Optimizing Performance & Enhancing Compliance

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Paul is an outstanding leader with a wealth of experience in the pharmaceutical industry. His in-depth knowledge in areas of Quality, Regulatory and Drug Safety, plus his personable traits make Paul an effective expert in compliance resolution who naturally engages stakeholders across different facets of the organization to meet aggressive project timelines.

- Elena

Paul is an excellent resource for Quality Systems (Medical Device and Pharma) knowledge and experience. He has the ability to evaluate a quality system holistically; identifying gaps and providing customer driven solutions in system interactions to improve the robustness of the entire Quality System. His working knowledge of customer interactions, risk management and Pharmacovigilance enables him to translate field issues into solutions, whether at the manufacturing sites or changes in instructions for use. His expertise in design control and in various design control elements has helped improve the design control process for medical device and pharmaceutical products, resulting in expedient product launches. During my tenure with Paul, I have learned that he has great interpersonal skills and works well with people at all levels with the organization, including regulatory agencies.

- Rubik

It has been my great pleasure to work with Paul on several critical projects and to get to know him personally. Paul has a deep understanding of quality systems, global regulations, and the medical device development process. He is my “go to” resident expert and his leadership, expertise, and sense of humor are invaluable to quickly resolve challenging issues. Paul is a thoughtful and strategic leader, with a comprehensive view of the organization. Paul leverages his broad business perspective and quality process knowledge to identify gaps and work across organizational boundaries providing solutions to achieve success for the company. This is an incredible strength to bring to any organization.

- Elizabeth

I would like to recommend Paul for his outstanding ability to understand pharmacovigilance and quality assurance. Having a background in both areas, he is able to create interfaces between the two groups that work really well, from an operational perspective (which is challenging, given the different nature and objectives of the organizations) and from a scientific perspective in mining pharmacovigilance data to generate meaningful insights into pharmaceutical quality and vice versa (which is even more challenging). I have worked with Paul while at Amgen on a number of interface issues between PV and QA and found him to be not only a very capable scientist and manager but also a very collegial and charming person. His engagement in preparing a pharmacovigilance inspection was critical to the success of this effort, as far as the PV-QC interface was concerned. He did set p a reporting process that aligned the needs of safety and quality and built strong relationships with the safety scientists to evaluate signals in the PV-QC interface. I am happy to provide additional information on the successful collaboration with Paul and would recommend him without reservation for his outstanding professional and personal characteristics.

- Peter

Just to say thank you for all your help earlier in the year it was much appreciated and your advice helped us a great deal. Thank you for your fantastic help and advice this year. Your advice made a significant difference, especially speed to market. I look forward to working with you again

- Julie and Trevor