Compliance Director Resume San Francisco, CA - Hire IT People

SUMMARY:

Over 15 years of regulated pharmaceutical software validation and quality experience, ensuring compliance with regulatory frameworks, industry guidance/ best practices, and internal regulatory policies.
Substantial experience in implementing systems from conception to retirement, while providing innovative and sound guidance.
Experienced with implementing coherent, and logical processes both locally and globally.
Self - motivated team player that works effectively with cross functional teams on projects and organizational process improvement initiatives.
Strong scientific and pharmaceutical business knowledge.

KNOWLEDGE BASE:

Laboratory software: Waters Millennium32 / Empower | Molecular Devices SoftMax | Applied Biosystems Analyst

LIMS: LabWare | LabVantage | Thermo Watson

Quality and support systems: Valgenesis | HP Quality Center | Livelink | Agilent OpenLAB

EXPERIENCE:

Confidential

Compliance Director, San Francisco, CA

Responsibilities:

Develop compliance policies to meet good engineering practices.
Ensure adherence to policies by providing quality oversight of Confidential SaaS software applications.
Oversee testing team to ensure compliance to established procedures.
Provide external customer audit support, validation guidance for software used in a regulated healthcare SaaS model, and employee .

Confidential

Senior Business Analyst, Berkeley, CA

Responsibilities:

Validation lead for LabVantage LIMS upgrade (QC laboratory): Assessed business processes, developed validation strategy.
Responsible for implementing changes for various systems, including MES.
Provided guidance and reviewing quality management system procedures.

Confidential

Senior Validation Engineer, San Francisco, CA

Responsibilities:

Designed an integrated global computer system validation processes, including an integrated risk assessment, software development life cycle and retirement process; developed material and performed global .
Provided QA support by reviewing and approving validation risk documentation, system related documentation, and test strategy documentation (SAP, TrackWise, Salesforce). Oversaw independent contractors.

Confidential

Consultant

Responsibilities:

Responsible for administration and change management activities for Watson LIMS and SoftMax Pro.
Validation projects included Applied Biosystems Analyst upgrade involving project management, oversight of contractors, vendors, movers, and quality assurance during instrument moves.
Deployed Watson application to multiple sites via Citrix.
Team member for a corporate initiative to in corporate GAMP.

Confidential, Rockville, MD

Laboratory Systems Administrator

Responsibilities:

Validation lead responsible for the implementation of LabWare LIMS and Waters Millenium32 and Empower Client/Server, including authoring validation documents, standard operating procedures and materials.
Laboratory system administrator responsible for change management of all lab computer systems.
Coordinated activities across QA, IT and various business groups.

Research Chemist

Confidential

Responsibilities:

Developed and validated analytical assay methods via HPLC, Dissolution, and UV-Vis.
Performed product quality and excipient testing (GMP/GLP environment) in accordance with SOPs and the USP/NF.
Calibrated and maintained laboratory equipment including HPLCs, Dissolution units, freezers, and stability chambers.