Teresa Huddleston - Senior Consultant, Quality Assurance & Regulatory

Teresa has more than 15 years of quality assurance, regulatory, manufacturing and clinical operations experience in the medical device and pharmaceutical industry. During several years as a Quality Assurance and Drug Supply Specialist with Houston-based Encysive Pharmaceuticals, she worked closely with clinical operations and contract manufacturers to provide investigational supplies and services for worldwide clinical studies.

Teresa's experience in regulatory affairs with Guidant also gives her an in depth understanding of the challenges medical device manufacturers face in maintaining compliance with US and international regulations, and dealing with Notified Bodies and regulatory agencies worldwide. She applies this knowledge for the benefit of Emergo clients as she works with them to implement Quality Management Systems, perform audits and provide consultative advice on compliance issues.

EXPERIENCE:

Quality Assurance and Drug Supply Specialist, Clinical Development, Encysive Pharmaceuticals (2003-2007)

• Participated in GCP/GMP internal and external audits.
• Evaluated and corrected audit findings to ensure completion of corrective actions.
• Served as Quality Assurance representative on cross-functional global project teams.
• Performed final release for investigational and marketed products.
• Tracked and trended planned and unplanned deviations, out-of-specification results, failure investigations, complaints, and corrective actions.
• Reviewed and approved clinical protocols, validation reports, and other quality documents.
• Wrote new and revised Quality Assurance and Clinical Development procedures.
• Created and revised multi-lingual product labels.
• Investigated and resolved product complaints.
• Developed Product Specifications and Test Summary Forms required for clinical product releases.
• Performed file audits on Clinical Development documentation.
• Performed vendor audits for clinical services, supplies and packaging.
• Revised and approved primary and secondary packaging Job Summaries.
• Provided materials management and logistics support for worldwide drug supply.
• Continuously monitored patient enrollment projections and developed plan for global drug supply.
• Primary interface for global Interactive Voice Response System and User Requirements.

Senior Regulatory Compliance Auditor and QA Supervisor, Guidant Corporation (2001-2003)

• Audited areas of the Guidant quality system such as clinical, R&D and manufacturing.
• Created audit checklists based on applicable regulations and pertinent Guidant quality system/procedural requirements.
• Developed audit plans and schedule and reviewed budgetary impact.
• Served as escort for inspectors and assessors from regulatory agencies and notified bodies.
• Audited and qualified potential vendors/suppliers.
• Served as quality system resource to business units.
• Supervised first and second shift quality assurance personnel.
• Performed internal GLP/GMP audits.
• Interfaced with manufacturing management to identify quality system issues, and approve corrective action plans.
• Responsible for all quality assurance functions, including product releases, material disposition and corrective action activities.
• Responsible for quality control functions, including calibration, raw material releases and in-process testing.
• Developed direct reports by identifying and conducting appropriate training.
• Developed work schedules by assessing priorities, workload and available resources.
• Provided support for Document Control, including releasing documents in Documentum.

Biology Instructor, Collin County Community College(2000-2001)

• Planned and delivered lectures to students enrolled in Biology I & II level courses.
• Set up laboratory experiments associated with Biology I & II level course.

Sr. Clinical Project Coordinator, Pharmaceutical Operations, Allergan, Inc. (1993-1998)

• Coordinated activities in preparation of investigational supplies for GLP and GMP studies.
• Developed and maintained lab tracking tools for analytical and microbiological testing.
• Developed Supply Agreements with contract suppliers and Clinical Investigators.

Manufacturing Supervisor, Dilatation, Guidant Corporation (1992-1993)

• Delegated responsibilities among 32 Production Assemblers involved in building RX perfusion catheters used during angioplasty.
• Responsibilities included GMP and safety compliance, process improvements, personnel relations and training/development.

AREAS OF EXPERTISE:

Devices:

• Angioplasty catheters
  

QA/RA:

• ISO 13485:2003
• FDA Quality System Regulation (21 CFR Part 820)
• FDA Good Laboratory Practices (GLP)
  
• CAPA
• Auditing

CERTIFICATIONS:

• ASQ Certified Quality Auditor (CQA)
  
• ASQ Certified Quality Manager (CQM)
  

EDUCATION:

• Bachelor of Science in Biology - Winston-Salem State University

• Masters of Science in Biology- North Carolina Agricultural and Technical State University

HOME BASE:

• Texas, USA