Director of GCP Quality Assurance

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Job description

**Kelly is actively recruiting for a Direct Hire - Director of GCP Quality Assurance in Manhattan, NY.**

The Director, GCP Quality Assurance is responsible for defining, organizing, and implementing Quality Assurance activities related to Client's 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 Client's 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:

+ Clinical Science Team

+ Clinical Operations Team

+ Quality Assurance Team

+ Regulatory Affairs Team

+ Translational Team

+ External vendors e.g. CROs

+ Auditors

**POSITION RESPONSIBILITIES**

The key responsibilities include but are not limited to:

+ Drive continuous development and ensure maintenance of systems at Client's in compliance with cGCP guidelines; including drafting and approving Clinical and Translational SOPs.

+ Prepare audit plans and audit/risk mitigation plans

+ 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.

+ Clearly communicate and report (verbally and in writing) audit outcomes to the rest of organization and escalate quality issues as required.

+ Provide QA expertise to the organization and quality oversight of the clinical trials, drug safety and translational activities.

+ Evaluate contract partners (e.g., CROs) for the quality aspects, set up and review of procedures with external vendors.

+ Ensure QA oversight of clinical trial protocols, ICFs, CSRs and other clinical trial specific documents as requested.

+ Perform CSR audits.

+ Develop and maintain appropriate TMF management process.

+ Perform eTMF audits.

+ Manage and/or deliver yearly cGCP training for staff.

+ 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.

+ Maintain expert knowledge in regulatory requirements including cGCP principles

+ Ability to travel (mainly in the EU and USA).

**EDUCATION AND EXPERIENCE**

+ Master's Degree in Life Sciences; Pharmacist, Biology, Biochemistry, or related field

+ 8 years of relevant QA experience within the pharmaceutical industry, which includes clinical trials conduct and practical experience in regulatory inspection preparation and conduct.

+ Experience as an Auditor within the GCP area preferred.

+ Expertise in translational activity preferred.

+ Experience in Oncology is preferred.

+ Experience in Cell and Gene Therapy is a plus.

**Technical Skills Requirements / Core Competencies**

+ Able to translates relevant business strategies into functional area strategies.

+ Works on abstract issues requiring an in-depth knowledge of the company to analyze situations or data.

+ Able to participate in the development of methods, techniques and evaluation criteria for projects, programs, and people within Client's.

+ Ability to engage with internal/external stakeholders independently.

+ Exercise sound judgement in planning and/or making informed decisions.

+ Knowledge of pharmaceutical and/or biotechnology principles.

+ Strong understanding of Quality processes with flair for the practical angle to creatively reach a compliant solution.

+ 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 build, and maintain, effective working relationships throughout the GCP area at Clients. Including within a cross-functional, matrixed environment with Quality, Clinical Science, Clinical Operations, Regulatory Affairs, and Translational stakeholders.

+ Results and goal achievement-oriented and committed to contributing to the overall success of Clients Clinical/Medical and Translational Operations.

+ Ability to prioritize and multitask effectively to meet deliverables.

+ Maintain a positive attitude and thrive in a fast paced and changing environment.

+ Collaborative and strategic minded.

+ Customer / stakeholder focused and able to deal with ambiguity.

+ Exceptional verbal and written communication skills.

+ Proficiency in Word, Excel, and PowerPoint.

**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**

**_\#TJP2021_SPEC_**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **®** **?**

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()