Ramadas Bhat

CEO

Carlsbad, California, United States41 yrs 3 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

Over 30 years of expertise in Quality Assurance.
Managed budgets exceeding $5M with significant cost savings.
Led successful regulatory inspections and compliance initiatives.

Stackforce AI infers this person is a Quality Assurance expert in the Biotechnology and Pharmaceutical industries.

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Skills

Core Skills

Quality AssuranceRegulatory ComplianceProduct DevelopmentAnalytical Chemistry

Other Skills

GMPGLPGCPQuality ControlRegulatory AffairsChange ControlQuality SystemsValidationDiscrepancy ManagementProduct SpecificationsMethod DevelopmentBiotechnologySopChromatographyPharmaceutical Industry

About

Experienced executive with over 30 years of expertise in Quality Assurance and Quality Control directing licensed commercial and clinical products. Several years of expertise in managing CMOs, Product Development (Phase I clinical to Product Licensure), Technology Transfer, Discrepancy Management, Validation, Risk Management, QA CMC, Change Control, API Releases, QC Assay Development, and Assay Validation for international in multi-billion dollar corporations. Establish QA systems and practices as vital part of product life cycle management processes. Administer budgets topping $5M, driving 6-figure cost savings per year. Manage external regulatory inspections by world-wide agencies, craft responses to transition company out of warning letters and compliance hold situations due to FDA and EMA inspections.

Experience

41 yrs 3 mos

Total Experience

10 yrs 6 mos

Average Tenure

14 yrs 3 mos

Current Experience

Ionis pharmaceuticals (formerly isis pharmaceuticals)

2 roles

Executive QA Director

Jan 2012 – Present · 14 yrs 3 mos · Carlsbad, CA

Quality and Compliance oversight of GMP, GLP and GCP functions managing clinical development as well as commercial manufacturing of APIs

GMPGLPGCPQuality AssuranceQuality ControlRegulatory Compliance

Executive QA Director

Jan 2012 – Present · 14 yrs 3 mos · Carlsbad, CA

Key responsibilities include:
Establishment and implementation of quality systems to ensure compliance to cGMP regulations.
Providing quality oversight for the GMP facility, utility systems and manufacturing operations.
Implementation of flexible, sustainable, phase-appropriate GMP systems for early and late stage clinical development projects.
Manage internal self inspections and external supplier, CMO, CRO and Contract Lab audits including the management of inspections by the regulatory agencies and big pharma partners.
Responsible for complete quality oversight of on-going non-clinical and clinical studies to ensure compliance with applicable regulatory requirements.
Implement data integrity / data verification processes for CTD dossier leading to NDA submissions.
Prepare, plan and successfully execute regulatory inspection readiness to host routine surveillance inspection (i.e. FDA), PAI, (GMP) and GCP surveillance inspections by global regulatory agencies (GCP)

GMPGCPRegulatory AffairsQuality ControlRegulatory ComplianceQuality Assurance

Bayer healthcare

4 roles

QA Director, New Products and Contract Manufacturing

Jan 2007 – Jan 2011 · 4 yrs · Berkeley, CA

Oversee product development from early R & D phase through Phase III clinical and successful transfer to commercial production. Set up programs and Quality Plans for clinical materials and implementation of PAT / Quality by Design concepts during product development. Define QA release criteria and Quality Control testing scheme for the release of Phase I – III clinical material. Manage a department of 15 - 50 staff supporting quality oversight for Research and Development, Clinical product release, analytical method development and transfer to Quality Control, life cycle product management, QA documentation system, local and global change control systems, regulatory compliance and submission of eCTDs and Contract Manufacturing. Author, review and approve CMC sections for INDs, IMPDs and BLA/MAA including variations. Complete QA oversight of contract manufacturing for third part including QAA and establish KPIs.

Product DevelopmentQuality ControlRegulatory ComplianceChange ControlQuality Assurance

QA Director, Drub Substance/API Manufacturing (Commercial)

Promoted

Jan 2002 – Jan 2007 · 5 yrs · Berkeley, CA

Oversee Quality Systems, Discrepancy Management, resolution of Out-of-specification QC test results, Validation, Change Control, API Releases, Product Development, Technology Transfer, QC Assay Development, and Assay Validation as the manager of 30 employees. Establish QA systems and practices, including vendors and suppliers, in compliance with state-of-the-art standards, current domestic and international GMP regulations, and company requirements. Conduct technical reviews for all new and modified products prior to submission for FDA, EMEA and Health Canada approval. Administer budget and capital expenditures. .

Quality SystemsValidationChange ControlDiscrepancy ManagementQuality AssuranceRegulatory Compliance

QA Product Manager

Jan 1999 – Jan 2001 · 2 yrs · Berkeley, CA

Established in-process control, product specifications and characterization strategy to successfully transfer development process into commercial operations. Developed validation requirements for new and existing processes. Offered feedback on failure investigations and troubleshooting for issues regarding licensed products or products and processes under development. Prepared annual product reviews and Product Safety Report reviews, briefing management about trends and issues affecting product quality.

ValidationProduct SpecificationsQuality ControlQuality AssuranceProduct Development

QC/QA Development Analytical Chemistry and Carbohydrate Chemistry Manager

Jan 1992 – Jan 1999 · 7 yrs · Berkeley, CA

Designed, developed, and validated methodologies to characterize biotechnology products as a technical expert for devising testing strategies for product release and process validation. Provided scientific and technical advice to QA Director on product evaluations serving as SME for glycosylation, biochemical assays, analytical instrumentation and chromatography.

Analytical ChemistryMethod DevelopmentBiotechnologyQuality Assurance