Heather Dowd Email & Phone Number

Apex, North Carolina, US

Build, implement, and manage companywide Quality Management SystemCreate and lead Project Quality team in execution of quality management processes across all sitesSupport quality related aspects of new site integration and vendor managementLead and prepare sites for sponsor audits and inspections

Silver Spring, Maryland, US

Perform regulatory CMC and labeling activities for assigned products and territories, creating and updating quality sections of regulatory filings.Collaborate with internal manufacturing and quality groups, and contract and partner organizations regarding CMC and labeling regulatory issues.Assist in dossier preparation for partner companies in worldwide.

Durham, North Carolina, US

• Portfolio Quality Lead for a key global partnership, providing quality and regulatory consultation and oversight, acting as Quality Lead of Operational Steering Team and as liaison between all Early Phase (EP) Clinical.
• Support Clinical Unit Quality Management and study teams with issue escalation, regulatory assessment and reporting, CAPA and RCA processes.
• Serve on regulatory intelligence (RI), governance, and compliance committees, contributing to RI database, identifying regulatory changes requiring action, and advising on process changes, implementation, and.
• Quality Review Board member providing regular updates to upper management of key regulatory requirements, changes, considerations, and recommendations.
• Monitor project team compliance with GxP guidelines/regulations, providing consultation on regulation implementation.
• Identify and evaluate potential project-level risks and quality issues and determine prevention and mitigation measures; advise teams on action plans to ensure regulatory compliance.

Durham, North Carolina, US

• Provided quality oversight to operational and quality project team management.
• Participated in study document creation and review, focusing on technical consistency, quality control, and regulatory compliance.
• Monitored compliance with GxP guidelines/regulations.
• Supported key clients to ensure quality project oversight and training compliance.
• Identified and evaluated potential quality risks, gaps, and issues and worked with study and quality teams to prevent and mitigate.
• Served on regulatory intelligence and oversight governance committees.

Durham, North Carolina, US

• Supported identification, management, and prevention of project quality issues.
• Monitored processes for gaps and improvement opportunities, supporting process review and re-engineering.
• Participated in Standard Operating Procedure and associated documentation creation, review, and maintenance, liaising with EP SMEs as required for process owner guidance/contributions.
• Supported global regulatory oversight to ensure processes adapted with regulatory changes.
• Provided GxP and process expertise to operational groups.
• Created and maintained EP study team training programs and provided metrics regularly to management with root cause analysis when needed.

San Diego, California, US

• Conducted chemical and microbiological testing (final release, in-process, raw materials, stability) according to USP/compendial methods and in-house SOPs.
• Accurately documented all laboratory work according to GLP requirements.
• Trained colleagues on chromatography instrumentation (HPLC/UHPLC/GC), microbiological testing methods and titration assays, including results analysis and troubleshooting.

Raleigh, North Carolina, US

• Received, reviewed, and summarized disciplinary hearing transcripts for Board members.
• Guided board-certified Anesthesiologists through the newly created Maintenance of Certification (MOCA®) process and requirements.
• Maintained documentation, tracking, and metrics for compliance with MOCA® program.
• Created program SharePoint sites for internal team use.
• Trained Analysts on Microsoft Office products and SharePoint team sites.

New York, NY, US

• Built a solid record of achievement and advancement through increasingly responsible company positions.Operations Manager 2003 – 2006
• Managed all administrative support for domestic and offshore offices.
• Maintained, analyzed, and reconciled company entities’ accounts, shareholder registries, and fund financial statements.
• Acted as primary contact for administrative communications, assisting Managing Director in communications with high net worth clients in the U.S. and Europe.
• Proposed and implemented company-wide remote online data backup system. Reviewed vendor proposals, negotiated terms and pricing, installed software on all office computers and trained employees in use of.
• Managed Administrative Assistant and oversaw all New York office functions.

Master Of Science In Health Sciences, Regulatory Affairs

Bs Clinical Research Administration, Clinical Research

Associate’S Degree, Biopharmaceutical Technology

Associate’S Degree, Legal Assistant Studies

Grande Diplome - Pastry Studies