational performance trends during Quality Management Review meetings to support data-driven decision-making.
• Across the various manufacturing departments, I established a culture where quality was a shared responsibility with department managers and production operators demonstrating ownership and accountability.
• Responsible for implementing data driven decision-making within QMS while using trends to prioritize improvements and optional strategy.

MANAGER, DOCUMENT CONTROL & TRAINING - Emergent BioSolutions - Baltimore, MD

(2021-09 - 2022-10)

• Led Document Control and Training teams supporting enterprise quality systems and manufacturing compliance activities.
• Oversaw document lifecycle management, training compliance, and operational quality processes to maintain inspection readiness and standardized execution.
• Improved quality system processes through workflow optimization, compliance monitoring, and process standardization initiatives.
• Partnered with operational and quality stakeholders to strengthen quality culture, improve accountability, and enhance training effectiveness.
• Supported implementation of scalable quality systems supporting organizational growth and operational efficiency.

DOCUMENT CONTROL SUPERVISOR - Emergent BioSolutions - Baltimore, MD

(2019-06 - 2021-09)

• Supervised document control operations supporting manufacturing quality systems and compliance requirements.
• Managed controlled documentation processes, batch record oversight, and operational quality workflows.
• Supported continuous improvement initiatives focused on improving process efficiency, documentation accuracy, and audit readiness.
• Collaborated cross-functionally to identify process gaps and implement operational quality improvements.
• Assisted with quality metrics tracking and reporting activities to support operational decision-making.

QUALITY ASSURANCE COMPLIANCE MANAGER - Advance BioScience Laboratories - Rockville, MD

(2018-01 - 2019-06)

• Managed core Quality Managing Systems including CAPA, deviations, change control, audits, and training compliance programs.
• Conducted internal audits and compliance assessments to evaluate quality system effectiveness and operational adherence.
• Identified quality risks and implemented corrective actions to improve compliance performance and operational consistency.
• Implemented data driven decision-making within QMS while using trends to prioritize improvements and optional strategy.
• Supported continuous improvement initiatives and quality process enhancements across manufacturing and operational areas.
• Collaborated with cross-functional teams to strengthen quality culture and support sustainable compliance practices.

QUALITY ASSURANCE LEAD I - Sanofi Pasteur / Emergent (Contract, Maxis IT) - Rockville, MD

(2017-06 - 2018-01)

• Reviewed manufacturing documentation and batch records to ensure compliance with quality standards and operational procedures.
• Supported deviation investigations, CAPA implementation, and manufacturing quality oversight activities.
• Assisted with process improvements and inspection readiness initiatives.

SENIOR QUALITY ASSURANCE AUDITOR I - Ricerca Biosciences, LLC - Concord, OH

(2016-01 - 2017-06)

• Conducted internal audits and compliance assessments to evaluate quality system effectiveness and operational compliance.
• Identified process gaps, operational risks, and improvement opportunities supporting sustainable compliance initiatives.
• Delivered GMP/GDP training and compliance guidance to operational teams.
• Supported process improvement initiatives and audit remediation activities.

CHANGE CONTROL / DOCUMENT CONTROL SPECIALIST, QA - Philips Healthcare - Highland Heights, OH

(2015-01 - 2016-01)

• Supported quality systems management activities including change control, documentation oversight, and compliance reporting.
• Monitored operational quality processes and training compliance activities.
• Assisted with quality metrics reporting and continuous improvement initiatives.

Multiple Roles - Boehringer Ingelheim (BVL)

(2001-01 - 2014-12)

Supported manufacturing quality systems, operational process control, compliance oversight, training activities, and continuous improvement initiatives within FDA-regulated manufacturing environments.

• Change Control Specialist
• Batch Release Coordinator
• Batch Record Reviewer
• Document Control Specialist
• Manufacturing Specialist

Master of Business Administration - MBA - Fitchburg State University

Bachelor of Science - Business Management - University of Phoenix