Associate Director, Quality Systems

4 weeks ago


Watertown, Massachusetts, United States Affini-T Full time

About Affini-T Therapeutics

Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the ultimate goal of inducing long-term responses in patients with solid tumors.


Job Summary

Reporting to the Head of Quality Assurance, the Associate Director, Quality Operations and Systems, is a hybrid role that will be pivotal in supporting ongoing manufacturing and quality operations. Responsibilities include conducting timely batch record reviews, manufacturing deviations reviews, Out of Specification reviews, and collaborating with the CDMO's in ensuring timely disposition of drug product batches. Additionally, this position will support in managing internal quality system processes which includes the following: document control, training, change controls, deviations, CAPA, and product complaints to ensure compliance with internal policies and procedures.

Essential Duties & Responsibilities

  • Conduct timely and thorough batch record reviews to ensure compliance with regulatory requirements and internal procedures.
  • Review manufacturing related deviations and proposed Corrective Actions from CDMO.
  • Review Out of Specification (OOS) to determine and resolve issues related to product quality.
  • Collaborate with Contract Development and Manufacturing Organizations (CDMOs) to ensure timely disposition of drug product batches.
  • Support the Senior Director of Quality in managing internal quality system processes, including document control, training, change controls, deviations, CAPA, and product complaints.
  • Act as a Subject Matter Expert (SME) for document control and other quality system processes.
  • Maintain current knowledge of industry trends and best practices in quality management.

Required Qualifications


Education and Experience:

  • A Bachelor of Science in a scientific discipline is required and a minimum of 10 years of experience in Quality.
  • Experience with batch record review and batch disposition.
  • Experience in managing document control, deviation, and CAPA.
  • Cell and Gene therapy experience is a plus.
  • Preferred experience with outsourced manufacturing.

The successful candidate will have the following attributes:

  • Proven track record of building relationships and influencing across disciplines and all levels.
  • Strong interpersonal skills to effectively communicate with team, peers, Management, and external contacts.


  • Watertown, Massachusetts, United States Permanent Placement Resources, LLC Full time

    Medical OncologySamaritan Medical is building upon services at the newly opened Walker Center for Cancer Care and is affiliated with Roswell Park Care Network. Board certification or actively in process is required. As an employee of Roswell Park Care Network, candidate physician will join two other medical oncologists, two advanced practice professionals...

  • Future Zusers

    7 days ago


    Watertown, Massachusetts, United States Zus Health Full time

    Who we areZus is a shared health data platform designed to accelerate healthcare data interoperability by providing easy-to-use patient data via API, embedded components, and direct EHR integrations. Founded in 2021 by Jonathan Bush, co-founder and former CEO of athenahealth, Zus partners with HIEs and other data networks to aggregate patient clinical...


  • Watertown, Massachusetts, United States TeamHealth Full time

    Are you an emergency medicine (EM) physician looking to optimize your work/life balance? If so, TeamHealth has the perfect opportunity for you to join our team at Watertown Regional Medical Center. This Lifepoint Health System hospital as been renovated and had amazing updates done making this a top hospitalThis 16-bed emergency department (ED) is managed by...


  • Watertown, Massachusetts, United States Via Separations Full time

    Via Separations is a rapidly growing Boston-area startup dedicated to eliminating CO2 emissions from industrial manufacturing processes. At the intersection of engineering, society, and impact, our team is passionate about making a difference and building the technology and organization to do it. We are a fast-paced, interdisciplinary team backed by leading...


  • Watertown, Massachusetts, United States Mass General Brigham Community Physicians Full time

    About UsMGB Integrated Care is a system-led operating entity formed by Mass General Brigham to develop new high quality, low cost, innovative community-based ambulatory care. This work stems from Mass General Brigham's unified system strategy to bring health care closer to patients while lowering total health care costs. MGBIC will provide a wide range of...


  • Watertown, Massachusetts, United States Archway Physician Recruitment Full time

    Vascular Surgery opening in New York Located in Watertown, NY - Syracuse 70m Full-time, permanent positionPackage Highlights:Annual Salary $651,739; with additional WRVU productivity model (52 per RVU)Signing bonus: $100,000 Education Loan repayment: $20,000 each year Relocation reimbursement: $15,000 4-year contract with stable base A generous benefit...


  • Watertown, United States Affini-T Full time

    About Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of...


  • Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...


  • Watertown, United States ElevateBio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...


  • Watertown, United States Planet Pharma Full time

    Location: Waltham, MA - 3 days / week onsite Salary: AD - $175K + 20% bonus; Director - $200K+ 22% Bonus Top Skills Proven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness. Strong background in managing vendors effectively. Extensive experience with inspection readiness and...


