Associate Director, Quality Assurance Operations

Invivyd, Inc.•New Haven, CT

3d•Remote

About The Position

There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers. At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024 , Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. In October 2025 , the FDA cleared the company's Investigational New Drug (IND) application and provided feedback to advance the company's REVOLUTION clinical program, Invivyd's development program for VYD2311, a vaccine alternative monoclonal antibody being investigated for the prevention of COVID-19. Be part of making a difference. Be part of Invivyd. Location: New Haven (Northeast Preferred) This position is remote but may require up to 20% travel to oversee/audit contract manufacturing organizations and meet with internal teams at the New Haven HQ. Position Summary: The Quality Team creates a breakthrough future as a value-added business partner by enabling innovation, productivity, and continuous improvement while ensuring adherence to applicable regulations and maintaining a focus on patient safety. The ideal candidate will be an experienced Quality professional and subject-matter-expert on Biological GMPs for products in all phases of development through commercialization. The candidate will act as a resource and provide guidance to the Quality department as well as partnering with Manufacturing, Supply Chain, and Process Development counterparts to incorporate value-added, fit for purpose, quality principles into the process. This is a hands-on position where the successful candidate works collaboratively as a business partner to ensure alignment on priorities and incorporates a science-based risk management approach to actions and deliverables. Quality CMC oversight of external vendors is a main component of this position. This position may require up to 20% travel to oversee contract manufacturing organizations. This position will report to the VP of CMC Regulatory and Quality.

Requirements

A bachelor's degree in a scientific discipline or biotechnology field
Minimum of ten years of experience in pharmaceutical industry with a minimum of five years in Quality Assurance, or masters/doctorate degree with commensurate level of experience
Strong knowledge and experience with ICH, USP, 21 CFR 210, 21 CFR 211, 21 CFR 600, and EMA regulations including vendor management
Expertise in applying GMPs for Development, Clinical Supplies, and Commercial Drug Substance and Drug Products
Extensive hands-on experience in: Biologics manufacturing and Quality Assurance
Vendor Management (qualification audits, quality agreements, relationship building) and presenting and defending Vendor Management program during regulatory inspections
Exception Management (deviation investigations, CAPA development, Change Control)
Product Complaints Management
Planning and conducting internal and external audits, authoring audit reports, and follow up on CAPA implementation and Risk Assessment to guide level of QA audits and oversight
Practical experience with building and maintaining Quality Systems for a virtual company is a plus
Experience in Risk Management and Commercial Quality Assurance operations is highly desiredExperience using Veeva Quality Vault
Build excellent working relationships with internal and external partners, working in a cross-functional team collaboratively and independently
Ability to proactively identify and determine impact of issues on GMP compliance and product development and commercialization and company needs
Ability to interpret GMP regulations appropriate for the phase of drug development
Ability to multi-task and adjust to changing priorities
Excellent written and oral communication and organizational skills
Ability to communicate complex information in a virtual environment
Strong attention to detail and good problem-solving skills

Nice To Haves

Experience with launch and commercialization of a biologics product is a desired

Responsibilities

Review and approve relevant GMP documents for compliance to Invivyd's Quality Management Systems and Health Agency regulations, including but not limited to: specifications, batch manufacturing records, stability protocols/reports, methods, and process validation documents
Work collaboratively with Manufacturing and Supply Chain counterparts to facilitate timely and effective resolution of process deviations, investigations, CAPAs, and batch record reviews, and to facilitate timely batch release/disposition to meet clinical and/or commercial needs
Participate in audits of GMP service providers according to appropriate Invivyd Quality Management System and regulatory requirements
Conduct Quality Management Review meetings with Executive Management to review the suitability and effectiveness of the Quality Management System
Create/revise SOPs as appropriate, including keeping up with SOP Periodic Review requirements
Upgrade Vendor Management Program by authoring/revising QA procedures as appropriate
Develop internal and external audit schedules and execute per audit plan
Apply Risk Management principles to qualification and oversight of external service providers
Participate in and manage regulatory inspections, including presenting and defending the GMP Vendor Management Program in regulatory inspections
Maintain current knowledge of GMP regulations and guidances, in particular, regulatory intelligence regarding vendor management expectations
Provide ongoing guidance and ensure compliance with established systems, process, and procedures
Assist in the development, implementation, and maintenance of GMP training and compliance programs for all company personnel involved in GMP activities
Partner with stakeholders on maintenance and implementation of other training across the organization (i.e., Clinical Quality Assurance, IT, HR, Finance, Corporate Compliance, Medical Affairs) to ensure full compliance