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 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 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 development program.
• Product Knowledge: Understands the medical impact of vaccines.
• 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 differing opinions.
• 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 building.
• 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.
LICENSES/CERTIFICATIONS:
• ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
TRAVEL REQUIREMENTS:
• Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately 20 % travel.