Sheena Gerstenberger Email & Phone Number

Bothell, Washington, United States

Engaging as product quality leader with Regulatory, Process and Analytical Development and other departments for a variety of activities with multiple development products. Responsible for providing oversight for quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency/regional/local guidelines. Working as the main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle.

Bothell, Washington, United States

Management of the Vendor Qualification program at Lundbeck Seattle BioPharmaceuticals, external and internal audits, and support of harmonization initiatives and continuous improvement of Quality Systems. Founding member of the North America and Global Diversity, Equity, and Inclusion (DE&I) Councils, developing and supporting DE&I initiatives in alignment with corporate diversity goals.

Bothell, Wa

Providing oversight of the Supplier Management program; scheduling audits, conducting vendor audits, reviewing audit reports and responses, and maintaining the approved supplier lists. Scheduling and providing oversight of internal audit activities. Supporting regulatory filings with data integrity checks and participating in inspection readiness activities. Supporting Quality Council meetings and Quality Management Review meetings as needed. Member of the North America Diversity, Equity, and Inclusion Council and of the Global Diversity and Inclusion Forum

Bothell, Wa

Providing oversight of the Supplier Management program; scheduling audits, conducting vendor audits, reviewing audit reports and responses, and maintaining the approved supplier lists. Scheduling and providing oversight of internal audit activities. Supporting regulatory filings with data integrity checks and participating in inspection readiness activities. Supporting Quality Council meetings and Critical Quality Attribute Risk Assessment meetings as needed.

Redmond, Wa

Responsible for maintaining regulatory compliance of the facility used for development and manufacturing Phase I and II clinical trial material. Responsible for issuance of GMP documentation including manufacturing batch records, Standard Operating Procedures and logbooks. Review of executed manufacturing batch records and release of product batches. Providing QA support for the manufacturing of developmental bulk substance to ensure compliance with the principles and guidelines of current Good Manufacturing Practices.

Bothell, Wa

Creates and drives the internal audit schedule to support continuous improvement projects and ensure compliance to regulatory requirements and internal policies. Provides support for the deviation, CAPA, and change control programs. Supports client audits and regulatory inspections. Participates in cross-departmental continuous improvement projects.

Member of the Product Disposition Team and In-Plant Compliance Team, reviewing GMP documents, material disposition, in-plant manufacturing compliance, product change over of equipment, QA oversight of equipment maintanence,calibration, and on-boarding, and assisting in other tasks aimed to meet product release deadlines and manufacturing compliance to GMP.

Bothell, Wa

Member of the Product Disposition Team, reviewing GMP documents, material disposition, and assisting in other tasks aimed to meet product release deadlines.

Working as part of a team to present manufacturing data in easy to reference formats and performing data integrity checks.

Bachelor Of Science (B.S.), Chemistry

Activities and Societies: SU Chemistry club, SU Women's Rugby

Certificate, Regulatory Affairs Certificate: Pharmaceuticals, Completed

Certificate for Pharmaceutical Regulatory Affairs with a focus on US and EU Regulations.

Associate Of Science (A.S.), General Science Transfer Degree

Activities and Societies: Shoreline Chemistry Club President, Volunteer for Boeing Creek Water Testing