Director, GCP Quality Assurance
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. The Director, GCP Quality Assurance role at Sana will provide expertise and guidance on Good Clinical Practice (GCP) applicable regulations to development teams to proactively identify compliance issues/risks and recommend mitigations. This role will independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners and internal systems in compliance with GCP. The Director, GCP Quality Assurance will coordinate GCP compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, IT, and Pharmacovigilance to support Sana clinical studies.
This role and will be directly involved in development and continuous improvement of GCP Quality, Implementation of electronic quality management system, risk-based vendor and site audits, and overall Quality Management Systems as Sana grows.
What you’ll do
- Contribute to the development, implementation, and maintenance of GCP quality systems and SOPs
- Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study
- In partnership with Clinical Operations and other impacted functional areas contribute to the design and implementation of a risk-based clinical Quality Assurance management system. Develop and execute strategic plans to identify, mitigate, monitor, and report site, study and program level compliance risks
- Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
- Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management
- Develop and implement risk-based GCP audits and compliance strategies. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
- Set up and manage the clinical investigator site audit program. Set up a risk-based approach to clinical site audits and work with the clinical team to detail risk-based criteria. Ensure the site audits are appropriately scoped, planned executed and closed
- Coordinate with functional area leads and vendors on Inspection Preparation activities including mock inspections, gap assessment, story boarding, and resolution and mitigation of identified compliance concerns
What we’re looking for
- Bachelor’s degree in the Life Sciences with 10+ years in pharmaceutical or biotech drug development. Advanced degree preferred
- Minimum 7 years of experience in Clinical QA, including both external and internal auditing (regulatory inspection experience is preferred)
- Solid knowledge of global regulatory requirements/standards (experience in cell and/or gene therapies, a plus)
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements
- Direct experience in development and oversight of Quality Management Systems
- Excellent interpersonal effectiveness and written/verbal listening/communication skills
- Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting
- Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels
- Excellent computer skills (quality and document management systems, clinical study-related systems (e.g., electronic data capture, interactive response technology, clinical trial management, etc.), and Microsoft products and services (e.g., Excel, PowerPoint, Visio, Word, etc.)
What will separate you from the crowd
- Previous experience facilitating and/or supporting Regulatory Authority Inspections
- GLP or GMP experience is a plus
What you should know
- This is a remote position with potential travel to Sana and audit sites
- Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
- The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together
- Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’s Benefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.