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Manager Fda Consulting Jobs in Texas (NOW HIRING)

FUJIFILM Biotechnologies

... contractors and consultants working on the projects. This position will work closely with ... Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA ...

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Manager Fda Consulting information

What does a manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

How does a manager in FDA consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.

What are the key skills and qualifications needed to thrive as a manager in FDA consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

What are the most commonly searched types of Fda Consulting jobs in Texas?

The most popular types of Fda Consulting jobs in Texas are:

What are popular job titles related to Manager Fda Consulting jobs in Texas?

For Manager Fda Consulting jobs in Texas, the most frequently searched job titles are:

What job categories do people searching Manager Fda Consulting jobs in Texas look for?

The top searched job categories for Manager Fda Consulting jobs in Texas are:

What cities in Texas are hiring for Manager Fda Consulting jobs?

Cities in Texas with the most Manager Fda Consulting job openings:

Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in Texas as of August 2026, with employment types broken down into 86% Full Time, 11% Part Time, 2% Contract, and 1% Nights. Highlights an 79% Physical, 3% Hybrid, and 18% Remote job distribution.

Professor, Clinical Faculty Appointment (CFA), Laboratory Medicine

MD Anderson

Houston, TX

Full-time

Medical, Dental, Retirement, PTO

Re-posted 2 days ago

MD Anderson Cancer Center rating

8.5

Company rating: 8.5 out of 10

Based on 172 frontline employees who took The Breakroom Quiz

14th of 895 rated healthcare providers

Job description

BLOOD BANK PATHOLOGIST, DEPARTMENT OF LABORATORY MEDICINE
ACADEMIC RANK: Assistant Professor,Associate Professor, Professor, CFA (Commensurate with Experience)
SECTION MISSION: The Transfusion Medicine Section provides all CLIA and FDA-compliant services related to blood and blood product donation, testing, and processing, transfusion of blood and blood products, and the testing and evaluation of patients selected for transfusion. In addition to delivering high quality patient-care services, the Section contributes to the educational mission of the institution by providing training in a high-volume transfusion medicine service to clinical and post-doctoral fellows, as well as a wide range of other professional personnel. Research activities related to patient care and transfusion medicine services are also essential activities in the Transfusion Medicine Section.
ESSENTIAL FUNCTIONS: The candidate's major responsibilities will be to assist in oversight of operations with particular emphasis on the scientific, technical, regulatory, and interpretative activities. The candidate will assist transfusion medicine and donor services with operational clinical activities and the daily operation of a very busy transfusion medicine service. Specific activities include compliance with CMS/CLIA, FDA, OSHA, AABB, CAP, JC and relevant state statutes and regulations. The successful candidate will be involved in an intensive and active clinical consultation service providing for transfusion oversight of over 220,000 units of blood and blood products per year and the donation of over 27,000 blood and blood products per year through the University of Texas M.D. Anderson Cancer Center Donor Services. The services also assist with oversight of Quality Control/Quality Assurance programs related to transfusion medicine. The successful candidate must have adequate clinical skills to be able to interact and consult with a variety of oncology patients, consulting physicians, and transfusion medicine donors and the ability to assess and manage the clinical care transfusion requirements for acute oncological clinical presentations.
CLINICAL
• Participates in all Transfusion Medicine activities for patient care and donor services.
• Must be able to visually review, evaluate and correctly interpret medical records, patient data, patient specimens, blood and blood products, and test results based on previous training, experience and knowledge.
• Must be able to visually identify specimen constituents, contents and/or components directly or viewed through a microscope and integrate observations into diagnostic and biologically relevant information.
• Must assist in the continuing enhancement of new technologies for transfusion medicine services.
• Must be able to comprehend the relevance of printed results and correlate patient data with research and clinical findings.
• Must be able to ensure that quality control/quality assurance standards are implemented and that the laboratories which the candidate directs are in compliance with the numerous regulatory and accreditation requirements of transfusion medicine services.
• Must be able to relate quality control result data to specimen and product analysis data, assuring that appropriate action is taken based on results obtained.
• Must be able to identify and solve problems related to job responsibilities utilizing knowledge and experience.
• Must be able to work using standard precautions for bio-hazardous materials and exercise appropriate control and precautions in the management of other chemical and organic compounds as required for the regulatory compliance of a clinical laboratory.
• Must be acquainted with the manual and technical procedures and equipment used in donor services and transfusion medicine.
• Must have basic computer skills including word processing, spreadsheet, email, internet and databases.
• Must have manual dexterity for various functions with the instruments used in product collection and processing, laboratory diagnosis and research.
• Must be able to move from one laboratory to another.
ADMINISTRATVE
• Assures compliances with the standards of CMS/CLIA, CAP, JC, FDA, AABB, and other regulatory and accreditation agencies as required.
• Gives direction, guidance, prioritization, and technical assistance to laboratory personnel.
• Interviews applicants, evaluate laboratory personnel on their job performance, and makes hiring promotion, merit, and termination recommendations and decisions.
