Open To Work
Darlene J Pierson
Winston Salem
Work Preference
Job Search Status
Open to workDesired start date: Immediately
Desired Job Title
Senior Quality ManagerSenior Manager Global Quality and ComplianceSenior Quality EngineerManager Validation & MetrologySr. Validation EngineerWork Type
Full TimeContract WorkConsultingLocation Preference
RemoteOn-SiteHybridLocation: Winston Salem, US
Open to relocation: Yes
Salary Range
$150000/yr - $200000/yrSummary
Knowledgeable Sr. Manager, Quality and Compliance with proven record in overseeing quality assurance processes and driving continuous improvement initiatives. Led successful projects that enhanced operational efficiency and product reliability. Demonstrated expertise in regulatory compliance and quality auditing to ensure adherence to industry standards.
Overview
29
29
years of professional experience
Work History
Senior Quality Manager
ZigZagQA Inc.
09.2024 - 02.2026
- Conducted client audits (CSV, GxP and EU) remotely and onsite following each client’s guidelines and requirements.
- Consulted with auditee to identify remediation actions.
- Presented audit findings to client and authored final audit report.
- Authored SOPs training programs and policies for quality, CSV and eSig
- Remote
Senior Manager Global Quality and Compliance
Marken
Durham, NC
03.2019 - 12.2023
- Successful Sr. Manager of Global Validation Department overseeing thirty-three depots (GMP), twenty-three branches (GDP) and third-party depots along with global CSV.
- Development of System Use and Administrative SOPs, reviewed and approved the SOPs, disaster recovery plans, and business continuity plans.
Senior Quality Engineer
Haemonetics
Union, SC
05.2018 - 03.2019
- Direct Quality Inspectors to sample and inspect raw materials, in-process materials, labels and finished product effectively and efficiently.
- Lead CSV team to validation and release of new custom manufacturing system which includes raw materials specifications and tracking, production requirements, batch record release, inventory, and shipping.
- Reviewed and approved CSV lifecycle documentation including risk assessments, testing scripts, final reports, and trace matrices. Addressed deviations encountered during testing and resolved to ensure compliance.
- Performed Risk Assessments to identify gaps, address deviations and developed statistically relevant sampling plans and QC testing specifications for chemistry, microbiology, and physical testing.
- Audit and assess supplier capabilities to support product and business requirements including QC testing labs, consultant, calibration & validation services.
- Track external suppliers KPIs to evaluate and help create, maintain quality level requirements. Determine retention supplier retention status.
- Reorganized Documentation system and workflow to establish structured and effective workflow.
- Investigate non-conformances (OOS & OOT) utilizing SCAR, CAPA and risk assessment techniques.
- Initiate continuous improvement projects regarding ISO 7, and ISO 8, and ISO 5 cleanroom cleaning processes.
- Conducted internal and remediated external audits issues through closure.
- Mentored junior quality staff by leading training for QA / QC / validation including training for random sampling, Microsoft Word, Excel, COA reading, SharePoint, GMPs, ISO13485, GAMP 5 and revised SOPs.
- Developed FMEA to capture correct product manufacture, risk range, process development to aid in determining risk acceptance and risk mediation.
- Safety committee member
Manager Validation & Metrology
Herbalife
Winston Salem, NC
10.2013 - 12.2018
- Led developed and managed Validation Program for facility build and manufacturing startup (QC, QA MFG, CSV, cleaning, and facility).
- Develop Validation Master Plan (VMP) for facility and then standardize VMP and to Global facilities.
- Develop and institute validation policies for manufacturing equipment, packaging lines, CVS, and cleaning processes (CIP, COP, and manual cleaning).
- Authored or review and approve validation documentation including SOPs, IQ, OQ PQ and summary reports for, QC testing instruments, QA testing instruments, manufacturing equipment, packaging lines, and cleaning.
- Develop or review and approve CSV lifecycle documentation including SOPs, FS, DS, IQ, OQ, PQ, TM, and summary reports. Addressed deviations during testing by providing technical support and reviewing / approving risk assessments.
- Worked with IT on Change Controls, CAPAs, disaster recovery plans and business continuity plans, provided QA review and approval.
- Participant on FMEA team to map process, identify risk, propose risk reduction, identify risk acceptance, and propose / participate in continuous improvement projects.
- Ensured all Validation & Metrology activities are compliant to state and federal regulatory bodies, and cGMP, ISO17025, ISO9001, GAMP 5, Halal and FSMA requirements.
- Design a Metrology Laboratory, then developed and established an ISO17025 certified Metrology Department
- Manage and track Validation and Metrology departmental metrics prepare reports and present departmental and project status to senior management.
- Conducted internal audits and external supplier audits, delivered remediation plans and final reports.
- Established and maintained schedule of supplier annual audits and made decisions regarding supplier retention based on KPI tracking, supplier quality, and audit findings.
- Validated QMS system includes modules regarding CAPAs, document control, internal / external audits, and risk assessments.
Sr. Validation Engineer
Dendreon
Morris Plains, NJ
09.2009 - 09.2013
- Track validation departmental metrics to develop validation strategies and report departmental status to senior management.
- Lead and coordinate re-qualification program to ensure compliance.
- Executed risk assessments for CAPA responses, internal / external audit responses, and continuous improvement projects to identify risk acceptance.
- Delivered a training program, then mentored and trained new team members and equipment owners on equipment and computer systems.
- Designated as FDA escort and validation subject matter expert during regulatory inspections and audits.
- Perform supplier audits for raw materials, QC testing labs (cGCP and cGLP), equipment, and software, prepare audit report, and determine supplier status.
