Misty Armstrong
Simi Valley,CA
Summary
Dedicated professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. A strong project leader and quality professional with strong analytical and problem-solving skills. Proven ability to lead and influence a cross-functional team as well as global site and functional area employees to a successful project outcome.
Expertise in commercial and clinical quality assurance, operations, quality control, oral solid dose and parenteral aseptic manufacturing, drug and device complaint management, critical issue management, regulatory notifications, recalls, and audits.
Have a successful track record of leading complex business critical projects that involved international projects partnering with external quality, regulatory affairs, quality control laboratories, facility quality assurance, process development, & contract manufacturing organizations to achieve success for the company.
Overview
24
24
years of professional experience
Work History
Director, External Quality Operations (EQO)
Gilead Sciences
12.2023 - Current
- Functional leader responsible for Quality Product Team Leads (QPTLs), Quality Functional Site Leads (QFSLs), API (Active Pharmaceutical Ingredient) Leads, and related Operational Leads (OLs)
- Provides Quality Oversight of commercial and developmental products at CMOs for: API, oral solid dose, biologic, and aseptic (i.e., parenteral), and manufacturing
- QPTL who supports other QPTLs, API Leads, OLs, AQA (Analytical Quality Assurance) OLs, and specialists and provides guidance, resources as needed for issues/trainings/communication/collaboration/continued development
- Manage over 20 Quality Assurance (QA) personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews, and guiding personnel in longer-term development.
- Acts as escalation contact for complex and high impact quality issues, concerns, and decisions.
- Performs work that consistently requires independent and/or strategic decision making and exercise of risk-based decisions.
- Responsible and accountable for reviewing and approving: Contract Manufacturing Organizations (CMOs) product-impacting critical investigations, supply chain tables, bulk hold time studies/protocols/reports, ADME (absorption, distribution, metabolism, and excretion) studies, batch records/protocols/reports, process validation sampling plans, product-impacting Gilead change controls, API and DP specifications, and part numbers.
- Reviews & approves regulatory filings, supports technology transfers, and participates in program/project reviews.
- Partners with Development, Manufacturing, Supply Chain, Outsourcing, and Drug Substance to deliver on development programs.
- Accountable for supporting new product launches, health authority requests, product complaints, label review and approval, drug product (DP) and API process validation.
- Supports Gilead PAI inspection preparation efforts and post-PAI follow up with CMO and good clinical practice (GCP) audits/inspections at clinic sites.
- Supports good manufacturing practice (GMP) inspections and audits from both regulatory authorities and collaborators.
- Partners with CMOs to ensure compliant manufacturing of products required for clinical supply, process validation and commercial supply.
- Assure CMOs meet Gilead’s quality, regulatory, and compliance standards, to ensure sustainable delivery of quality product to patients and maintain good working relationship.
- Identifies and drives quality system process optimization initiatives and addresses opportunities for efficiency and capacity improvements.
- Collaborates with manufacturing, supply chain, and other functions to support day to day GMP operations at site as well as advise on problem solving and investigations at manufacturing sites.
- Collaboratively led a pilot team which led to successful implementation of cross-functional product/program-based structure within quality.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
- Trained and guided team members to maintain high productivity and performance metrics.
Associate Director, External Quality Operations (EQO)
Gilead Sciences
10.2022 - 12.2023
Senior Manager, Developmental & Commercial Quality Systems and Operations
Gilead Sciences
01.2018 - 01.2021
- Managed global clinical and commercial complaint management process
- Worked extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
- Interfaced with Gilead sites and contract manufacturers to address and resolve more complex product/process performance issues
- Managed QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews, and guiding personnel in longer-term development
- Provided leadership and direction in quality systems and continuous improvement initiatives for commercial drug product and serves as a quality expert in GMP standards, policies, guidelines, and procedures
- Management of the critical quality issue process & act as an escalation point for non-routine issues/decisions
- Managed regulatory notifications to agencies, including field alerts and drug notifications.
- Interface with regulatory agencies as required.
- Lead the execution of mock recalls and product actions in the marketplace, including agency status reporting.
- Directed development of strategic programs/initiatives, determined metrics for program success, and evaluates performance against metrics
- Collaboratively Developed, implemented, and maintained systems, programs, and processes to ensure compliance with Current GMPs and Good Laboratory Practices (GLPs), along with compliance of protocols, and safety regulations.
