Title 21 Vacancy Announcement

U.S. Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER)

Office of Pharmaceutical Quality (OPQ)

Office of Product Quality Assessment (OPQA)

Division of Product Quality Assessment XVII and XVIII (DPQAXVII)

Application Period: January 29, 2024 – February 9, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. 

National. Foreign nationals or legal permanent residents are not eligible for consideration.

Commissioned Corp Officers are eligible to apply. Appropriate for O-6 billet.

Position: Division Director Series: AD-0601

Location(s): Silver Spring, MD

Work Schedule: Full Time

Salary: Starting at $177,123

Cures Band(s): Band F Full Performance Band Level: Band F

Travel Requirements: 25% or less

Bargaining Unit: 8888

Relocation Expenses Reimbursement: Will not be paid. 

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 

21st Century Cures Act. The candidate selected for this position will serve under a career or 

career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and 

consumer protection agency responsible for ensuring all human and animal drugs, medical 

devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing 

animals, tobacco and radiation emitting devices safe, and effective.
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The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential 

public health task by making sure that safe and effective drugs are available to improve the 

health of people in the United States. CDER regulates the over the counter (OTC) and 

prescription drugs, including biological therapeutics and generic drugs.

The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of 

human pharmaceutical quality within CDER, including submission review, manufacturing facility 

assessment, and surveillance of the quality of marketed pharmaceutical products. 

The Offices of Product Quality Assessment (OPQA) III evaluate and assess product quality 

aspects over the product lifecycle for all types of human drug product applications, including 

Investigational New Drugs (INDs), Biologics Licensing Applications (BLAs), New Drug 

Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Active Pharmaceutical 

Ingredients (API) information supporting these applications, and make risk-informed 

recommendations on the approvability of such products and evaluates and assesses postmarketing activities for these drug products.

Duties/Responsibilities

As a Division Director, the incumbent plans and directs activities and oversees the scientific 

review and quality evaluation of applications assigned to the Division. Advises Office of 

Pharmaceutical Quality OPQ,CDER, and other Centers (including Office of Regulatory Affairs) on

scientific and regulatory issues associated with pharmaceutical quality.

• Directs the evaluation and assessment of pre-marketing and post-marketing activities 

for INDs, BLAs, NDAs, or ANDAs; and monitors, oversees, and coordinates the 

performance of team-based reviews that include cross-office collaboration and 

participation in inspections.

• Develops and oversees the execution of strategies involving application review and 

ensures the consistency of regulatory decisions.

• Develops and oversees the execution of strategies involving the pre- and post-approval 

assessments.

• Directors the operational management of the division, including budget, hiring, and 

training of staff.

Supervisory Responsibilities: Provides leadership and management oversight to subordinate

staff. Supervises and evaluates staff supervisors who serve as experts in their field. Provides 

occupational specific technical and administrative direction and supervision 25 percent or more 

of the time to subordinate staff performing the work and functions of the organizational unit. 

Reviews and approves or disapproves subordinate supervisors and staff’s leave requests. 

Obtains and identifies strategic objectivesfor the organization.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
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• Employment is subject to the successful completion of a background investigation, 

verification of qualifications, completion of onboarding forms, submission of required 

documents, and any other job-related requirement before or after appointment.

• Applicants must meet all qualification requirements by the closing date of this 

announcement. 

• Direct Deposit: You will be required to have all federal salary payments electronically 

deposited into a bank account with a financial institution of your choice.

• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will 

be processed through e-Verify to determine your employment eligibility. If a discrepancy 

arises, you must take affirmative steps to resolve the matter.

• Males born after December 31, 1959 must be registered with the Selective Service.

• One-year supervisory probationary period may be required. 

• Financial Disclosure may be required.

• Ethics Clearance may be required. 

• Background Investigation/Security Clearance is required. All employees must pass a security 

investigation. Failing to pass the background check may be grounds for removal or legal 

action. If hired, you may be subject to additional investigations at a later time.

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use 

the basic requirements defined in the OPM Qualification Standards 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.

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required

qualifications. Please note: Additional education and experience listed that is not indicated as 

required is preferable and desired. Candidates who do not meet the “desired” criteria will not be 

excluded from consideration for this position. 

Title 21 Minimum Qualifications:

Education: A bachelor’s degree or higher in pharmaceutical science, pharmaceutical 

engineering, pharmacology, chemistry, biology, microbiology, chemical engineering, 

biochemical engineering, pharmacy, biochemistry, molecular biology, physical sciences, life 

sciences, engineering, mathematics, PharmD, biological sciences, agriculture, natural resource 

management. The degree must be from an accredited program or institution.
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Position’s Desired Skills, Experience, or Education:

Our ideal candidate will possess:

• Significant experience in identifying, articulating, addressing, and resolving unique, farreaching and/or previously unresolved and precedent-setting problems and complex 

issues.

