Responsibilities:
- Manage the documentation control process for AAV gene therapy manufacturing, including reviewing, revising, and approving SOPs, work instructions, methods, and forms to ensure compliance with regulatory requirements and industry best practices.
- Perform detailed review and approval of laboratory records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations.
- Lead and support investigations of deviations and non-conformances related to laboratory events, conducting root cause analysis, and implementing CAPA measures to prevent recurrence.
- Conduct internal audits of laboratory activities to assess compliance with cGMP regulations and quality systems, identifying areas for improvement and recommending corrective actions.
- Assist in the preparation and execution of external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing.
- Provide training and guidance to laboratory personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
- Collaborate with cross-functional teams, including Quality Control, Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives.
- Maintain accurate and up-to-date documentation of all quality assurance activities related to AAV gene therapy manufacturing, ensuring compliance with record-keeping requirements.
- Stay abreast of evolving regulatory requirements, industry trends, and best practices related to AAV gene therapy manufacturing, and propose and implement necessary changes to maintain compliance.
- Support the implementation and maintenance of electronic quality management systems, ensuring effective document control and data integrity specific to AAV gene therapy manufacturing.
Qualifications:
- Bachelor’s Degree in a scientific or related field (or equivalent experience).
- Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry.
- Strong knowledge of cGMP regulations, quality control, quality systems, and quality assurance principles.
- Experience with document control processes and systems, including SOPs, work instructions, methods, and forms.
- Proficient in reviewing and approving laboratory records for Quality Control, ensuring compliance with cGMP regulations.
- Understanding of deviation management processes and root cause analysis.
Preferred:
- 7+ years of experience in a Quality role in the pharmaceutical or biotechnology industry
- Experience in a Quality Control laboratory.
- Experience working in biologics (ex. gene therapies).
Competencies:
- Excellent communication skills, both written and verbal, with the ability to effectively communicate complex quality-related concepts to cross-functional teams.
- Strong attention to detail and organizational skills, with the ability to manage multiple tasks and priorities in a fast-paced environment.
- Proficiency in using electronic quality management systems and document control software.
- Ability to work independently and collaboratively with cross-functional teams.
