Contract - Quality Assurance Specialist

Title:                   Contract - Quality Assurance Specialist

Location:           Cambridge, MA

Reports to:        Supervisor, Quality Assurance

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include a potential first-in-class oral therapy: VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

The QA Specialist is responsible for QA operations and QA documents/training. Additionally, the QA Specialist will support internal and external audits

Here’s What You’ll Do:

Ensure Vedanta facilities, utilities, manufacturing, and testing procedures and processes are compliant with GMP and phase-appropriate to support production and distribution by:

• Supporting QA Operations in manufacturing activities including but not limited to on floor support, executed document review, disposition and release (internal and external CMO), walkthroughs, etc.
• QA Document/Training in document control activities including document upload to QMS system and archiving of records for both document and training.
• Owning the revision of records and SOPS to align with GMP requirements as assigned.
• Collaborating with organization on the training of, and guidance/support of QMS system records such as Deviations, CAPAs, and Change Controls. Additionally owning QMS System records as required.
• Leading, supporting, and/or implementing improvement initiatives for QA and other organizations.

Department functions:

• Department Processes: Continues to improve or develop Quality Assurance department processes/guidance for internal interactions or between Vedanta and external stakeholders. Maintain documentation in accessible format, ensure new documents are created and stakeholders notified/trained as assigned.
• General Support: Provide guidance and mentoring on best compliance and industry practices within and across departments. Provide advice to others upon request.

Requirements:

• BS in Life Sciences with minimum 3 years in a pharmaceutical biotechnology environment.
• 2-3+ years in a Quality Assurance role.
• Proficiency in application of FDA 21CFR 211 and Part 11, ICH Guidelines, EU GMP regulations to supplier quality requirements.
• Demonstrated ability to meet timelines and achieve results in a team environment.
• Basic knowledge of drug development process, knowledge CGMP/GDP agency regulations (e.g., FDA, EMA, Health Canada, ICH), and ability to apply standards appropriately to situations.
• Past participation in regulatory inspections or audits is a plus.
• Excellent verbal and written skills, allowing for an open and effective dialogue between departments and clear communication to senior management on status and program needs.
• Ability to work independently and think strategically to improve current processes.
• Personal Competencies: self-awareness, integrity, problem analysis, communication, risk management.
• Interpersonal skills: team and consensus building, effective meeting management.
• Ability to work onsite in Cambridge, Monday through Friday.