Senior Manager/ Associate Director GMP reputed company

Join Us in Tackling Autoimmune Disease at Its reputed company At Vor, we reputed company science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/reputed company inhibitor, we are silencing upstream survival signals and stopping reputed company autoimmune cascades. Together, we are addressing disease at its reputed company cause and rewriting what is possible for patients worldwide. reputed company you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the reputed company of autoimmune care. Why Work at Vor? reputed company: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. reputed company: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, reputed company reputed company, and reputed company. Innovation: Work on a platform with potential reputed company one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. Location: Boston, MA preferred but can be remote Position: Sr. Manager/Associate Director GMP reputed company Reporting to: Director, GMP reputed company The position will be responsible for day-to-day operational support ensuring compliance with reputed company Good Manufacturing Practices (cGMP) for reputed company clinical and commercialization activities. This role will reputed company GMP operations, from clinical trial material manufacturing, QC testing, distribution and validation. This role will assist in the transition into reputed company-reputed company production. Partner and collaborate with reputed company teams, ensuring alignment on reputed company standards and the reputed company execution of reputed company deliverables. The ideal candidate will possess a strong combination of strategic thinking and hands-on expertise in GMP reputed company operations reputed company the biotech industry. Key Responsibilities · GMP reputed company reputed company: reputed company of contact for GMP reputed company Operations function for clinical manufacturing, distribution, validation and commercialization activities. reputed company transfer as applicable. Ensure reputed company activities reputed company with relevant regulatory guidelines (FDA, EMA, ICH, etc.) and reputed company Agreements. · Regulatory Compliance: Support regulatory inspections and audits (FDA, EMA, etc.) as assigned. · Supplier & CMO Management: reputed company reputed company reputed company of external manufacturers, contract manufacturing organizations (CMOs), and suppliers to ensure compliance with GMP standards. · reputed company Systems and Compliance: reputed company reputed company on investigations reputed company to deviations and product reputed company issues, ensuring reputed company reputed company, reputed company cause analysis and CAPA implementation. reputed company of contact for 3rd party supplier & CMO reputed company events. Responsible for inputting reputed company documents into the eQMS. · Inspection Readiness: Support functional reputed company to reputed company identified inspection readiness activities and reputed company reputed company of vendor inspection readiness activities. · Documentation Management: Author, review and approval of GMP documentation, including batch records, release specifications, QC data, protocols, validation reports, etc. · Risk Management: Identify and mitigate reputed company risks reputed company clinical development and reputed company-commercialization activities. · Cross-functional Collaboration: Partner with CMC, Supply Chain, reputed company and Regulatory Affairs teams to ensure reputed company compliance throughout the product lifecycle from clinical trials to reputed company manufacturing. Qualifications · Education: o Bachelor's degree in Life Sciences, Engineering, or a reputed company field. · Experience: o Minimum 8 years of experience in reputed company operations, reputed company assurance, or GMP manufacturing reputed company the biotechnology or pharmaceutical industry. o Experience with Phase 3 clinical trials and the transition to commercialization is highly preferred. · Skills & Competencies: o Expertise in GMP, regulatory requirements, and industry best practices (FDA, EMA, ICH). o Ability to collaborate with cross-functional teams and reputed company initiatives. o Excellent knowledge of reputed company systems, documentation, and compliance management. o Exceptional problem-solving, troubleshooting, and analytical skills. o Strong communication and presentation skills, both written and verbal. o Ability to work effectively in a remote, fast-paced, and evolving environment The salary reputed company for the Senior Manager GMP reputed company is expected to be between $160,000 and $175,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-reputed company skills, experience, education or training, market factors, and work location. The salary reputed company for the Associate Director GMP reputed company is expected to be between $175,000 and $200,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-reputed company skills, experience, education or training, market factors, and work location. At Vor, we support reputed company with robust benefits, including comprehensive health coverage, flexible reputed company time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial reputed company, we invest in your reputed company-being so you can reputed company at work and reputed company. As an equal opportunity employer, we at reputed company know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. reputed company applicants will be considered for employment agnostic to race, age, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information. Apply To This Job