Director of Clinical Quality

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.

Overview:

Candidates may need to travel to investigator sites
Candidates can sit remote but need to be able to travel to Cambridge
Local candidates preferred but they can work from home occasionally
1 year assignment to start. Not a perm assignment. Interim position.
Person must be able to coordinate other QA contractors for audits

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 with in 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 Description:

Job Title:
Director, Vaccines Clinical Compound Support Quality Assurance

OBJECTIVES:

• 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 implemented.

• 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.



ACCOUNTABILITIES :

• 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 regulations.

• 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 integrity.

• 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…