Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design™ platform for CRISPR-based genetic medicine.
We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for a Director / Senior Director, Quality Operations to join our team and advance our platform. The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building Quality Operations and Compliance strategies for CRISPR-based therapeutics. Furthermore, the candidate would offer expertise in efficiently navigating the GXP complexities inherent to gene editing programs.
Key Responsibilities:
- We are seeking a dynamic team member to lead our growing quality functions
- The successful candidate will be responsible for building and leading a strong QMS, ensuring compliance with regulatory requirements, maintaining audit readiness and interfacing with CDMO/CRO quality and technical teams, and driving continuous improvement initiatives across all aspects of our operations
- Develop and implement quality management systems (QMS) in accordance with applicable regulations (e.g., FDA, EMA, ICH) and industry best practices
- Oversee all quality control and quality assurance activities throughout the product or project lifecycle, for early development to late clinical phase, 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
- Serve as an expert resource, internally, for GXP training activities
- Establish and maintain key performance indicators (KPIs) to track and improve quality metrics for management review, such as deviation and CAPA rates, environmental monitoring trending, audit performance, supplier quality, change control, etc to understand process improvements and product performance.
- 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, and proactively integrate regulatory intelligence into Quality systems / Control strategies is important.
- 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.
- Provide Quality review and impact/implementation assessment of proposed Change Control records and manage the associated regulatory notifications
Required Skills and Background:
- 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. Understanding of the drug development pathway with phase-appropriate requirements to develop a QMS & structure within the organization.
- 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.
Salary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you! Visit us at www.scribetx.com.
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.
At the time of posting, the base pay wage range for this role will vary depending on level. The offered pay range will depend on internal equity and the candidate’s relevant skills, experience, qualifications, training, and market data. Additional incentives are provided as part of the complete package in addition to comprehensive medical and other benefits.
