KEISHA N. TAYLOR
St Louis,MO
Summary
Driven Associate Director offering many years of progressive experience in industry. Versed in project management and quality systems implementation. Skilled in developing and implementing quality and compliance strategies to increase efficiency and performance. Passionate about driving business growth, mentorship and creating a positive and inclusive work environment. Adept at supporting and enhancing operations with a decisive leadership style and strategic approach to decision-making. Continuous working knowledge of 21CFR820, 21CFR210/211 , ISO 13485, ISO 9001, MDSAP, IVDR and additional applicable regulations.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Associate Director-Quality Systems
bioMérieux
St. Louis , MO
12.2017 - Current
- Manages quality personnel responsible for Document Control, Internal Auditing, Customer Complaints, and CAPA programs
- Serves as the site Internal Audit Program Manager and site Lead auditor
- Hosts, organizes, and prepares business responses from customer and regulatory audits (i.e., FDA, ISO, etc.)
- Responsible for maintaining and implementing the Quality System programs at the facility
- Develops and maintains the Quality Systems department budget
- Drafts and negotiates customer, distribution, and intercompany quality agreements
- Leads and facilitates initiatives to obtain and maintain ISO, IVDR, and MDSAP Certifications
- Develops, manages, and facilitates the site Quality System Management Review (QSMR)
- Serves as Quality Management Representative (QMR) backup to the Quality Site Sr
- Director
- Project lead for implementing highly visible quality projects and systems at affiliate sites
Manager-Quality Operations
Vericel Corporation (formerly Sanofi-Genzyme)
Cambridge , MA
09.2016 - 12.2017
- Managed quality personnel within the facility responsible for Document Control, Batch Release, Label Issuance, Customer Complaints, and CAPA & Deviation approval
- Represented QA during associated regulatory and internal audits
- Provided guidance on improving Quality processes, resolution of issues, and maintenance/improvement of the quality system and manufacturing processes
- Effectively led Deviation reduction team for the facility
- Served as QA Representative for site critical risk assessments and FMEAs
- Site QA Approver for document change controls, CAPA, Supplier Corrective Action Reports (SCAR), Laboratory Investigation Reports (LIRs), Customer Complaints, Validation and Deviations
- Managed QA activities associated with new product launches
- Performed investigations using Root Cause Analysis tools such as Five Whys, 5M+E, Is/Is Not, etc
- Determined training needs for the Quality Operations department
- Ensured that changes affecting multiple sites were evaluated and approved through the multi-site change control process
Manager-Quality Operations
bioMerieux
Durham , NC
02.2016 - 09.2016
- Managed quality personnel within the facility, including AQL Inspectors, Real-Time Review (Batch Release), Quality Floor Support technicians, and other quality roles, as applicable
- Represented QA and hosted associated regulatory audits (e.g
- FDA, ISO) and internal corporate audits as needed
- Reviewed and approved rework activities, document change controls, and site critical investigations requiring disposition
- Participated as a key member of the Management Staff in planning, reviewing, and impacting overall plant operations and decisions
- Managed and led continuous improvement programs within the Quality Assurance department
- Tracked, trended, and reported to senior executives all key quality indicators within the Quality Operations department
- Developed and implemented Quality and compliance training programs that provided necessary organizational knowledge to achieve company and regulatory objectives
Manager-Quality Engineering
bioMérieux
Durham , NC
09.2014 - 02.2016
- Managed and led a team of Quality Engineers responsible for authoring and approving site investigations
- Ensured that decisions were made based on sound Quality principles and regulatory guidelines
- Provided solutions and recommendations for roadblocks associated with difficult investigations
- Represented QA in all associated regulatory audits (e.g
- FDA, LRQA, ISO) and internal audits as needed
- Provided guidance to the Quality Floor Support team in relation to product containment and determination of non-conformances
- Provided guidance on improving quality processes, resolving issues, and maintaining/improving the quality system
- Authored and provided final QA approval of site critical investigations related to product disposition
- Provided routine analysis of performance indicators
- Presents this information to senior management and associated regulatory bodies
- Proposed Corrective and Preventive Actions (CAPA) to reduce deviation occurrences
Associate Staff Quality Engineer
bioMérieux
Durham , NC
04.2013 - 09.2014
- Coached and mentored investigators conducting in-depth investigations and provided guidance on how and when to use Root Cause Analysis Tools
