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Director, Office of Process and Facilities within the Office of Pharmaceutical Quality

FDA


Location:
Silver Spring, Maryland
Date:
04/06/2018
2018-04-062018-05-06
Job Type:
Employee
Job Status:
Full Time
FDA
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Job Details

 

Position: Director, Office of Process and Facilities (OPF)

 

Series: This is an interdisciplinary, scientific position that may be filled in the biological sciences or health sciences

 

Location: Silver Spring, MD

 

Salary Range: Salary is commensurate with education and experience.

 

Area of Consideration:  Applications will be accepted from all highly qualified Candidates

 

Special Notes: This position will be filled as a Title 42 209 (f) appointment. This is an Excepted Service position under Title 42. This appointment does not confer any entitlement to a position in the competitive service and no entitlement to Merit Systems Protection Board (MSPB) appeal rights.

 

Conditions of Employment: United States Citizenship Required

 

Ethics Requirements: This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Disclosure Report (OGE 450) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.

 

 

 

Security and Background Requirements: If not previously completed 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 these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security investigation or supplemental investigation may be required at a later time. 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.

 

This position is for the Director, Office of Process and Facilities (OPF), located in the 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 Process and Facilities (OPF).The Director for Office of Process and Facilities position provides the opportunity to direct all matters under the purview of OPF and assumes full responsibility for its proper functioning and operation. Provides leadership, oversees and directs review programs and policies within OPF and manages Review and Operations within the Office of Process and Facilities (OPF), which includes planning, developing, executing, administering, coordinating, managing and directing the office review and inspection activities as they relate to IND, NDA and ANDA applications, covering the manufacturing process and controls, and facility inspections of these drugs that are intended for human use.

 

Duties/Responsibilities:

 

As the Director, Office of Process and Facilities (OPF), you will be responsible for providing leadership and direction over the Quality Assessment programs and for the implementation of policies within OPF, including planning, developing, executing, administering, coordinating, managing and directing the office review and inspection-support activities.  Major duties and responsibilities will include:

 

  • Overseeing the planning, direction, implementation, administration, evaluation and timely execution of OPF's programs involving the scientific and technical evaluation of drug manufacturing operations.
  • Advising the Director of OPQ and key Office/Center officials on operational activities affecting programs, projects and initiatives.
  • Collaborating with key agency officials to identify needs pertaining to areas within OPF's scope and ensuring that policies, programs priorities, goals legislated objectives and regulatory requirements are achieved.
  • Providing scientific leadership and management direction to a multidisciplinary scientific and professional staff who oversee scientific review, and quality evaluation of manufacturing process, and facilities for human drug applications.
  • Developing and implementing office-wide goals and objectives in response to policy changes, budgetary restraints and other statutory or program changes.
  • Providing leadership and direction over the Quality Assessment programs and for the implementation of policies within OPF.
  • Providing direct administrative and technical supervision to a multidisciplinary scientific and professional staff.
  • Reviewing program accomplishments for consistency of approach and alignment with agency procedures and policies.

Qualifications:

 

  • Candidates must meet the minimum qualification requirements for the GS-15 or beyond in the civil service General Schedule and must have a strong scientific background and managerial experience. 

 

In addition, for this specific position, applicants must meet the following:

 

Mandatory Professional/Technical Qualifications: -

 

 

 

Candidates must have a doctoral-level degree from an accredited institution of higher learning, including:

 

  • Ph.D. or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph. D.;
  • A doctoral level knowledge of chemistry or related fields;
  • Extensive knowledge of the development of human drugs, including statutory requirements, appropriate Agency guidance, and regulatory processes.
  • Transcripts are a requirement to support the Ph.D.

 

Mandatory Managerial/Executive Qualifications:

 

Candidates must have the ability to bring about strategic change, both within and outside the organization, to meet organizational goals; the ability to lead people toward meeting the organization's vision, mission, and goals:

 

  • Ability to meet customer expectations;

  • Ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals;

 

  • Background and understanding of pharmaceutical process and facility;
  • Process background on Research and Development and manufacturing level;
  • Experience in a pharmaceutical manufacturing facility;
  • Fluent understanding of the manufacturing language;
  • Understanding of multiple drug areas (Biologics, NDAs, Generic);
  • Experience with inspection (understanding FDA inspection);
  • Ability to handle technical and other issues;
  • Strong leadership capability;
  • Ability to manage very large teams;
  • Ability to collaborate well within and outside of the organization;
  • Flexibility with changing philosophies;

 

 

 

Desirable Qualifications:

 

Candidates should have:

 

  • Executive level administrative or managerial experience that demonstrates sound judgment, strong leadership abilities in a scientific or public health environment;
  • Demonstrate leadership competence and abilities to:
    • develop complex and basic program goals, and assure that agency goals and priorities are considered in carrying out and completing OPF's responsibilities;
    • direct and guide projects, including long-term and short-range planning;
    • establish objectives and priorities;
    • conduct periodic program assessments;
    • plan and direct the work of a large scientific review staff;
  • Experience indicating the ability to communicate and effectively interact with high level government officials, the scientific/academic communities, medical or health related organizations, members of congress and top level representatives of counterpart Federal agencies, foreign government, officials, CEO level and senior representatives from regulated industry, and other stakeholders.

 

 

 

It is desirable that candidates have:

 

  • Extensive knowledge in drug product development and manufacturing;
  • Practical knowledge of the application of FDA laws and regulations;
  • Training, professional development, and outside activities that provide evidence of initiative, resourcefulness and potential for effective job performance such as invitations, presentations and international activities;
  • Receipt of honors, awards or other recognition for performance or contributions based on managerial excellence;
  • Professional leadership activities;
  • Technology transfer and service experience;

 

 

 

Application Procedures:

 

Candidates must submit a CV and transcripts to Whitney Flickinger: CDERExecutiveRecruiting@fda.hhs.gov

 

 

 

FDA is an equal opportunity employer

 

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