Mark C. Saale
San Diego,USA
Summary
Experience effectively supervising and managing staff Experience in multiple program areas, Import, Domestic and International Ability to effectively and diplomatically work with individuals from varying backgrounds Experience working with individuals in other FDA districts and Centers
Overview
16
16
years of professional experience
Work History
GDUFA Supervisory Consumer Safety Officer
U.S. Food and Drug Administration
10.2018 - 04.2025
- Supervised 8 Consumer Safety Officers, 6 of which are GDUPA, and a Consumer Safety Technician. The CSOs I supervised were located in different geographic areas including San Diego, Seattle and Los Angeles. Prior to the pandemic the inspections my CSOs conducted were in the foreign arena. Meeting timeframes after these inspections was sometimes challenging with short timeframes for writing reports after a three-week trip. The ability to manage time effectively was crucial to meet not only timeframes for GMP inspections, but also timeframes for preapproval inspections so a deadline wasn’t missed. There were times when all of my GDUFA CSOs were on foreign inspections at the same time. I had to make sure that I complied with all timeframes and deadlines by ensuring timely completion of the reports by the CSO and my timely review of the finished work product. During the early part of the pandemic I served as Acting Director of Investigations Branch for OPQO4 for six weeks while the DIB was on deployment assisting with COVID activities in the State of California. It was while I was acting that we implemented Remote Regulatory Assessments under 704a4. I participated with DIBs in the other divisions in creating and editing the SOP for conducting the remote regulatory assessments. In addition to the SOP, we had to have mailboxes created in Outlook for sending and receiving documents related to the RRAs so there was a centralized location where the documents could be accessed. During the pandemic, I also brought onboard several new hire CSOs and a CST. This was under unique circumstances with maximized telework. I was able to make sure they had everything needed to get started with online modules and other training during their first year. We all had to learn a new way of doing business while on maximized telework for safety to prevent the spread of COVID-19. I continue my work as a member of the Supervisory and Management Course Advisory Group for the Division of Human Resources Development. As a member of the CAG, I assisted with modifying training courses for supervisors and managers to enable some of the training to be taken online. We also developed a training course for new supervisors to familiarize them with the CBA.
- Division of Pharmaceutical Quality Operations IV/Division of Human and Drug Inspectorate VI
- Grade Level: GS-14
Supervisory Consumer Safety Officer
U.S. Food and Drug Administration
05.2014 - 10.2018
- At this location I was a supervisor in the Los Angeles District from 5/2014 – 5/2017 and a supervisor in the Division of Bioresearch Monitoring II from 5/2017 – 10/2018. I supervised 11 FDA employees including 9 Consumer Safety Officers, a Consumer Safety Technician and a student intern. Of the 9 Consumer Safety Officers I supervised, 3 were Drug Specialists, 2 were Seafood Specialists, two were Device CSOs and two were new hires. My CST was the lead CST for the district and also the District Assignment Manager. I was the BIMO program monitor for the district responsible for coordinating inspections in a program that was not a primary program area for CSOs in the district prior to Program Alignment. This involved leveraging resources from other supervisory groups with sometimes very short notice. In 2015 I served on an SME panel for the GS-13 Grade Level Elevation for Bioresearch Monitoring. In 2016 I served on an SME panel for a GDUFA hiring effort. In March of 2016 I gave three presentations covering BIMO inspections at the SoCRA conference in San Diego. As a member of the Supervisor and Management CAG with OTED, I gave three presentations in 2015 to new supervisors and managers at the Practical Applications course in Rockville. I was selected to perform a detail as Acting Director of the Investigations Branch for the Los Angeles District from November 28, 2014 through February 20, 2015. I was responsible for all of the inspectional activities of the branch and supervised first-line supervisors including 3 GDUFA supervisors. I was the Acting DIB when I received notification from the World Health Organization that a firm in our jurisdiction was manufacturing Ebola Test kits and shipping them to West Africa. We were able to convince the firm to cease manufacturing of the devices and destroy their finished devices which were unapproved. It was also during this time that there were deaths associated with individuals being infused with a non-sterile saline solution which was supposed to be used for training purposes. The firm was contracting the manufacturing of the practice solution to a firm in China. We met with the firm and they agreed to labeling changes to prevent erroneous infusions in the future. In February 2015 I was the only Acting Branch Director authorized to attend the SMT meeting where we discussed Program Alignment. I was selected to serve a detail as Acting Director of the Investigations Branch for the Los Angeles District from April 17, 2016 through May 14, 2016. During this time we initiated a follow up inspection at the IVD manufacturer that had been manufacturing Ebola Test Kits. They were now manufacturing Zika test kits. I was selected for a detail in OFFO as Acting Branch Director of the Food and Feed Program Operations Branch from September 4, 2016 through October 29, 2016. During that time, I supervised individuals from across the country and was responsible for all aspects of the human and animal feed program. I was selected to serve a detail as Acting Director of Investigations Branch for the Division of West Coast Imports from June 11, 2017 through July 22, 2017. During that time, I managed a branch with 11 supervisors on the west coast reporting to me from Seattle to Long Beach. I was the first DIB for that division and was able to standardize several procedures throughout the division. I was selected to serve a detail as Acting Director of Compliance Branch for the Division of Pharmaceutical Quality Operations IV from July 23, 2017 through January 20, 2018. During this time, I supervised six compliance officers located throughout the division. There were several regulatory actions taken by the division during my detail including warning letters, regulatory meetings and an injunction. I also attended the Senior Management Team meeting in August representing Pharma Division IV and the Pharma Director’s Meeting in September.
