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9 days old

Associate Director, Clinical QA Remote

Kelly Services
Indianapolis, IN 46202 Work Remotely
Associate Director, Clinical QA Remote


**Overview:**


Provide quality and compliance oversight for all clinical development activities and will perform a wide variety of activities ensuring GCP compliance in accordance with applicable regulatory requirements.


Have an in-depth understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.


Direct and manage the internal and external GCP audit program to assure adherence to relevant FDA, EMA, ICH and other global regulations, guidelines, and procedures.


Support vendor oversight, document management, auditing (internal and external), inspection management and Quality Agreements in a clinical setting.


Provide QA oversight and strategic planning, coordination and continuous improvement of methods and processes to ensure the quality and integrity of clinical studies, and adherence to industry guidelines, Good Clinical Practice (GCP) and agency regulations.


Oversee the timely generation, review, and approval of documentation within the GCP QMS.


**Key Accountabilities:**


+ Provide quality oversight and support for all clinical development activities and act as a central contact for designated project communications, CAPAs, deviations, correspondences and associated essential documentation as appropriate.

+ Management of clinical quality issues, investigations, and inspections.

+ Management and continuous improvement of the GCP vendor quality management program and processes. Conduct audits, as needed, which will include internal, clinical investigator sites, clinical vendors, TMFs and other vendor audits to assess quality level and compliance with applicable GCP regulations and industry standards.

+ Continuous evaluation over the course of a contract to ensure that a vendor meets the regulatory compliance and operational standards.

+ Support Clinical during study start up and review of study plans for quality oversight.

+ Schedule and track audits in accordance with approved audit plans.

+ Assist in clinical trial site and vendor audit selection processes.

+ Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards.


+ Proactively identifies, analyzes, and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.

+ Create and maintain audit findings and CAPA database/tracking and analysis.

+ Compile quality metrics related to clinical quality oversight, audits, and management of vendors for dissemination at meetings, as appropriate.

+ Assist in the authorship and/or review of company policies, procedures, SOPs, and work instruction documents as they relate to GCP.

+ Schedule and manage GCP training requirements for internal personnel.

+ Maintain required knowledge and compliance of applicable regulations and government, industry, and company GCP standards and their interpretations.


**Requirements:**


+ BS/BA degree in a scientific discipline required; Advanced degree preferred.

+ Minimum 10 years of experience in the pharmaceutical, biotechnology or related health care industry.

+ Minimum 7 years of GCP-related Quality Assurance and relevant clinical trial experience, with increasing responsibility.

+ Anticipate some travel may be required within North America, and will need to be able to meet current travel requirements and guidelines.

+ Location of work Remote (Eastern Time Zone), with the anticipation of travel for team and client meetings.

**Competencies:**


+ Extensive knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development

+ 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.

+ Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.

+ Effective technical writing skills; able to write quality positions, audit reports, and procedures.

+ Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines with an appropriate sense of urgency.

+ Superior attention to detail and ability to analyze complex data.


**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-11-19 Expires: 2021-12-20

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Associate Director, Clinical QA Remote

Kelly Services
Indianapolis, IN 46202

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