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Director of Quality Assurance
Director of Quality AssuranceVitaCyte LLC • Indianapolis, IN, US
Director of Quality Assurance

Director of Quality Assurance

VitaCyte LLC • Indianapolis, IN, US
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [job_card.permanent]
[job_card.job_description]

Job Description

Job Description

VitaCyte is a leading manufacturer of purified-defined bacterial collagenase and associated protease enzymes for enzyme-mediated cell isolation and other biotherapeutic applications. The company received ISO 9001 : 2015 certification in 2025 and has established a Quality Management System (QMS) compliant with ISO 9001 and industry standards and regulations.

  • Job Purpose

Maintain the QMS to ensure compliance with ISO 9001 and applicable regulatory standards in a state of inspection readiness.

  • Duties & Responsibilities

    • Ensures VitaCyte personnel comply with an ISO 9001 certified QMS and applicable regulatory requirements.

  • Draft, revise, and maintain all controlled policies and procedures comprising the QMS
  • Rigorously review all manufacturing batch records and quality control results to ensure completeness and compliance with quality standards and established specifications
  • Review corrective and preventative root cause investigations; evaluate effectiveness
  • Establish maintenance, calibration, qualification, and cleaning requirements for equipment and instruments to ensure compliance with ISO and cGMP requirements
  • Prepare and approve all validation and qualification plans
  • Facilitate internal audits and correct instances of non-conformance
  • Review and maintain current training records for each individual and role
  • Approve the qualification of all suppliers
  • Qualifications

    • Education / Experience

    BA / BS, MS, PhD. degree in a relevant field (Biological science, chemistry, engineering, business operations)

  • Minimum 3-years experience working with a quality management system
  • Minimum 5 years direct experience in manufacturing biological products
  • Knowledge of applicable standards and regulations (ex. ISO 9001, ICH Q7, 21 CFR Part 210 / 211)
  • Maintaining ISO certification is preferred.
  • Experience with eQMS and / or CMMS software preferred.
  • Auditing experience preferred.
  • Skills / Abilities

    • Proven expertise in concepts and methodologies of QA

  • Detail-oriented, organized and attentive to analyzing processes with the ability to identify trends, problems, or opportunities for potential improvements
  • Extensive experience in QMS or regulatory compliance
  • Strong interpersonal skills with a desire and ability to work in interdisciplinary teams
  • Proficiency with Microsoft Excel, Word, and Outlook
  • Benefits

    • Full-time, permanent position including a comprehensive family medical benefit package and participation in an employer-matched 401K plan.

  • Salary is commensurate with experience.
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