Website eTeam Inc.
eTeam Inc.
Company : eTeam Inc.
Job Title: Quality Assurance Manager
Location: Framingham, MA
Duration: 8 Months
" Hybrid role 3 days onsite " Open to candidates willing to relocate at their own expense " Free parking onsite No extreme and heat and cold; No heavy lifting or exposure to chemicals Day to day: Walk throughs, document review, deviations managements, meetings, interfacing with internal customers. Must have skills/ Required: " B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field or MS/ PHD with 2 years of related experience in Quality role. " GMP, pharma/ biotech exp required " Capa s, deviations " MS Office Suite " Veeva, SAP " Team player, attention to detail " Self-starter Nice to Have: " Experience with Gene Therapy/ ATMP processes (preferred) " Experience with aseptic processing (preferred)/ understanding
Our Team:
The R&D Global Quality Organization Genomic Medicine Unit (GQO GMU) team is responsible for external partner management, providing quality oversight of client-sponsored GMP manufacturing and testing of genomic medicines at third parties. This position will join a collaborative team dedicated to ensuring phase-appropriate manufacturing excellence while maintaining strong partnerships with Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs).
Main responsibilities:
" Support timely review of GMP documentation and ensure alignment with quality and regulatory expectations prior to release and/or approval (batch records, analytical data/specifications, validation protocols/reports, deviations, change controls, CAPAs, etc.).
" Maintain organization of project deliverables for external partner project using applicable tools.
" Identify, communicate, and mitigate quality risks in a pro-active and collaborative manner maintaining the business interests of client and consideration of suitable outcome for the projects.
" Participate in and support, or lead where appropriate, batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.
" Develop trusting internal team partnerships to ensure highly collaborative project outcomes.
" Develop trusting partnerships with external partners to ensure they understand, respect, and implement client s guidance on all Quality matters.
" Contribute to and review in the development of Quality Technical Agreements.
" Act as Quality Focal Point to represent site on CClient Quality sub-team(s) for assigned project(s).
" Promote Quality excellence and Quality Culture as a Quality Culture Liaison.
" Lead and/or support the drive for consistency and continuous improvement.
" Make decisions that uphold ethical standards.
" Support site project implementations, as assigned.
Experience:
" Experience in the pharmaceutical industry with a quality focus, including external partner/ CMO management
" Knowledge of Quality Systems and Quality Management programs
" Understanding of cGMP/ICH/FDA/EMA regulations, with background in regulations and guidance for drug substance/ drug product manufacturing and/or gene therapies
" Familiarity with Chemistry Manufacturing Controls (CClient) requirements
" Experience managing quality operations for manufacturing projects
Soft skills:
" Outstanding interpersonal and communication skills, including presentation abilities
" Being a demonstrated team player with experience contributing to multi-disciplinary project teams
" Working effectively with minimal supervision while maintaining strong collaborative relationships
" Strong project management skills and ability to work well under pressure
" Being highly organized with excellent attention to detail
" Managing multiple priorities while maintaining high productivity
" Having the ability to influence across internal and external networks, including Development, Manufacturing, Engineering, Digital, Quality, Regulatory Affairs, and external partners
Technical skills:
" Research & Development activities and processes (specifically in a CClient related field)
" Experience with Gene Therapy/ ATMP processes (preferred)
" Experience with aseptic processing (preferred)
" Proficiency with quality management systems and documentation tools
" Experience with external partner audits and quality assessments
" Knowledge of Quality Technical Agreements
Education:
" B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field
Languages:
" English: Fluent professional practice