Senior Manager - Quality Management Systems, Veeva

Company: Affinivax, Inc
Location: Cambridge
Posted on: September 25, 2022

Job Description:

About AffinivaxAffinivax 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---This position provides the opportunity to work directly with Manufacturing, Facilities, Validation and QC stafffor continuous improvements of the Quality Management Systems with focus on Document Management.You will have the opportunity to---

• Be responsible for review and maintenance of Document Control procedures.
• Responsible for transferring Veeva documents.
• Be responsible for the organization of cGXP controlled documents in the Document Archive Room and electronic filing system to ensure that records are readily retrievable.
• Issue production batch records to support manufacturing operations.
• Provide support for implementation of upgrades or new eQMS platforms.
• Maintain KPIs for QMS pertaining to Document Control.
• Work with authors to coach them on generation of ALCOA compliant documents.
• Maintain audit readiness for their responsible areas.
• Assist a cross functional team with Deviation, Investigation, CAPA and Change control.
• Proficiency with MS OfficeWho you are and what you bring to the team---
  • A Bachelor's degree (or higher) in Chemistry, Biology, Engineering, or related field
  • 7+ years of industry experience (3+ years of QA experience) for a biopharma company
  • Experience with vaccines/biologics
  • Experience with Good Documentation Practices and knowledge of regulatory requirements
  • The ability to respond to changing priorities and expectations with a composed demeanor and foster effective cross-functional relationships
  • Excellent communication, writing and presentation skills for interfacing with internal and external organizations
  • Strong collaboration and team skills
  • The ability to think through the process and accurately apply and adapt regulatory standards
  • The ability to understand the QA function in a start-up entity and ability to make decisions on a go/no go criteria
  • The ability to work effectively within a variety of situations and adapt enthusiastically to changes in job demands
  • The drive to pursue tasks with energy, drive, and initiative; even in a fast-paced environment
  • Being comfortable in a results-driven, highly accountable environment where you can make an impact
  • Building productive working relationships across key groups at Affinivax
  • The ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressureWhat 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 SquarePlease Note: In accordance with Affinivax's 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.

Keywords: Affinivax, Inc, Cambridge , Senior Manager - Quality Management Systems, Veeva, Executive , Cambridge, Massachusetts