- Validation department lead in cross-functional teams for change controls and cGxP related problem resolution.
- Develop, author, review and approve validation and CSV documents (SDLC) including project plans, URS, protocols, SOPs, and final reports (IQ, OQ and PQ).
- Develop and execute qualification protocols for cGxP equipment, cleanrooms, warehouses, product shipping conditions, cleaning and CSV systems, compiles data and authors final reports (IQ, OQ, and PQ).
Validation Specialist II
Tandem Labs
West Trenton, NJ
02.2007 - 07.2009
- Developed and validated a tracking system of calibration, qualification and validation of laboratory equipment and systems.
- Authored Validation Master Plan and validation documentation: Responsibility Matrix, Design Configuration, User Requirement Specifications, Traceability Matrix, IQ, OQ, PQ, and Summary Report.
- Conducted internal audits for adherence to cGLP and cGCP regulations.
- Executed qualification protocols for cGLP equipment and systems, compiled the data and authored final reports (IQ, OQ, and PQ).
- Developed and implemented new instrument/software SOPs. Review and revise existing SOPs.
- Collaborated with clients to determine required quality test methods, wrote resulting work instructions.
- Participated as validation SME in client, FDA, and CLIA audits.
Associate Research and Development Scientist
Collagen Matrix Inc.
Oakland, NJ
08.1997 - 12.2006
- Team Leader coordinating product design and development (510K medical devices).
- Developed new products by preparation of experimental protocols, fabrication and evaluations of prototypes, data analysis, and summary report generation.
- Managed R&D laboratory including equipment validation, calibration, and preventative maintenance.
- Developed manufacturing processes at the pilot level.
- Collaborated with other departments and vendors to determine equipment selection and packaging requirements.
- Developed and executed packaging testing protocols such as tensile strength, burst, and shelf life.
- Authored User Requirement Specifications and validation protocols for manufacturing equipment (IQ, OQ, PQ).
- Executed qualification protocols for GLP equipment and systems, and author final reports (IQ, OQ, and PQ).
- Developed and implemented new instrument SOPs. Reviewed and revised existing SOPs.
- Functioned as Project Manager during facility expansion, overseeing consultants and contractors to ensure adherence to timelines.
- Participated as validation representative in FDA and ISO audits.
- Conducted internal audits using ISO, cGLP and cGMP guidelines, prepared audit reports and provided recommendations for findings.
Education
Associate of Science - Biology
Associate of Science - Medical Laboratory Technology
Biotechnology
GPA: 35 Credits
Skills
- Quality Assurance, Internal Audits, Regulatory Compliance, Corrective and Preventive Actions (CAPA), GxP, Root Cause Analysis, Quality Management System Qualification and Management, Quality Documentation Requirements, Process Improvement, Risk Management, Supplier Audits, Training and Mentorship, ISO, 13285, ISO9001, ISO27001, FDA Regulations, Validation, Computer Service Validation
- Corrective and preventive actions
- CAPA investigations
- Documentation control
- Quality management systems
- Quality assurance techniques
Areas of Expertise
- Comprehensive regulation and guidance knowledge: cGxPs, ISO17025, ISO9001, ISO13485, FDA regulations 21CFR Title 21 regarding medical devices and drugs. ICH/135/1995, EU Annex 13, EU Annex 11, GAMP 5, EU 2017/556, ICH Q9.
- Excellent Internal & External auditing skills.
- Experience collaborating with outside suppliers (components, chemicals, software, and equipment) including audit, capability assessment, and quality alignment.
- Validation SME including VMP, Risk Assessments, User Requirements, Design Specification, Test Plans, FAT/SAT/Commissioning, DQ, IQ, OQ, PQ, QC Testing Equipment, Cleanroom Qualification, Environmental Control, Cleaning, Process, and Facilities.
- Computer System Validation (CSV) proficiency for legacy systems and new systems including lifecycle plans, validation plans, data migration, disaster recovery and summary reports according to FDA 21 CFR Part 11, 211, 820; EudraLex Annex 11, and guidance (e.g., FDA, GPSV, ICH, PIC/S), and industry best practices (e.g., ISPE, GAMP 5)
- Strong Technical Writing skills, authoring of SOPs, policies, justifications, summary reports, risk assessments, quality plans, quality manual, validation documentation, specifications, and methods.
- Comprehensive Quality Management System understanding of CAPAs, Non-Conformances, Audit Responses, investigations, change controls and SCARS using risk-based processes.
- Experienced in pilot plant through scale-up to a GxP manufacturing and distribution facilities, and expansion of existing GxP sites, including the installation and ISO17025 certification of a Metrology Lab.
- Managed teams where personnel were valued, trained, and mentored while tracking KPIs, maintaining budgets, performing strategic, and developing process improvement projects.
- Safety Committee member and safety advocate.
- Extremely successful working directly with clients regarding conducting audits, QTA development, CSV topics, validation (CSV, facility and equipment) and issue remediation.
Timeline
Senior Quality Manager - ZigZagQA Inc.
09.2024 - 02.2026
Senior Manager Global Quality and Compliance - Marken
03.2019 - 12.2023
Senior Quality Engineer - Haemonetics
05.2018 - 03.2019
Manager Validation & Metrology - Herbalife
10.2013 - 12.2018
Sr. Validation Engineer - Dendreon
09.2009 - 09.2013
Validation Specialist II - Tandem Labs
02.2007 - 07.2009
Associate Research and Development Scientist - Collagen Matrix Inc.
08.1997 - 12.2006
County College of Morris - Associate of Science, Medical Laboratory Technology
William Paterson - , Biotechnology
County College of Morris - Associate of Science, Biology