Courage to create something that matters
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We are ONE.
We, TOGETHER, are Sigilon.
Always Growing
We are change-makers, and we never stop in our quest to advance therapies for patients in need. For us that takes a number of forms — we stay abreast of the most recent Sigilon science at our Sigilon Monthly Sessions, where a team member presents their findings and cross-pollination of ideas is encouraged; we also meet up informally, around the weekly Friday breakfast or in our collaboration hubs outside the lab. In this way, we’re always inspiring one another and advancing science that matters.
Never Losing Sight of Our Purpose
We’re at Sigilon to make a difference for patients, and that is front and center in our day to day work. We host patients and caregivers at our offices to learn more about the disease areas we aim to treat. And we stay engaged with the broader community, from organizing a fundraiser to send young people to the New England Hemophilia Association Family Camp, to sponsoring rare disease awareness efforts.
Enjoying Our Relationships
From our Sigilon running team to occasional yoga outings to escape rooms and offsite retreats, we really enjoy our teamwork in all forms. We are a close-knit team with an upbeat atmosphere, and it shows in our productive science — a true team effort.
Life at Sigilon
Current openings
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Sigilon Therapeutics is seeking an individual with expertise in pharmaceutical/biotechnology quality assurance, excellent communication skills, and the ability to work in a highly interactive and matrixed environment. The incumbent will serve as integral member of the Quality Group, focusing on implementation, maintenance and oversight of QMS documentation, administration of the corporate training program, deviation and CAPA management, and internal auditing, This role will require daily interaction with stakeholders including but not limited to Chemistry, Biology, Clinical Operations, Contract Manufacturing Organizations (CMOs), Clinical Research Organizations (CROs), and External Testing Laboratories.
Presentation of written and oral summaries of progress in team meetings as well as to management is expected. Supporting Quality initiatives as well as leading and participating in Quality projects as required.
Responsibilities:
- Quality Management System (QMS) Documentation Oversight and Compliance
- Manage implementation, management, and maintenance for all QMS procedural documents for all operational departments and acquisitions including archive and electronic storage of original signature documents
- Initiate and drive to completion the review/revision of all QMS documents per plans and schedules
- Assume primary authorship or major contributor for specific procedural revisions as assigned
- Batch record and C of A review and release
- Administration of corporate training program (in collaboration with department heads) involves the following activities:
- In collaboration with department heads, monitor global compliance to Corporate Training Policy and implement needed corrective and preventive actions
- Maintain role-based definitions of training requirements, enroll staff in computer-based-training programs, track staff training compliance to completion
- Report and escalate training non-compliance to senior management as applicable
- Support audit requests for training records including review of training and ad hoc corrections to those requested records as necessary.
- Internal Audits
- Prepare, conduct, and produce reports for process audits of key Sigilon departments and workflows on a scheduled basis to confirm compliance with the established SOPs
- Such audits include but are not limited to Chemistry, Biology, Engineering, IT, Manufacturing. Ensure all findings are resolved effectively in a timely manner.
- External Audits
- Prepare, conduct, and produce reports for process audits of key Sigilon suppliers/vendors on a scheduled basis to confirm compliance to relevant global regulatory regulations,master and quality agreements
- Such audits include but are not limited to CROs, CMOs and External Testing Laboratories
- Ensure all findings are resolved effectively in a timely manner.
Requirements
- B.S./B.A. Degree in scientific discipline, with a minimum 3 years of previous experience in quality assurance and systems in an FDA regulated or similar environment preferred.
- Experience with electronic document management systems, quality management systems, and electronic learning management systems (LMS). Working knowledge of relevant industry and government regulations including: 21 CFR 11. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2). Uses industry knowledge to drive best-practices within company
- Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams
- Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2), etc)
- Experience in interacting with Health and Regulatory Authorities (e.g. inspections)
- Experience in deviation investigation and CAPA implementation
- Possess a strong attention to detail and have exceptional interpersonal, organizational and communication skills
- An energetic self-starter who is adept at multi-tasking, has a track record of productivity and capable of working both independently and as part of multiple collaborative teams
- Ability to prioritize responsibilities to meet project deadlines and flexibility to react quickly to changing research needs
- Travel up to 10%
Special considerations:
- Candidate must possess effective communication skills, and proven abilities in interfacing with colleagues in a number of different departments and managing multiple projects/priorities. Must be methodical, well organized and detail oriented. Individual must be highly self-motivated, readily adaptable to a fast-paced, multidisciplinary team-based environment and capable of working autonomously with little direct supervision.