Manager, Developmental & Commercial Quality Systems and Operations
Gilead Sciences
01.2017 - 01.2018
- Managed global clinical and commercial complaint management process
- Worked extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
- Interfaced with Gilead sites and contract manufacturers to address and resolve more complex product/process performance issues
- Managed QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews, and guiding personnel in longer-term development
- Provided leadership and direction in quality systems and continuous improvement initiatives for commercial drug product and serves as a quality expert in GMP standards, policies, guidelines, and procedures
- Management of the critical quality issue process & act as an escalation point for non-routine issues/decisions
- Managed regulatory notifications to agencies, including field alerts and drug notifications
- Interface with regulatory agencies as required
- Lead the execution of mock recalls and product actions in the marketplace, including agency status reporting
- Directed the development of strategic programs/initiatives, determined metrics for program success, and evaluates performance against metrics
- Collaboratively Developed, implemented, and maintained systems, programs, and processes to ensure compliance with Current GMPs and Good Laboratory Practices (GLPs), along with compliance of protocols, and safety regulations.
Quality Assurance Specialist
Kite Pharma
01.2016 - 01.2017
- Responsible for the preparation, review, and approval for lot disposition which included facilitating quality assurance related production and production related activities
- Reviewed and approved Manufacturing and Validation documents for Regulatory and Kite Compliance
- Gathered and managed metric information for use in continuous improvement of areas of responsibility
- Recommended and implemented changes to company procedures, work instructions, and policies in response to changes in regulations or standards.
Senior Quality Product Owner, Quality for Innovations
Shire (Formerly Baxalta/Baxter)
01.2015 - 01.2016
- Responsible for the following deliverables: product specifications, stability studies, maintenance and creation of the design history file, quality target product profile, and risk management documents
- Represented the quality function at project core teams of complex, business-critical, and inter-continental product development projects, and was accountable for the timely coordination and execution on quality owned project milestones and tasks
- Interacted with external quality, regulatory affairs, quality control laboratories, facility QA, process development, contract laboratories and authorities
- Participated in the preparation of Chemistry, Manufacturing & Controls (CMC) submission chapters, reviewed reports, participation in change control and deviation system, and other quality systems.
Project Lead, QA III
Shire (Formerly Baxalta/Baxter)
01.2014 - 01.2015
Senior Global Product Surveillance, QA
Shire (Formerly Baxalta/Baxter)
01.2009 - 01.2014
- Responsible subject matter expert for the complaint process (adverse events and product complaints) within global product surveillance
- Provided complaint or system training for outside groups (i.e., customer service, medical information)
- Monitored metrics for critical procedural requirements
- Assisted in writing, revising, and reviewing standard operating procedures (SOPs) associated with the Global Product Surveillance (GPS) process
- Directly involved in leading multiple process/product improvement projects which included Kaizens, corrective action preventative action (CAPAs), validations, development of new methodologies, and data generation
- Supported the marketing team to improve training across the field for use and preparation of a products.
Quality Associate II
Shire (Formerly Baxalta/Baxter)
01.2008 - 01.2009
Quality Associate I
Kelly Scientific, Baxter Biosciences
01.2008 - 01.2008
- Responsible for conducting investigations into exception reports, adverse events, media-fill failures, and other occurrences that resulted from a deviation to GMP procedures
- Supported the facility in GMP activities for the pharma-bulk manufacturing department
- Assured compliance with GMP, GDP, GLP, and company procedures
- Participated in the development, revision, and implementation of new standard operating procedures within the quality department
- Additionally, reviewed, and approved documentation for accuracy and compliance to procedures
- Supported process with timely closure of observations, corrective actions, exception reports, and audit commitments.
Nurse Technician
St. Francis Heart Hospital
01.2007 - 01.2008
- Responsible for providing basic patient care or treatments, such as phlebotomy, taking temperatures or blood pressures, dressing wounds, treating bedsores, giving enemas or douches, rubbing with alcohol
- Additionally, responsible for observing patients, charting (i.e., measured and record patients' vital signs, such as height, weight, temperature, blood pressure, pulse, and respiration) and reporting changes in patients' conditions, such as adverse reactions to medication or treatment, and taking any necessary action
- Cardiopulmonary resuscitation (CPR) & Basic Life Support (BLS) Certified
- Prepared patients for examinations, tests, or treatments and explained procedures.
