Open to opportunities

Donna Churchill

@donnachurchill

Message

Experienced Quality Assurance professional in the Pharmaceutical industry.

United States

Message

What I'm looking for

I am seeking a role that fosters continuous improvement and regulatory excellence.

I am a seasoned Quality Assurance professional with over 25 years of experience in the Pharmaceutical and Biopharmaceutical industry. My expertise lies in managing quality systems, ensuring regulatory compliance, and overseeing vendor management. I have a proven track record of implementing effective quality strategies that adhere to FDA guidelines, cGMP environments, and eQMS systems. My strong leadership skills focus on continuous improvement and maintaining inspection readiness, which has been pivotal in my roles.

In my most recent position as Associate Director Quality CMC at Blaze Bioscience Inc., I led cross-functional teams as a Quality Subject Matter Expert, developing process control strategies and performing risk assessments. I directed the review and approval of CMC Quality events and regulatory submissions, ensuring strict adherence to FDA guidelines. My previous roles have equipped me with a comprehensive understanding of quality assurance processes, from managing pharmacovigilance programs to conducting compliance audits and streamlining documentation systems.

Experience

Work history, roles, and key accomplishments

Associate Director Quality CMC

Blaze Bioscience Inc.

Aug 2021 - Jan 2025 (3 years 5 months)

Led cross-functional teams as Quality SME, developing process control strategies and performing risk assessments. Directed the review and approval of CMC Quality events, ensuring adherence to FDA guidelines.

Quality Management FDA Compliance Risk Assessment SOP Development Vendor Management

QA Product Manager

Catalent Pharma Solutions

Apr 2018 - Aug 2021 (3 years 4 months)

Acted as the primary quality liaison for clients, ensuring compliance with FDA, ICH, and EMA guidelines. Coordinated project functions to enhance overall quality system performance.

Quality Assurance Regulatory Compliance Project Coordination Change Control Audit Management

Manager Regulatory Affairs & Compliance

WellSpring Pharmaceutical Corporation

Aug 2014 - Apr 2018 (3 years 8 months)

Managed pharmacovigilance program and ensured compliance with FDA and other regulatory guidelines. Conducted quality compliance audits of suppliers and maintained stability programs.

Regulatory Affairs Supplier Management Quality Assurance

GLP/GCP Quality Assurance Officer III

Covance, Inc.

Mar 2013 - Aug 2014 (1 year 5 months)

Conducted inspections to ensure compliance with GCP, GLP, and other regulatory standards. Acted as QA liaison for multiple sites, facilitating inspections and training.

GLP GCP Quality Assurance SOP Development Training Regulatory