Director, Gcp Quality Assurance

The Director, GCP Quality Assurance is responsible for defining, organizing, and implementing Quality Assurance activities related to Cellectis’ cGCP activities. This role is responsible for the QA oversight of all cGCP related tasks. Director, GCP Quality Assurance is responsible for anticipating and preparing for Cellectis’ growth in Quality cGCP activities, including supervising multiple external vendors, in multiple location (EU/US), ensuring consistency and compliance to current regulatory guidelines and compliance with regulatory filings.

The Director, GCP Quality Assurance is also a crucial link between various stakeholders including:

• External vendors e.g. CROs
• Clinical Operations Team
• Quality Assurance Team
• Auditors
• Clinical Science Team
• Translational Team
• Regulatory Affairs Team

POSITION RESPONSIBILITIES
The key responsibilities include but are not limited to:

• Maintain expert knowledge in regulatory requirements including cGCP principles
• Perform CSR audits.
• Develop and maintain appropriate TMF management process.
• Evaluate contract partners (e.g., CROs) for the quality aspects, set up and review of procedures with external vendors.
• Prepare audit plans and audit/risk mitigation plans
• Drive continuous development and ensure maintenance of systems at Cellectis in compliance with cGCP guidelines; including drafting and approving Clinical and Translational SOPs.
• Provide QA expertise to the organization and quality oversight of the clinical trials, drug safety and translational activities.
• Manage and/or deliver yearly cGCP training for staff.
• Perform audits on clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to internal procedures as well as regulatory guidelines.
• Perform eTMF audits.
• Clearly communicate and report (verbally and in writing) audit outcomes to the rest of organization and escalate quality issues as required.
• Ensure QA oversight of clinical trial protocols, ICFs, CSRs and other clinical trial specific documents as requested.
• Provide advice internally and externally on cGCP and quality matters.
• Proactively lead, or coordinate across, the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections.
• Ability to travel (mainly in the EU and USA).

EDUCATION AND EXPERIENCE

• Expertise in translational activity preferred.
• Master’s Degree in Life Sciences; Pharmacist, Biology, Biochemistry, or related field
• Experience in Cell and Gene Therapy is a plus.
• Experience as an Auditor within the GCP area preferred.
• Experience in Oncology is preferred.
• 8 years of relevant QA experience within the pharmaceutical industry, which includes clinical trials conduct and practical experience in regulatory inspection preparation and conduct.

Technical Skills Requirements / Core Competencies

• Ability to build, and maintain, effective working relationships throughout the GCP area at Cellectis. Including within a cross-functional, matrixed environment with Quality, Clinical Science, Clinical Operations, Regulatory Affairs, and Translational stakeholders.
• Exercise sound judgement in planning and/or making informed decisions.
• Knowledge of pharmaceutical and/or biotechnology principles.
• Collaborative and strategic minded.
• Works on abstract issues requiring an in-depth knowledge of the company to analyze situations or data.
• Maintain a positive attitude and thrive in a fast paced and changing environment.
• Results and goal achievement-oriented and committed to contributing to the overall success of Cellectis Clinical/Medical and Translational Operations.
• Strong understanding of Quality processes with flair for the practical angle to creatively reach a compliant solution.
• Able to translates relevant business strategies into functional area strategies.
• Exceptional verbal and written communication skills.
• Customer / stakeholder focused and able to deal with ambiguity.
• Ability to engage with internal/external stakeholders independently.
• Able to participate in the development of methods, techniques and evaluation criteria for projects, programs, and people within Cellectis.
• Proficiency in Word, Excel, and PowerPoint.
• Ability to identify and effectively communicate QA associated Risks.
• Be able to work independently, and as a part of an internal or cross functional team, within a collaborative setting.
• Ability to prioritize and multitask effectively to meet deliverables.

PHYSICAL POSITION REQUIREMENTS

Requires the ability to sit or stand at a computer for long stretches of time and type. Frequently operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. The person in this position needs to occasionally move about inside. the office to access. file cabinets and office equipment.