Paula Brockmeyer

Paula Brockmeyer

Paula Brockmeyer

Director

Paula draws on 25 plus years of diverse experience in the Biopharmaceutical, Pharmaceutical, and Medical Device industries to assist companies in development and compliance efforts to ensure robust quality programs, successful regulatory inspections, and maintenance of pharmaceutical, biopharmaceutical and medical device products, laboratories and facilities. She provides a full range of risk-based GMP consulting services primarily in areas of Quality Systems Regulation (QSR), Regulatory Compliance, and process improvements. She also provides Quality oversight and Global Project Management services for PC clients.

Work Experience

Paula has provided project management, scheduling and tracking on numerous projects (small and large) while concurrently providing thought leadership and subject matter expertise in these areas. Paula utilizes her broad background to assess compliance issues and develop effective, efficient, robust and comprehensive quality systems to ensure regulatory compliance. She consults with client senior management to develop effective strategies to compliance issues and performs verification activities include activities under attorney-client privilege. She assists companies in ensuring regulatory documentation is adequately implemented and maintained for quality systems, laboratory, and manufacturing operations. She has experience with Data Integrity auditing within GMP quality systems.

Prior to her current role as a director, Paula worked with KMI, a division of Parexel, where she was responsible for GMP assessments, development of SOPs; evaluation and assessment of quality systems, batch record review (verification and certification) and witnessing of pharmaceutical manufacturing; data analysis; and preparation of final reports in addition to project management oversight. Prior to working for Parexel Paula worked for biologics and medical device companies in Quality Management.

Education

Paula holds a Bachelor of Science from Iowa State University.

We are always available for a conversation.

*