AIT Bioscience
  • - QA
  • Indianapolis, IN, USA
  • Salary
  • Full Time

AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries.  LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioassay support of the development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.

AITB is the first and only CRO to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system.  With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it.  Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.

To support our continued growth, AITB is seeking a senior level quality professional for our Director of Quality Assurance position.

The Director of Quality Assurance is responsible for assuring that the most current regulatory expectations are incorporated into our Quality Management System (QMS), and that all staff are kept apprised of regulatory changes.  The successful candidate will have significant quality assurance work experience in pharma, biotech, or CRO.  This is a leadership role requiring collaboration with other members of the company's leadership team and operational management. This is a highly visible position as the director interfaces regularly with clients, regulators, professional associations, QA staff and colleagues across the company.

Essential Functions

  • Provide quality leadership and oversight for the QA team and the company; model the tone and vision of regulatory expectations;
  • Hire, train, and mentor quality assurance team staff, and manage external quality/regulatory consultants or vendors;
  • Develop and oversee quality systems that assure data quality and integrity, specifically with respect to electronic systems;
  • Identify industry quality trends and changes; provide assessment/impact on company's services and processes;
  • Implement changes to QMS based upon regulatory or industry changes;
  • Ensure that initial and annual regulatory training are completed by all company employees;
  • Develop and provide ongoing training and feedback to all company employees regarding quality/regulatory topics;
  • Host regulatory and client audits;
  • Ensure that all regulated studies are sufficiently audited and reported to management;
  • Ensure the vendor assessments are conducted for vendors providing services or products used in regulated study conduct;
  • Oversee the quality portions of computerized system validation and equipment qualification;
  • Review standard operating procedures for regulatory compliance prior to management approval and implementation;
  • Oversee the Corrective and Preventative Action (CAPA) system
  • Oversee physical and electronic archives;
  • Represent the company to clients, prospects, industry contacts, professional associations and in other business relationships as a member of the company's leadership team.

Minimum Requirements

  • Bachelor's degree or higher in a life sciences field.
  • Master's in Quality Assurance or Regulatory Affairs preferred.
  • Minimum 10 years of relevant quality assurance experience within an FDA GLP/GCP regulated industry. Prior CRO quality assurance experience preferred.
  • Minimum of 2 years prior management experience.
  • Strong understanding of business conduct in a CRO and regulatory compliance surrounding electronic systems.
  • Mastery of current U.S. FDA regulations, international regulations, and industry standards related to bioanalytical conduct including, but not limited to; 21 CFR Part 58, 21 CFR Part 11, OECD GLP Principles, 2018 FDA Bioanalytical Method Validation Guidance, 21 CFR Part 320 and EMA Guideline for Bioanalytical Method Validation.
  • Professional membership in a relevant Quality professional association; Quality certification a plus (RQAP, RAPS).
  • In depth knowledge of requirements for software application validation activities and equipment qualifications.
  • Prior leadership of and active involvement in regulatory inspections.
  • Excellent interpersonal, communication, project management, and presentation skills; ability to positively influence outcomes.
  • Analytically strong, with great attention to detail.
  • Demonstrated ability to lead a team, including remote team members.
  • Solutions oriented; capable of manage multiple priorities; ability to complete work by assigned deadlines with appropriate urgency and manage quality resources appropriately.
  • Cannot be debarred by U.S. FDA from employment in FDA regulated industries.
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