• Participates in and supports process improvement initiatives.
• Represents Transfusion Medicine on the UTMDACC Transfusion Medicine Committee and other relevant clinical staff and hospital committees.
• Represents Transfusion Medicine in local, regional, state and national meetings and organizations.
RESEARCH
• Demonstrates commitment to the clinical, translational, and investigational aspects of transfusion medicine including emerging technologies.
• Collaborates with diagnostic investigators and users at MDACC and other institutions.
• Demonstrates the ability to design, execute, interpret and integrate scientific data for publication in peer-reviewed journals and for research applications.
• Has developed and will maintain an independent laboratory research program (preferred, but not required).
• Seeks government and/or private agency funding support for his/her independent research (preferred, but not required).
EDUCATION
• Supports and participates in the training of fellows in the Transfusion Medicine Training fellowship program and in the rotations of fellows and residents from Laboratory Medicine and other Divisional fellowship programs.
• Must be able to present lectures and journal clubs to faculty, fellows and technical personnel using appropriate visual aids.
• Must have teaching skills to train a spectrum of personnel including other faculty, post-doctoral and pre-doctoral fellows, residents, medical students, technologists, School of Health Professions students, technicians, and other laboratory personnel.
PERSONAL CHARACTERISITICS
• Must be a self-motivated, energetic, committed and conscientious professional who communicates effectively, both verbally and in writing; has leadership skills and experience; is compliant with organizational regulatory requirements; and relates well to others who are in professional, technical or administrative roles in the Division.
• Has demonstrated the ability to work effectively in a matrix organization with complex interdisciplinary interactions and maintain interpersonal relationships and collaborations.
• Must maintain up-to-date general knowledge in the field of pathology and laboratory medicine and board certification.
• Must have the ability to interact and communicate effectively with clinicians, patients and donors The candidate's major responsibilities will be to assist in oversight of operations with particular emphasis on the scientific, technical, regulatory, and interpretative activities. The candidate will assist transfusion medicine and donor services with operational clinical activities and the daily operation of a very busy transfusion medicine service. Specific activities include compliance with CMS/CLIA, FDA, OSHA, AABB, CAP, JC and relevant state statutes and regulations. The successful candidate will be involved in an intensive and active clinical consultation service providing for transfusion oversight of over 220,000 units of blood and blood products per year and the donation of over 27,000 blood and blood products per year through the University of Texas M.D. Anderson Cancer Center Donor Services . The services also assist with oversight of Quality Control/Quality Assurance programs related to transfusion medicine. The successful candidate must have adequate clinical skills to be able to interact and consult with a variety of oncology patients, consulting physicians, and transfusion medicine donors and the ability to assess and manage the clinical care transfusion requirements for acute oncological clinical presentations. The candidate's major responsibilities will be to assist in oversight of operations with particular emphasis on the scientific, technical, regulatory, and interpretative activities. The candidate will assist transfusion medicine and donor services with operational clinical activities and the daily operation of a very busy transfusion medicine service. Specific activities include compliance with CMS/CLIA, FDA, OSHA, AABB, CAP, JC and relevant state statutes and regulations. The successful candidate will be involved in an intensive and active clinical consultation service providing for transfusion oversight of over 220,000 units of blood and blood products per year and the donation of over 27,000 blood and blood products per year through the University of Texas M.D. Anderson Cancer Center Donor Services . The services also assist with oversight of Quality Control/Quality Assurance programs related to transfusion medicine. The successful candidate must have adequate clinical skills to be able to interact and consult with a variety of oncology patients, consulting physicians, and transfusion medicine donors and the ability to assess and manage the clinical care transfusion requirements for acute oncological clinical presentations.
QUALIFICATIONS AND REQUIREMENTS
Degree(s): M.D. or M.D., Ph.D. in a field appropriate to faculty role.
Board Certification: Board certification in Anatomic Pathology/Clinical Pathology or Clinical Pathology is a requirement. Board specialty certification by The American Board of Pathology in Transfusion Medicine or Transfusion Medicine board eligible is also required, with achievement of Transfusion Medicine board certification within 3 years of employment if of board eligible status.
Licensure: License-eligible orlicensed to practice in Texas.
Experience: Assistant Professor applicants must have at least 1 year of full-time post-doctoral training in transfusion medicine. Associate Professor applicants must have at least 5 years' experience as Assistant Professor or equivalent or 10 years' experience post clinical degree. Two years' experience in supervising an academic transfusion medicine service is preferred. Related training in other immunological, immunogenetics, or histocompatibility testing is not required but would assist in the delivery of transfusion medicine clinical services.
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
  • Requisition ID: 176772
  • Employee Status: Regular
  • Minimum Salary: US Dollar (USD) 0
  • Midpoint Salary: US Dollar (USD) 0
  • Maximum Salary : US Dollar (USD) 0
  • FLSA: exempt and not eligible for overtime pay
  • Work Location: Onsite

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