QA Manager Resume Example

Highly sought leader, successfully exceeding deadlines, remediating GMP QMS, eQMS under challenging conditions; Consent Decree, Warning Letter, FDA Form 483, budget & personnel constraints, drug shortages, & ceased operations. Scope inclusive of small to large size organizations across, pharmaceutical, biologic, medical device, & compounding; organizations including, Baxter Healthcare Inc., AbViro LLC, Tanner Pharma Group Inc., Meridian Medical Technologies Inc., a Pfizer, Company, Kedrion Biopharma Inc.,Medicago Inc., Getinge Group Inc., PharMEDium LLC, IQVIA Inc., Zimmer Biomet Inc.

Provided strategic leadership & tactical & support for:

• NOTE: Served as interim QA Director at Kedrion; converted to full-time
• Authored product complaint investigations
• Authored, reviewed & approved non-conformance investigations
• Created, revised, delivered & evaluated training systems & material
• Managed & authored supplier quality agreements
• Developed global eQMS harmonized implementation strategy for Drug Supply Chain & Security Act (DSCSA); advised executive team; Collaborated with FDA DSCSA Center of Excellence (University of Tennessee, Plough Center)
• Approved GCP deviation investigations (phase III)
• Process mapped, designed blueprints & managed implementation of eQMS (TrackWise, Master Control) to support training, document control, laboratory (OOS) & manufacturing investigations
• Developed SOP template, authored, reviewed, & approved SOP, developed & implemented technical writing & human factors standards for controlled documents, including master batch records
• Managed quality focused continuous improvement projects sharing lessons learned with corporate & multiple facilities.
• Supported FDA inspection; on-call 24 hours/7 days support over approximately 2.5 months; drafted & advised regarding 483 FDA observation responses
• Fielded frequent & extensive FDA correspondences & lead meeting at CBER with 23 FDA Inspectors, managed 100+ consultants in supporting an in-depth & extensive site-wide FDA Form 483 remediation while ensuring new construction for API aseptic operations in support of drug shortage under significant challenges; budget & staff constraints, > 60% novice quality & compliance knowledge, skills & abilities (KSA), mold remediation & BPDR management
• Staffed & deployed QMS/eQMS remediation plans within 2 months; established position curriculum & incorporated training requirements into newly established position curriculum
• Led meeting with 23 FDA Inspectors at FDA (CBER); gained remediation strategy approval to resume limited aseptic API operations
• Provided quarterly FDA Form 483 status reports to FDA (CBER)

• Dedicated & trusted resource to senior leadership
• Self-driven, collaborative, strategic technical advisor to senior executive leadership; analyzed multiple product data sources for adverse trends to recommend a new risk-based product portfolio strategy & site metrics (KPI).
• Ensured effective CAPA closure, monitored & presented adverse trends to leadership.
• Coordinated remediation strategy between quality, operations, information technology (IT), training.
• Led eQMS implementation for deviation investigations, defined user requirements for process blueprint, developed procedures & corresponding training for newly designed eQMS.
• Developed new communication process of audit observations across OTC division & corporate.
• Advised, assisted QA Vice President (VP) & senior quality leadership in developing new site product portfolio to support reopening facility following successful 483 remediation.

• Supported implementation of eQMS for first $2 billion profit vaccine under Consent Decree remediation. Produced cost savings of $150K by preventing further product loss.
• Achieved 3 promotions in 8 years; QA Associate I, QA Sr. Specialist II, QA Associate Director.
• Supported process improvements to transition from paper-based QMS to eQMS.
• Honored to be requested to provide error reduction presentation to QA President and all QA Vice Presidents (VP) regarding Human Performance Model (HPM from N. America Commercial Nuclear). Upon completion of scheduled 20 minute presentation, all declined their time at meeting granting 2 additional hours of presentation time. Immediately following meeting, asked to implement HPM globally!
• Received formal global recognition for overall deviation rate & human error rate reduction, investigation system process improvements (globally) & Human Performance Model implementation.
• Standardized investigation process in SAP across Wyeth globally, implemented use of standard causal codes across sites globally (40+ sites), improved causal analysis, data collection, data analysis, & CAPA effectiveness; Wyeth Best Practice Award for >$150K+ savings.
• Managed (dotted line) eQMS process improvement project teams across NC, NY, Puerto Rico, & Ireland; collaboration with corporate QA.
• Created How to Measure CAPA Effectiveness process for company. Upon successful implementation and management for 1 year in NC, process was rolled out globally.
• Trusted resource to leadership. Accompanied QA Director as primary contact for deviation investigations during FDA inspection. I was asked to advise on select deviation investigations across multiple sites and to review certain deviation investigations prior to audits.
• Managed product recall resolution for different site in different division achieving FDA acceptance for CAPA protocols following 3 previously failed attempts. Participation with this recall was requested by corporate quality leadership.
• Collaborated with corporate & multiple facilities upon request by senior quality leadership to provide auditing, deviation investigation & human error reduction (HPM techniques from commercial nuclear) training.
• Managed, monitored & presented OOS & deviation investigation data to site Quality Council. Modified data analysis to be rate based and include graphical presentation; adopted by all departments.
• Project co-lead for creating Wyeth's Writing Standards for Controlled Documents that included technical writing and human factoring standards; successfully implemented at site and adopted globally.
• Led batch record error reduction initiative; human factored master batch record (MBR).