• Demonstrated skill in applying leadership principles and concept, managing, and leading 

a diverse interdisciplinary staff.

• Excellent communicator with strong interpersonal skills.

• Demonstrated managerial experience in diverse organization.

• Ability to develop networks and build alliances. Experience collaborating across 

boundaries to build strategic relations and achieve common goals.

• Ability to identify internal and external politics that impact the work of the organization.

• Ability to identify and analyze problems, weighing relevance and accuracy of 

information, to evaluate alternat solutions and make recommendations. 

• Experience in organizational change management.

• Ability to communicate with various audiences effectively and efficiently with varying 

levels of domain expertise.

• Demonstrated success in implementing information management systems that 

effectively meet business needs.

• Ability to work independently and as a contributing, productive, and collaborative team 

member.

• Skillful in project management.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often 

have very specific educational requirements. A transcript is required to verify educational 

achievement. Pay careful attention to the Qualifications and Education sections to identify 

vacancies where a transcript is required. Even if you hold a similar position or are a current FDA 

employee, you are not exempt from transcript requirements.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities 

to meet the qualification requirements, you must show that the education credentials have 

been evaluated by a private organization that specializes in interpretation of foreign education 

programs and such education has been deemed equivalent to that gained in an accredited U.S. 

education program; or full credit has been given for the courses at a U.S. accredited college or 

university. For more information about this requirement, please visit the U.S. Department of 

Education website for Foreign Education Evaluation. 

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Non-Sensitive/High Risk
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A background security investigation will be required for all appointees. Appointment will be 

subject to the applicant’s successful completion of a background security investigation and 

favorable adjudication. Failure to successfully meet the requirements may be grounds for 

appropriate personnel action. In addition, if hired, a background security investigation or 

supplemental investigation may be required later.

Applicants are also advised that all information concerning qualification is subject to 

investigation. False representation may be grounds for non-selection and/or appropriate 

disciplinary action.

Ethics Clearance Requirements

This position may require 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. 

Equal Employment Opportunity 

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of race, color, 

religion, sex (including pregnancy and gender identity), national origin, political affiliation, 

sexual orientation, marital status, disability, genetic information, age, membership in an 

employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where 

appropriate. Applicants requiring reasonable accommodation for any part of the application 

process should follow the instructions in the job opportunity announcement. For any part of 

the remaining hiring process, applicants should contact the hiring agency directly. 

Determinations on requests for reasonable accommodation will be made on a case-by-case 

basis. A reasonable accommodation is any change to a job, the work environment, or the way 

things are usually done that enables an individual with a disability to apply for a job, perform 

job duties or receive equal access to job benefits. 

Under the Rehabilitation Act of 1973, federal agencies must provide reasonable 

accommodations when: An applicant with a disability needs accommodation to have an equal 

opportunity to apply for a job. An employee with a disability needs accommodation to perform 

the essential job duties or to gain access to the workplace. An employee with a disability needs 

accommodation to receive equal access to benefits, such as details, training, and officesponsored events. You can request a reasonable accommodation at any time during the 

application or hiring process or while on the job. Requests are considered on a case-by-case 
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basis. Learn more about disability employment and reasonable accommodations or how to 

contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility 

Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of 

new hires and the validity of their Social Security numbers.

How to Apply

All qualified candidates will access a virtual interview platform via HireVue where you will be 

directed to record answers to screening questions. Recordings to all questions must be 

complete before the conclusion of the announcement period for application packages to be 

considered completed. Your recorded answers and resume should be uploaded to your HireVue

profile by February 9, 2024. 

Please send copies of your transcripts to OPQ_Cures_Recruitment@fda.hhs.gov not later than 

February 9, 2024. If you have foreign transcripts, please submit the foreign transcript courseby-course evaluation from an accredited company (NACES or AICE). Candidate resumes may be 

shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of 

this process by annotating resume with “do not share”. 

Please reference Job Reference: OPQAIII Division Director in the email subject line.

How You Will Be Evaluated

Candidates may be evaluated based on an interview, review of requested work samples, writing 

samples, most recent performance evaluation(s), professional references, results of an oral 

presentation or work-related test. Failure to comply with any of the additional assessment 

requirements will result in removal from further consideration.

Announcement Contact

For questions regarding this Cures position, please contact

OPQ_Cures_Recruitment@fda.hhs.gov. 

The U.S. Department of Health and Human Services is an equal opportunity employer with a 

smoke free environment.

FDA is an equal opportunity employer.