- Grade Level: GS-13
Supervisory Consumer Safety Officer
U.S. Food and Drug Administration
03.2009 - 05.2014
- I managed 9 FDA employees including 8 Consumer Safety Officers and a Consumer Safety Technician. My employees performed domestic and import work. In 2011 I became the senior supervisor at the resident post and served as mentor to the two new supervisors. In 2012 I became a member of the Supervisory/Management Course Advisory Group for the Division of Human Resources Development. I was selected to perform a detail in DIO as Acting Director, Import Operations and Maintenance Branch for the month of December 2013. In 2012 I was selected to assist with writing guidance for the Quality Assurance Manual for the Voluntary Qualified Importer Program. I have served as Acting Director of Investigations Branch on several occasions. I have also served as Acting District Director for SWID on several occasions. In 2012 I helped to coordinate a visit to the port by the FDA Commissioner which involved media coverage. I was assigned to respond to questions from the Mexican media. In June of 2011 and January of 2014 I coordinated visits to Otay Mesa by the ACRA. In August of 2011 I helped coordinate the agency response to an outbreak of Salmonella in papayas. In October of 2009, I assisted in developing a New Hire training curriculum to prepare SWID New hires for Basic Law and Evidence Development. Along with the Director of Compliance from SWID, I provided training to New Hires via Adobe Connect to prepare them for the Basic Law and Evidence Development course resulting in a 100% pass rate for SWID attendees. Due to the success of the training program that we cooperatively developed, DHRD requested copies of the training materials to nationally develop a Law and Evidence training program for all FDA employees who perform import work. I worked with the Los Angeles District to obtain training and inspections for SWID employees to prepare them to become members of the foreign inspection cadre. In September of 2010, I traveled to several ports along the US/Mexico border to conduct Level 1 Audits of new SWID employees. In 2010 I assumed the duties of Import Program Manager for the Southwest Import District. Over the course of the last three years in Otay Mesa we have had to coordinate responses to multiple outbreaks, recalls, medical device shortages and congressional inquiries.
- Southwest Import District
- Grade Level: GS-13
Education
Doctor of Chiropractic Degree -
Southern California University of Health Sciences
Whittier, CA05.2000
Associate Degree -
Victor Valley Community College
Victorville, CA05.1994
Skills
- Managing a division of employees with the responsibility of protecting public health according to Federal Regulations
- Monitoring of clinical research to include auditing CROs, IRBs, and Clinical Investigators to ensure compliance with regulations
- Knowledge of FDA audit and inspectional procedures to include pharmaceuticals, medical devices and bioresearch monitoring
- Giving presentations on FDA regulations to public and government officials
- Worker training
- Training and mentoring
- Regulatory compliance
- Procedure implementation
- Program activities
- Public health
- Investigations
- Team building
- Respiratory protection
- Critical thinking
Timeline
GDUFA Supervisory Consumer Safety Officer
U.S. Food and Drug Administration
10.2018 - 04.2025
Supervisory Consumer Safety Officer
U.S. Food and Drug Administration
05.2014 - 10.2018
Supervisory Consumer Safety Officer
U.S. Food and Drug Administration
03.2009 - 05.2014
Doctor of Chiropractic Degree -
Southern California University of Health Sciences
Associate Degree -
Victor Valley Community College
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