What are the responsibilities and job description for the Director Office of Compliance and Biologics Quality position at FDA?
Duties
Summary
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 8, Band G..
Requirements
Qualifications
In order to qualify for the Director Office of Compliance and Biologics Quality position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/22/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both. Technical Requirements: You do not need to provide narrative responses. This qualification should be reflected in your 2-page resume. Demonstrated knowledge and experience in the regulation and development of biological products, including the evaluation of safety, effectiveness, and product quality. Desirable Qualifications: An advanced degree from an accredited college or university, in a field related to the medical field, health sciences or allied sciences appropriate to the work of the position. Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review. Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same. Provides reasonable accommodations needed to best utilize qualified people with disabilities. Organizational Management: Program Management: Resource Management: Personnel Performance Management: Human Capital Management: This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes. Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. All requirements must be met by the closing date of this announcement (07/22/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.
Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), in the Office of Compliance and Biologics Quality (OCBQ) in Silver Spring, MD. The mission of the Center for Biologics Evaluation and Research is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
Summary
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 8, Band G..
Requirements
Qualifications
In order to qualify for the Director Office of Compliance and Biologics Quality position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/22/2026: The candidate must meet the following qualifications for this Title 21 position: Scientific, Technical, and/or Professional Fields Qualified and Outstanding Candidates a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both. Technical Requirements: You do not need to provide narrative responses. This qualification should be reflected in your 2-page resume. Demonstrated knowledge and experience in the regulation and development of biological products, including the evaluation of safety, effectiveness, and product quality. Desirable Qualifications: An advanced degree from an accredited college or university, in a field related to the medical field, health sciences or allied sciences appropriate to the work of the position. Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review. Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same. Provides reasonable accommodations needed to best utilize qualified people with disabilities. Organizational Management: Program Management: Resource Management: Personnel Performance Management: Human Capital Management: This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes. Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. All requirements must be met by the closing date of this announcement (07/22/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.
Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), in the Office of Compliance and Biologics Quality (OCBQ) in Silver Spring, MD. The mission of the Center for Biologics Evaluation and Research is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.