Senior Manager, QA - Validation

Company: Affinivax
Location: Cambridge
Posted on: January 22, 2023

Job Description:

About Affinivax Affinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next-generation approach to the development of vaccines and immunotherapies targeting infectious and other immune-mediated diseases. This novel and highly efficient vaccine technology called Multiple Antigen Presenting System (MAPS) enables the high-affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response. Our vision is to take a major step forward in vaccine innovation to prevent and combat a wide range of infectious and other immune-mediated diseases, protecting infants and adults in our communities and making a meaningful impact on global public health. Affinivax is focused on developing vaccines for the most challenging bacterial infections, with a goal of improving upon existing vaccines and providing solutions for where there are no vaccines or prevention strategies available today. The role Affinivax is looking for an energetic Senior Manager, QAV, to join the Quality Assurance team. We are looking for a candidate with excellent technical, operations, communication, and quality assurance skills. This position provides the opportunity to work directly with Manufacturing, Facilities, Engineering, Validation and QC staff to review and approve validation related documents. You will have the opportunity to

• Provide quality and compliance oversight for Commissioning, Qualification, Validation of Facilities, Utilities, Systems and Equipment.
• Review and approve project plans, SIAs, URSs, DQs, RAs, Validation protocols, Summary reports, SOPs, Specifications, and other applicable validation documentation.
• Work with a cross-functional team on validation related Deviations, CAPAs, and Change Controls.
• Support technical and quality investigations.
• Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities.
• Collaborates with functional departments to resolve issues.
• Demonstrate understanding and knowledge of Equipment Qualification, Utilities Monitoring and Qualification, SIP/CIP Validation, Lab Instrumentation Qualification, CSV.
• Additional duties and responsibilities as required. Who you are and what you bring to the team
• A Bachelors degree (or higher) in Chemistry, Biology, Engineering, or related field.
• 5+ years of industry experience in QA or Validation for a biopharma company.
• Proficiency with MS Office- Word formatting. Excel for analysis and graphing.
• Excellent written and oral presentation skills.
• Creative thinking, multi-tasking and ability to work in a matrix environment. What We Offer:
• Competitive compensation
• Medical and Dental plans (BCBS), employer-paid at 85%
• Vision Insurance, employer-paid at 100%
• Life Insurance, Short- and Long-Term Disability
• Flexible Spending Accounts/Health Savings Accounts
• Wellness Benefits
• 401(k) Plan with a 4% match
• Tuition Reimbursement
• Generous PTO package
• 11 paid holidays, plus Holiday Shutdown
• Pet Insurance
• Subsidized Parking
• Commuter Reimbursement Program
• Brand new facility in Kendall Square Please Note: In accordance with Affinivaxs duty to provide and maintain a safe workplace that is free of known hazards, we have adopted a COVID-19 vaccine policy to protect the health of our employees and their families, our visitors, and the community at large from COVID-19. This policy requires all employees, contractors, and temporary workers, to (1) obtain an approved vaccination and provide proof of vaccination or (2) request an accommodation for a medical or religious exemption. Our policy is based on guidance from the Centers for Disease Control (CDC) and Prevention. Affinivax is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, status as a veteran or as a member of the military or status in any group protected by applicable federal or state laws. Agencies: All resumes submitted by search firms/employment agencies to any employee at Affinivax via email, the internet, or in any form and/or method will be deemed the sole property of Affinivax, unless such search firms/employment agencies were engaged by Affinivax for this position and a valid agreement with Affinivax is in place. In the event a candidate who was submitted outside of the Affinivax agency engagement process is hired, no fee or payment of any kind will be paid. Powered by JazzHR

Keywords: Affinivax, Cambridge , Senior Manager, QA - Validation, Executive , Cambridge, Massachusetts