Quality Assurance Lead Auditor (Gcp)

Your keen eye for detail combined with extensive knowledge of GCP and clinical research guidelines are the stamp of approval to ensure that our clinical teams are staying on track at the highest level of excellence KCR prides itself on. Your ability to mentor, and to work interdepartmentally; communicating clearly, efficiently, and effectively using technology to complete audits in a business professional manner make you instrumental to keeping our clinical trials on point and moving the needle forward. If this is you, and you're looking for an opportunity that allows you direct access to leadership, and the opportunity to grow please review the position requirements below and apply. We invite you to use your natural inquisitive mind to learn more about KCR at the link below and look forward to hearing from you.
KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.
We see human behind every number™
Quality Assurance Lead Auditor
Location: US - Remote-based
Boston, MA or Raleigh/Durham, NC preferred
Quality Assurance Lead Auditor is required to perform quality and auditing activities in order to assess compliance with corporate requirements, industry standards and applicable regulations. Additionally, tasks may include, but are not limited to quality support to KCR clients/projects/teams, compilation and/or analysis of quality metrics, support of Quality Assurance e-system(s) including, but not limited to VeevaQMS, participation in client and regulatory inspections, review of KCR corporate procedural documents and general assignments directed by Quality Assurance Department Line Manager.
Quality Assurance Lead Auditor demonstrates comprehensive expertise in auditing areas with ability to conduct independent audits in these areas. Examples of standard auditing areas are: Internal Process Audits, Vendor Qualification Audits, Investigator Site Audits, Trial Master File Audits, Computer System Validation Audits
Your responsibilities:

• Plans, prepares, conducts, reports and leads follow-up activities for audits as lead and/or supporting auditor
• Provides support during sponsor and regulatory inspections, as needed and/or required
• Participates in KCR procedural document review lifecycle
• Supports KCR project teams through provision of regulatory guidance and quality support
• Executes tasks as required per SOP, including but not limited, to CAPA processing and oversight,
  corporate deviation processing and oversight, client complaints, corporate risks, ISO alignment
• Develops, extracts, and/or analyzes Quality metrics
• Ad hoc trainings within KCR, as needed
• Act as Project and/or Account Quality Lead
• Facilitates ad hoc trainings within KCR, as needed
• Supports development and maintenance of Veeva QMS
• Mentors junior staff members, as needed
• Conducts additional administrative and operational Quality tasks, as assigned by Department Line Manager

Education / Qualifications / Skills Requirements:

• Bachelor's degree from an accredited U.S. College or University
• Master's degree preferred.
• Minimum of 1 year auditing experience in relevant clinical research experience - contract research organization internal
• Minimum of 6 years of clinical research Quality Assurance function; with minimum of 5 years in an auditing role.
• Knowledge of GCP regulations. (GMP and GLP beneficial but GCP required)
• Working knowledge of local policies, procedures and guidelines, FDA and local regulations
  which are applicable to the clinical research space- GCP and fundamental knowledge of CSV is required; GMP and GLP knowledge is preferred however not required.
• Knowledge of ICH guidelines and clinical research process
• Basic statistical knowledge
• Fluency in English
• Excellent written and oral communication skills
• Sound judgement to evaluate discrepancies, make decisions and report findings
• Ability to produce quality reports and written communication
• Proficiency with computing software and knowledge about computer systems validation process (Previous Veeva experience preferred)
• Confidence and enthusiasm
• Flexibility and willingness to work in a team environment with an ability to manage work schedule independently, prioritizing tasks to benefit the organization.
• Availability for business travelling, including international travel if needed. (Up to 30%)

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER™ into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To demonstrate how appreciated your talent and your commitment are, KCR is offering you:

• 1 additional day off for your birthday
• Loyalty Bonus Program (anniversary award or additional anniversary paid time off)
• Referral program
• Additional PTO days during end of year holiday period
• Onboarding process and induction training to develop deep sector knowledge and complex skills
• Latest technology and the most advanced equipment and working tools
• An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement
• Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.

***This position is not open to agency solicitation***
Equal Opportunity Employer
KCR CRO Inc., provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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