Director of Quality Operations

2 days ago

Fremont, California, United States Scribe Therapeutics Full time
Job Title: Director/Sr. Director, Quality Operations

Scribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of diseases. Our team of experts, including CRISPR inventors and leading molecular engineers, is dedicated to developing custom engineered enzymes and delivery modalities as part of our proprietary CRISPR by Design platform.

We are seeking a highly skilled and motivated individual to join our team as a Director/Sr. Director, Quality Operations. The successful candidate will have a strong background in quality assurance, quality control, and quality operations within the biotechnology industry. Experience with cell and gene therapy is a plus.

Key Responsibilities:
  • Develop and implement quality management systems (QMS) in accordance with global regulations, including FDA and EMA requirements.
  • Oversee all quality control and quality assurance activities throughout the product or project lifecycle, including supplier qualification and raw material testing, in-process monitoring, and final product release.
  • Collaborate with stakeholders on quality and compliance aspects of technology transfer and new product introduction.
  • Establish and maintain key performance indicators (KPIs) to track and improve quality metrics for management review.
  • Develop and maintain process(es) for product life cycle management from Research to Development and into Clinic.
  • Stay abreast of emerging regulations, guidance's, standards, and industry trends relevant to cell and gene therapy products.
  • Conduct internal audits and provide support towards interactions with Regulatory agencies, and partners, ensuring adherence to GXP.
  • Collaborate with cross-functional teams and CDMOs or CROs to address compliance issues, CAPAs, and quality system deficiencies in a timely and effective manner.
  • Champion a culture of compliance and quality excellence through training, coaching, and fostering a mindset of continuous improvement.
  • Lead risk assessment activities to identify and mitigate quality and regulatory risks associated with manufacturing processes, supply chain management, and product development.
  • Develop risk management plans and ensure proactive risk mitigation strategies are implemented to maintain product quality and regulatory compliance.
  • Recruit, mentor, and develop a high-performing team of quality professionals, fostering a culture of accountability, collaboration, and professional growth.
  • Provide strategic direction and leadership to the quality team, empowering them to achieve departmental goals and objectives.
  • Assist to develop and support an operating budget.
  • Collaborate cross functionally with nonclinical, CMC, and quality leadership and stakeholders on collaborating and coordinating regulatory submissions.
Requirements:
  • Minimum 10 years experience in quality assurance, quality control, and/or quality operations within the biotechnology industry. Experience with cell and gene therapy will be a preference but not mandatory.
  • In-depth knowledge of global regulations governing cell and gene therapy products, including FDA and EMA requirements.
  • Strategic thinker with a demonstrated ability to develop and implement quality and regulatory strategies aligned with business objectives.
  • Ability to have keen attention to detail and get Quality Operations clearly laid out into systems processes and procedures.
  • Writing SOPs, Reviewing Protocols and Reports is important. Creating and maintaining Training records is necessary. Maintaining a document control system with all Quality attributes is important.
  • Experience with QMS and ability to onboard, implement and maintain a validated QMS is required.
  • Exceptional communication skills to mentor, guide and train in compliance related matters is a plus.
  • Experience with regulatory inspections and/or CDMO/CRO audits and internal audits is a plus.
  • Strong collaboration skills with a congenial attitude is strongly preferred.
  • Experience managing complex schedules and shifting priorities in a dynamic environment is a plus.
  • Finding ways to create structure and maintain timelines in a dynamic start up environment will be a very important trait.

We offer a competitive salary and comprehensive benefits package. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.

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