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Compliance Director Resume

San Francisco, CA

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.

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