- Evaluated newly initiated nonconformances to determine criticality and impact on the final product
- Served as a Subject Matter Expert for the TrackWise quality system
- Provided site-wide training for SAP and CAPA programs
- Quarantined and managed nonconforming material
- Supported containment activities involving product stop shipments and recalls
- Conducted and supported critical-level customer complaints and internal investigations to determine root causes using Root Cause Analysis Tools (e.g
- Five Whys, Fishbone, 5M+E)
- Reviewed and approved rework activities, document change controls, and Level 1 investigations for Manufacturing, Engineering, Quality Control, and Quality Assurance departments
Sr. Quality Engineer
Bausch & Lomb
Greenville , SC
04.2012 - 04.2013
- Independently led failure investigations for aseptic filling processes, gamma irradiation, packaging and compounding areas using root cause analysis tools, and proposing/implementing systemic corrective actions
- Guided engineering/manufacturing personnel in establishing appropriate qualification and validation criteria
- Reviewed and approved internal investigations, change controls and validation reports
- Used Sampling Principles & AQL to determine defect rates and created sampling instructions to identify defects
- Independently assessed product impact and recommended lot dispositions through Material Review Board (MRB) discussions
- Identified areas of systemic weakness, and led initiatives to implement corrective actions by using relevant statistical tools for leading problem solving activities
- Performed external audits related to plastic component vendors
- Participated and supported the quality department in regulatory audits and audit responses (e.g
- FDA and ISO audits)
Compliance Engineer
Covidien
Raleigh , NC
08.2011 - 04.2012
- Used root cause analysis tools (Kepner-Tregoe (KT) Analysis, Five Whys, Kaizen, Fishbone Diagrams, Cause & Effect, etc.) to determine root cause of internal investigations
- Assessed product impact and recommended lot dispositions based on regulatory standards and quality requirements
- Generated and executed CAPA items to reduce exceptions/deviations and improve quality
- Led and authored major investigations related to manufacturing, vendor issuance, temperature-sensitive goods, stability, and microbiology deviations
- Created and revised Standard Operating Procedures (SOPs) and other controlled documents to ensure compliance
Quality Engineer
Covidien
Maryland Heights , MO
09.2008 - 08.2011
- Evaluated product impact by utilizing and developing statistical tools such as SPC, FMEA DOE, OEE, Test Plans, etc
- Championed the implementation of Statistical Process Controls (SPC) in manufacturing areas and trained technicians on its use
- Returned profitable products back to market following recalls and DPO statuses as a member of the technical support team selected by Senior Leadership
- Developed and maintained metrics for incidents, deviations, batch record errors, and CAPA items
- Led and authored major investigations favorable to regulatory agencies resulting from product recalls and implemented mediations to prevent reoccurrence
- Aggressively used root cause analysis tools (Kepner-Tregoe (KT) Analysis, Five Whys, Kaizen, Fishbone Diagrams, etc.) to determine the root cause
- Worked with site leadership to support cost savings initiatives utilizing Lean and Six Sigma tools
- Recommended and implemented process improvements to maintain cGMP standards throughout the production areas
- Performed and reviewed internal and external audits to implement and improve best practices
Education
Doctorate of Management - Organizational Leadership
University of Phoenix St
true03-2025
Masters Business - Administration
University of Phoenix St
01.2010
B.S - Biological Sciences
Southern Illinois University
01.2005
Skills
- Decision-Making
- Strategic leadership
- Quality Systems Development
- Team Collaboration and Leadership
- Staff Development
- Critical Thinking
- Coaching and Mentoring
- Crisis Management
- Project Management
- Regulatory Compliance
- Contract Management
Certification
- ASQ-CQA
Affiliations
- Adjunct Professor-Lindenwood University Plaster College of Business (2022-Present)
Timeline
Associate Director-Quality Systems
bioMérieux
12.2017 - Current
Manager-Quality Operations
Vericel Corporation (formerly Sanofi-Genzyme)
09.2016 - 12.2017
Manager-Quality Operations
bioMerieux
02.2016 - 09.2016
Manager-Quality Engineering
bioMérieux
09.2014 - 02.2016
Associate Staff Quality Engineer
bioMérieux
04.2013 - 09.2014
Sr. Quality Engineer
Bausch & Lomb
04.2012 - 04.2013
Compliance Engineer
Covidien
08.2011 - 04.2012
Quality Engineer
Covidien
09.2008 - 08.2011
Doctorate of Management - Organizational Leadership
University of Phoenix St
Masters Business - Administration
University of Phoenix St
B.S - Biological Sciences
Southern Illinois University
- ASQ-CQA
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