Senior Research Associate, Protein Formulation, Pharmaceutics
Amgen
01.2004 - 01.2007
- Responsible for conducting analysis using the following instrumentation: Agilent High Performance Liquid Chromatography (HPLC)- Capillary Electrophoresis (CE), Size Exclusion Chromatography (SEC), Reverse Phase (RP-HPLC), Denatured Size Exclusion Chromatography (dSEC), Bioveris Instrument (9G8A Binding Assay), UV-Spectroscopy, Viscosity Testing, Particle Count Testing, and Centrifuge use
- Planned, conducted, analyzed/interpreted data, recorded experiments, contributed to technical reports, and presented data to the pharmaceutics department
- Contributed to the set-up, and design of narrow potential of hydrogen (pH) and buffer screen studies for monoclonal antibodies as well as dialyzed and formulated them for stability studies
- Prepared technical reports to support raw data for final formulation and pre-clinical stability studies
- Developed procedures for the 9G8A binding assay development, as well as implemented SOPs
- Trained employees and interns on the use of analytical instrumentation
- Contributed to research projects, and presented results at group meetings, as well as presented scientific posters at off-site meetings and seminars
- Developed Size Exclusion Chromatography (SEC) methods for monoclonal antibodies and IgG1 proteins.
Research Associate
Kelly Scientific, Amgen
01.2002 - 01.2002
- Responsible for trouble-shooting various instruments and completing analysis of protein stability samples using HPLC (CEX, SEC, RP-HPLC), Mass Spectrometry, and gel analysis.
Independent Study
Biology Department, CLU
01.2000 - 01.2002
- Responsible for performing independent research projects that involved the sequencing of cloned thermoplasma acidophilus DNA
- Completed the primer walking assay for areas of interest on the thermoplasma to determine the genome of thermoplasma acidophilum
- Conducted testing on the purification of an unknown virus.
Education
Master’s in Business (M.B.A.) - Management and Organizational Behavior
California Lutheran University
Thousand Oaks, CA2010
Bachelor of Science (B.S.) - Biological Science
California Lutheran University
Thousand Oaks, CA2002
Skills
- Project Management; Project Coordination
- Team Management; Organizational Development; Strategies and goals
- Operations Management; Issues Resolution; Strategic Planning
- Program Management; Strategic Planning; Creativity and Innovation
- Verbal and written communication
- MS Office; Sharepoint; Visio; Oracle EBS; SAP; Windows; Outlook; MAC; Word; Excel; PowerPoint; Trackwise; Agile; Veeva; LIMS
Professional Expertise
- Yellow Belt/Lean Practice
- GMP/ISO/CFR/ICH
- Manage Study Timelines
- Critical Issue Management
- Project Management Methodology
- Regulatory Notifications
- Kaizen Lead/CAPA Project Leader
- Product Actions/Recalls
- Project Lead
- Root Cause Analysis
Timeline
Director, External Quality Operations (EQO)
Gilead Sciences
12.2023 - Current
Associate Director, External Quality Operations (EQO)
Gilead Sciences
10.2022 - 12.2023
Senior Manager, Developmental & Commercial Quality Systems and Operations
Gilead Sciences
01.2018 - 01.2021
Manager, Developmental & Commercial Quality Systems and Operations
Gilead Sciences
01.2017 - 01.2018
Quality Assurance Specialist
Kite Pharma
01.2016 - 01.2017
Senior Quality Product Owner, Quality for Innovations
Shire (Formerly Baxalta/Baxter)
01.2015 - 01.2016
Project Lead, QA III
Shire (Formerly Baxalta/Baxter)
01.2014 - 01.2015
Senior Global Product Surveillance, QA
Shire (Formerly Baxalta/Baxter)
01.2009 - 01.2014
Quality Associate II
Shire (Formerly Baxalta/Baxter)
01.2008 - 01.2009
Quality Associate I
Kelly Scientific, Baxter Biosciences
01.2008 - 01.2008
Nurse Technician
St. Francis Heart Hospital
01.2007 - 01.2008
Senior Research Associate, Protein Formulation, Pharmaceutics
Amgen
01.2004 - 01.2007
Research Associate
Kelly Scientific, Amgen
01.2002 - 01.2002
Independent Study
Biology Department, CLU
01.2000 - 01.2002
Master’s in Business (M.B.A.) - Management and Organizational Behavior
California Lutheran University
Bachelor of Science (B.S.) - Biological Science
California Lutheran University