Associate Director/Director, Quality Systems and Documentation

Found in: Jooble US O C2 - 2 weeks ago

Boston MA, United States Scorpion Therapeutics, Inc. Full time

Scorpion Therapeutics is seeking a highly motivated and experienced Associate Director/Director, Quality Systems and Documentation to join our Quality team. The Associate Director/Director is responsible for providing leadership and strategic direction in the development, implementation, and maintenance of quality systems and documentation, as well as other process improvement initiatives, in compliance with GxP regulations. A successful candidate will possess a strong background in regulatory compliance, expertise in quality management systems and document control processes, attention to detail, and the ability to collaborate cross-functionally and communicate effectively. This position will report to the Head of Quality.

Key Responsibilities:

  • Provide leadership and daily management of the quality systems, training, and document control function, ensuring alignment with company goals and objectives.
  • Support GxP functions by developing and implementing policies, procedures, and processes to ensure compliance with regulatory requirements.
  • Provide training and guidance to staff, promoting a culture of quality and compliance throughout the organization.
  • Responsible for QA oversight for the selection, implementation, and lifecycle management of GxP computerized systems, including but not limited to electronic Quality Management systems for documents, training, and quality events.
  • Collaborate with cross-functional teams to ensure the successful quality initiatives and integration of quality systems, training, and documentation into all aspects of the organization.
  • Conduct risk assessments and gap analyses to identify areas for improvement in quality systems and documentation practices.
  • Monitor the performance of the quality management system through the use of key performance indicators (KPIs), metrics, effectiveness checks, and management review to identify trends and areas for improvement.
  • Responsible for the management of internal and external audits.
  • Provide support during Alliance Partner audits and regulatory authority inspections.

Professional Experience/Qualifications:

  • Bachelor’s degree in scientific or technical discipline, with a minimum of 8+ years of QA experience related to quality systems, training, and document control within the biotech/pharmaceutical industry.
  • Demonstrated experience implementing and validating GxP computerized systems, including broad and deep knowledge of regulations, guidance, good practices on electronic record, electronic signatures, and data integrity (e.g. 21 CFR Part 11, EU Annex 11, GAMP5, etc.).
  • Demonstrated experience in selecting, implementing, and managing electronic Quality Management Systems.
  • Knowledge of GxP regulations, with prior experience supporting GMP operations (e.g. reviewing batch records, managing quality events).
  • Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization.
  • Strong analytical and problem-solving skills, with the ability to identify and address complex issues in a timely manner.
  • Ability to thrive in a fast-paced and dynamic environment, with a commitment to continuous improvement and innovation.
  • Ability to be agile and wear multiple hats.
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