Integrated Resources, Inc is a premier staffing firm recognized
as one of the tri-states most well-respected professional specialty
firms. IRI has built its reputation on excellent service and
integrity since its inception in 1996. Our mission centers on
delivering only the best quality talent, the first time and every
time. We provide quality resources in four specialty areas:
Information Technology (IT), Clinical Research, Rehabilitation
Therapy and Nursing.
Job Description Overview:
Candidates may need to travel to investigator sites
Candidates can sit remote but need to be able to travel to
Local candidates preferred but they can work from home
1 year assignment to start. Not a perm assignment. Interim
Person must be able to coordinate other QA contractors for
Must also be able to deliver SOP’s and processes and
This is ONLY in the GCP area
Must have GCP experience
Must have Pharma Experience within Quality Assurance
Coordinating audits (internal, external)
Inspection experience (FDA)
Need to have worked in a development program so they know how to
coordinate audits for a development program
Job Title: Director, Vaccines Clinical Compound Support Quality
• Plays a leadership role in ensuring that investigator, vendor,
facility and system audits are conducted, for communicating any
critical compliance risks noted from these activities to senior
management, and ensuring that corrective actions are
• Serves as a senior strategic GCP/PV quality resource to VBU
for its vaccine development activities, and takes a lead role for
the preparation, conduct, and responses to FDA audits of VBU's
Clinical Research effort.
• This position provides leadership and strategy in line with
global strategic objectives. Collaborates with all VBD functional
areas to ensure all assigned global clinical trial activities
sponsored by VBU are in compliance with Good Clinical Practice
(GCP) regulations, the International Conference on Harmonization
(ICH) and Policies and Procedures.
• Ensures the development and implementation of strategies
regarding the processes, procedures and quality standards required
to maintain compliance to applicable regulations.
• Responsible to develop and implement a strategic audit plan
for a VBU vaccines development program.
• Analyze audit program results, quality issues and
investigations in order to optimize regional operations and overall
regional state of compliance.Ensure that activities are conducted
and reports written according to applicable SOPs and
• Represents VBU and serves as Inspection Administrator during
regulatory inspections. Provides strategic organizational direction
to assure that responses are timely and appropriate to maintain
VBU's (US) good standing with regulatory agencies.
• Oversees all GCP QA, PVQA, and GCLP QA activities (including
internal or external audit observations and development of adverse
trends) in US and LATAM in order to ensure patient safety and data
• Identifies and mitigates GCP/PV/GCLP quality and compliance
issues with potential impact across multiple compounds, sites, or
functional groups within or outside of VBU .
• Collaborates with the R&D QA, and other global entities to
provide a consistent quality approach, including:
o Develops and presents periodic reports for assigned project
describing VBU compliance trends and identifying areas of potential
risk to VBU senior management.
• Determines acceptability of vendors for potential use by VBD
and provides direction, guidance and strategy for VBU Quality.
EXPERIENCE, KNOWLEDGE AND SKILLS:
Knowledge and Skills:
In-depth knowledge of the applicable GXP regulations, FDA Good
Clinical Practices, ICH Guidelines, FDA Regulations and Guidances
and Computer System Validation
• Auditing Knowledge: Demonstrates advanced knowledge in the
conduct and reporting of audits and the translation of findings
into corrective actions plans that mitigate risks to the company,
to safety and data integrity.
• Clinical Development: Understands the phases, processes and
techniques used to execute a clinical development program.
• Product Knowledge: Understands the medical impact of
• Science Knowledge: Possess the necessary science education and
knowledge to manage related clinical trials and to assure ethical
treatment of subjects. Understands medical terminology and is
familiar with standards of care and disease states.
• Communication skills: Must professionally, clearly, concisely
and consistently communicate to external and internal customers via
phone, e-mail, fax, and written documents. Must also be able to
demonstrate professional presentation skills deliver fair balanced
presentations and, when applicable, facilitate resolution of
• Negotiation Skills: Demonstrates proficiency in negotiation
and conflict resolution.
• Project Management: Must demonstrate proficiency in managing
complex projects, delivering all expected deliverables in a timely
manner, and proactively communicating changes in pre-established
goals and deadlines.
• Organizational skills: Must be able to prioritize work
effectively to meet timelines.
• Interpersonal: Must be able to adapt to other personalities in
a respectful manner that is conducive to goal achievement and team
• Computer skills: Must be able to efficiently utilize the
computer hardware and software programs provided to plan, manage,
conduct and track deliverables and to communicate with internal and
external team members.
• ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of
Quality/Organizational Excellence, or SQA Registered Quality
Assurance Professional preferred.
• Ability to drive to or fly to various meetings or client
sites, including overnight trips. Some international travel may be
• Requires approximately 20 % travel.
• B.S. in Biology, Nursing, Pharmacy, or related scientific
field. MS preferred.
• Minimum of 10 years of increasing responsibility in
pharmaceutical, GCP-related Quality environment.
• Minimum 7 years indirect management level experience in GCP
Quality Assurance including senior level project planning/budget
Additional Information Kind Regards,
Integrated Resources, Inc.
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th
Year in a Row)