Sr. Manager, R&D GxP Documentation and Training
- Life Edit Therapeutics
- Durham, North Carolina
- Start date
- Mar 7, 2023
- Administration, Regulatory, Science/R&D, Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Bio NC
The Senior Manager of R&D Documentation and Training will be responsible for the archives at Life Edit Therapeutics, Inc. for paper-based and electronic documents and specimens related to R&D, GLP and/or GMP activities conducted by the company, which may be housed in the archive room at Life Edit, at GLP or GMP service providers or third party commercial research, GLP or GMP archive facilities. This individual will also coordinate training and facilitate establishing training role profiles, curricula and training items for Life Edit, working closely with EHS and Quality Systems at ElevateBio Basecamp, and serve as the go-to expert in navigating the Quality Management Systems for managing documentation and training. This position will contribute to ensuring alignment with corporate goals and timelines by facilitating training, integrity in research, documentation and compliance. Note that Life Edit does not conduct GLP activities in-house, but practices the “spirit of GLP” and does sponsor such studies and may act as a test site with a GLP exception in the study protocol. With regard to GMP activities, in addition to ElevateBio activities, Life Edit manages third party contract manufacturers for development and GMP manufacturing. Life Edit may also test clinical samples for research purposes, where HIPAA and informed consent in accordance with GCP must be adhered to.
Here’s What You’ll Do:
- Establish and maintain as needed internal archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports in a manner that minimizes deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens.
- Contract with commercial archives as needed to provide a repository for all material to be retained, working with Compliance at ElevateBio Basecamp to qualify external service providers.
- Index all materials maintained in internal and external archives to permit expedient retrieval and ensure that internal archives have specific reference to any external storage locations.
- Manage access to the archive room for only authorized personnel.
- Should a facility conducting nonclinical testing with Life Edit as the sponsor go out of business, notify the FDA of the transfer of all raw data documentation and other material stored at the facility to the archives of Life Edit.
- Maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study, and ensure their archival.
- Serve as the go-to expert in navigating electronic systems for training and documentation, ensuring applicable procedures, GMP, GLP and GCP requirements are followed.
- Coordinate updates / communications into the Management Review process regarding Life Edit documentation and training metrics, escalation items / issues and changes.
- Facilitate and drive the establishment of role profiles, training curricula and training items by working closely with managers and learners.
- Support the standardization of processes and communication(s) to build efficiencies within the ElevateBio ecosystem.
- Proactively seek out opportunities for organizational and operational improvement, influencing within Life Edit Technical Operations and ElevateBio Basecamp Quality Systems for change (e.g., compliance, team structure, processes, communication, etc.).
- Support internal and external audits with regard to acting as a subject-matter expert on Life Edit’s documentation and training approach and retrieving materials from archive.
- Bachelor’s Degree required. Degree in a Life Science, Chemistry or related discipline preferred.
- 5+ years of experience working in a biotech or pharmaceutical environment
- 2+ years of experience working with R&D, GLP and/or GMP documentation and/or training systems in biomedical industry. Cell/gene therapy preferred.
- Strong verbal and written communication skills with ability to build professional relationships with external and internal stakeholders a must
- Veeva experience or similar electronic management system is preferred; experience with electronic laboratory notebooks (Benchling) a plus
- Attention to detail and accuracy with respect to internal and external reporting
- Strong understanding of GLP and/or GMP regulations and guidelines related to documentation and training (US and EU preferred)
- Patience to steward and inform, rather than ‘police’, best practices for a regulatory ready research environment
We’re committed to finding the best ways to support our teams so they can do their best work. We take care of our employees, right from the start.
Health & Wellness
- Medical, vision, and dental insurance covered at 90%
- Low deductible, no co-insurance and no copays for mental health visits (for in-network care)
- Annual fitness reimbursement
- Employer paid for access to wellness apps and programs like Task Human
- Competitive compensation
- 401(k) retirement plans with a 4% employer match and no vesting period
- Employer-paid life insurance and short- and long-term disability insurance
- Employer-sponsored flexible spending accounts (FSA) and dependent care account (DCA)
- Access to a 1-on-1 financial advisor
- Commuter reimbursement benefit
- Monthly cell phone stipend
Time Off & Flexibility
- Unlimited paid time off, including vacation, sick leave, family leave, personal days, and bereavement
- 18 paid company holidays, plus an end-of-year holiday shut down
- 12 weeks of parental leave
- Federal Family and Medical Leave Act (FMLA) and Massachusetts Paid Family and Medical Leave (PFML), administered by Unum
- Insights Discovery training for every employee to make the most of workplace relationships
- Ongoing professional development, including manager training
- Access to LinkedIn Learning, a self-guided online education platform
Why join Life Edit Therapeutics?
Life Edit Therapeutics, an ElevateBio portfolio company, is a gene editing company on a mission to rewrite the future by curing disease, making any edit, anywhere. Life Edit has built a world-class genome editing platform with one of the world’s largest and most diverse collections of novel RNA-guided nucleases (RGNs) and base editors. The company’s next-generation editing systems will propel the development of novel human therapeutics by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies.
Our Vision: To pave the way to faster, safer, gene editing therapeutics that cure disease and improve patient lives
Life Edit is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Life Edit will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Life Edit Therapeutics, an ElevateBio company, is a next-generation genome editing company that has built a highly innovative platform with one of the world’s largest and most diverse collections of novel RNA-guided nucleases (RGNs) and base editors. The platform allows Life Edit to target any genomic sequence and develop novel human therapeutics for the most challenging genetic diseases by enabling ex vivo engineering for cell therapies and regenerative medicines and in vivo delivery of gene therapies. In addition to developing its own pipeline of cell and gene therapies, Life Edit Therapeutics will continue to strengthen its platform of genome-editing enzymes, provide gene-editing expertise to strategic partners, and form other third-party partnerships to discover and develop new therapies.
507 Airport Blvd. Suite 101
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