Sheila Wade
Dr. Reddy's Laboratories
Mount Laurel,NJ
1
Certification
25
years of professional experience
Quality assurance and risk management professional specializing in product complaint activities within GMP environments. Proven track record of coordinating investigations, training internal teams, and maintaining over 95% investigation closure rates to ensure compliance with regulatory standards.
Work History
Manager/Lead Associate Product Complaints
2 Years 6 Months- Reviewed investigations from internal and external manufacturing and packaging sites to accurately identify, document, and resolve issues in compliance with company procedures and regulatory requirements.
- Verify complaint accuracy and completeness before assigning cases to the appropriate investigation site(s).
- Evaluate returned samples to support investigation conclusions.
- Review batch records for relevant data and evidence.
- Drafted comprehensive investigation reports for internal review and approval, facilitating informed decision-making.
- Ensured product quality through systematic evaluations and audits, and contributed to compliance and risk mitigation.
Manager, Product Complaints
2 Years- Lead product complaint activities ensuring GMP/GCP quality and regulatory compliance across systems/processes.
- Prepared, reviewed, and approved internal and external reports and documentation for regulators/customers, supporting effective QA complaint function.
- Summarized complaint investigations for management review and approval, ensuring clarity and actionable insights.
- Coordinate complaint investigations with internal stakeholders and external parties.
- Partner cross-functionally to increase effectiveness of the complaint-handling process.
- Identified and communicated opportunities for improvement in product complaints/device support processes, facilitating best practice sharing among stakeholders.
- Aid in establishing/maintaining an effective Quality System aligned with applicable international/national standards/regulations/guidelines.
Sr. Product Complaint Specialist
1 Year 8 Months- Review complaint intake details/enter complaints into Veeva Vault ensuring accurate/thorough intake information per Instructions for Use (IFU).
- Identify the need for manufacturing and/or packaging batch record reviews to support product quality complaint investigations.
- Ensured proper selection of commercial device replacement/component needs based on IFU requirements while supporting patient follow-up/troubleshooting according to IFU guidance.
- Notified external partners/suppliers of product complaints and coordinated necessary product-compliant investigations internally and externally.
- Collaborated with colleagues across departments to enhance quality assurance processes, ensuring compliance with industry standards.
- Delivered PQC program troubleshooting training to internal and external partners as requested by the Global Manager.
- Liaise with Data Safety/Pharmacovigilance group regarding adverse event identification within/outside product complaints;
- Key Results: Successfully exceeded 95% investigation/compliant closure rate within the timeframe.
Product Complaints Associate
1 Year 1 Month- Review complaint intake details and enter cases into Veeva Vault, ensuring accurate, complete information, correct selection of commercial device/component replacement needs, and appropriate patient follow-up and troubleshooting in accordance with the Instructions for Use (IFU).
- Determine when manufacturing and/or packaging batch record reviews are required to support product quality investigations; notify external partners/suppliers of relevant complaints and request investigation support when needed.
- Coordinated with Data Safety/Pharmacovigilance regarding adverse events; identified potential adverse events within product complaints and supported AE/PQC reconciliation activities.
- Identified opportunities to enhance product complaint handling and device support processes; shared best practices with Patient Support & Quality teams.
- Provide PQC program training and troubleshooting/handling guidance to internal and external partners as requested by the Global Manager.
- Collaborated with colleagues across departments to ensure compliance with quality standards in processes. effectiveness.
- Supported preparation of monthly quality metrics and reconciliations to track performance.
- Key Results: Successfully exceeded 95% investigation/compliant closure rate within the timeframe.
- Quality Assurance
Quality Specialist
1 Year 8 Months- Oversaw quality assurance processes within the department, ensuring compliance with regulatory standards and improving product quality outcomes.
- Captured, reviewed, and analyzed product complaints; initiated and coordinated investigations to resolve issues promptly.
- Complied with relevant global product quality-related guidelines, standards, and regulations regarding the receipt, review, investigation, and reporting of product experiences.
- Collaborated with Field Service, Quality, Engineering, and Operations personnel to ensure timely processing of complaints, enhancing overall response efficiency.
- Identify the differences between product quality complaints, adverse events/incidents, medical information requests, customer feedback, and regulatory agency requests.
- Consulted Regulatory Affairs management regarding potential risks or deficiencies requiring corrective action.
- Submit device Vigilance Reports for US/EU.
- Key Results: Exceeded 95% investigation and complaint closure rate timeframe; achieved zero late regulatory authority responses/MDR reporting.
Complaint Project Manager
3 Years 5 Months- Led team of clinical staff, project management resources, and engineering personnel to improve handling of medical device and treatment planning software complaints.
- Managed product complaint process, implementing cross-functional teams to troubleshoot issues and mitigate future risks.
- Consulted Regulatory Affairs management to evaluate risk-significant complaints for corrective action.
- Served as liaison with Legal group, ensuring documentation compliance with procedures and regulations.
- Participated in internal and external audits.
- Key Results: Successfully exceeded >75% investigation/compliant closure rate timeframe Achieved zero late regulatory authority responses/MDR reporting
- Regulatory/Quality Assurance Department
Senior Product Surveillance Specialist
12 Years 6 Months- Managed the complaint process from inception through resolution as the organization's initial point-of-contact for all product complaints.
- Escalated complex technical inquiries through collaboration with channel owners/stakeholders based on product knowledge and case complexity workflows.
- Designed and implemented a Complaint Handling module/database to enhance business processes and workflows, including training initiatives aligned with QMS operations.
- Contributed to needs analysis and implementation of staff training software tools/resources to support QA operations and readiness tasks; designed and implemented Complaint Handling database that improved compliance closure timeliness.
- Maintained comprehensive database tracking of customer contacts/responses/final actions throughout lifecycle tracking processes/business workflows/tools/resources used internally.
- Oversaw quality assurance operations within the department.
Education
MBA | Master of Business Administration - Business Administration
Bachelor of Science - Business Administration
Skills
Product Complaint Handling; GMP/GCP Compliance; Investigation Coordination; Case Documentation & Audit Readiness; Veeva Vault; Salesforce CQ; Quality Metrics & Reconciliations; Adverse Event Identification/Support Risk Management; Root Cause Analysis Support (RCA); CAPA Support Training & Development; Cross-Functional Collaboration (QA/QMS
Manufacturing/Op
Regulatory/Safety)
Regulatory compliance
Regulatory Compliance
Complaint management
Quality assurance
Certification
Corrective Action Preventive Action (CAPA) Training Certificate, Paralegal Certificate, Complaint Handling Qualified Trainer Certificate, Human Resources Management Graduate Certificate
Timeline
Manager/Lead Associate Product Complaints
Dr. Reddy's Laboratories
02.2024 - 08.2026Read More
Manager, Product Complaints
Insmed Inc.
02.2024 - 02.2026Read More
Sr. Product Complaint Specialist
Insmed Inc.
06.2020 - 02.2022Read More
Product Complaints Associate
Insmed Inc.
05.2019 - 06.2020Read More
Quality Specialist
Flowonix Medical
09.2017 - 05.2019Read More
Complaint Project Manager
Varian Medical Systems
10.2013 - 03.2017Read More
Senior Product Surveillance Specialist
GE Healthcare
04.2001 - 10.2013Read More
University of Phoenix
MBA | Master of Business Administration from Business Administration
Read More
University of Phoenix
Bachelor of Science from Business Administration
Read More