  • Watertown, United States GForce Life Sciences Full time

    Internal Title: Quality Systems Specialist For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. Duration: 8-month contract Location: Hybrid - Waltham, MA (Onsite Tues, Wed, Thurs) Responsibilities: Assist in the governance of Quality System applications, including harmonization of processes...


  • Watertown, United States Ehub Global Inc Full time

    Title: Quality Systems Specialist 6-12 month contract Schedule: Mon-Fri (HYBRID onsite Tues-Thurs) KEY AREAS OF JOB ACCOUNTABILITY:(list of key objectives and quantifying standards) The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring...


  • Watertown, United States BostonGene Full time

    Position Summary BostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations. Responsibilities ? Ensure all activities are conducted in compliance with...


  • Watertown, United States Wolters Kluwer N.V. Full time

    Partner with the Health HRVP and LOB team to establish, drive, and manage the Division talent agenda in alignment with the Wolters Kluwer talent strategy and priorities. Partner with the Analytics COE to analyze metrics and qualitative data to provid Director, Talent, Associate, Management, Business Partner, Support, Technology


  • Watertown, United States Tome Biosciences Full time

    At Tome, we are developing the next generation of programmable genomic integration technology. Our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun. We have an opportunity to re-write the patient story,...


  • Watertown, United States AstraZeneca, plc Full time

    Gaithersburg, MD or Waltham, MA - Join AstraZeneca, a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the worlds most serious disea Director, Evidence, Associate, Clinical, Healthcare, Data Scientist


  • Watertown, United States Apex Systems Full time

    Job#: 2021948 Job Description: Senior Research Associate, LNP Formulations 2021948 Location:  Watertown MA (Onsite) Science:  CRISPR/Cas9 Therapeutic Area: Various Job Overview: We are seeking a motivated and detail-oriented Sr. Research Associate to join the Lipid Nanoparticle (LNP) Formulations team, contributing to the development of...


  • Watertown, United States ESR Healthcare Full time

    Emergency Department Director Watertown WI 53098 Job Type :Direct Hours :Full Time Required Education :Associates Degree Travel :No Relocation :No Job Industry :Healthcare - Health Services Job Category :Healthcare - Other Job Description : Description POSITION SUMMARY The Director, Emergency/Trauma Service (Director), under the general direction of the...


  • Watertown, United States Twin Cities Orthopedics Full time

    Don't swipe left on TCDC! Here's why; at TCDC you are not a number - you are part of a team that owns its future! TCDC is an employee-owned company with over 100 years in business and three locations. We value our employee-owners and their contributions that play an important part in our ability to provide our customers with precision aluminum and magnesium...


  • Watertown, United States Boston Dynamics Full time

    As Associate Director ML Platform on the Central Software team, you'll spearhead development and expansion of machine learning (ML) capabilities at Boston Dynamics. You'll oversee the design, implementation, and operations of infrastructure, and pipelines that unify how our many product ML/RL engineers and researchers get stuff done. If you are passionate...


  • Watertown, United States JobsRUs.com Full time

    JobsRUs.com is a service-oriented staffing/recruiting company dedicated to working closely with our clients We are currently hiring for Quality Assurance Assistant in Watertown, NY Pay: $24.00 - 25.00 Hours: Monday-Friday Responsibilities: Support safety, environmental, productivity and cost improvement efforts throughout the facility. Support the Quality...


  • Watertown, United States JobsRUs.com Full time

    is a service-oriented staffing/recruiting company dedicated to working closely with our clientsWe are currently hiring for Quality Assurance Assistant in Watertown, NYPay: $24.00 - 25.00Hours: Monday-Friday Responsibilities:Support safety, environmental, productivity and cost improvement efforts throughout the facility.Support the Quality Assurance...


  • Watertown, United States Landmark Bio Full time

    You'll lead a dynamic cross-functional team in producing clinical supply products under cGMP conditions. Your responsibilities include ensuring safe, high-quality, and efficient product delivery while fostering employee development and engagement. You'll play a pivotal role in establishing and optimizing Viral Vector and Fill Finish Operations during the...

  • VP, Quality Assurance

    3 weeks ago


    Watertown, United States Affini-T Full time

    Job DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...


  • Watertown, United States Landmark Bio Full time

    Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the...


  • Watertown, United States Twin Cities Orthopedics Full time

    Position SummaryWith an emphasis on die casting, this is a hand-on position focusing on providing support to production departments that leads to the addressing and resolution of quality issues through the use of effective problem-solving tools and techniques. While the primary emphasis will be on die cast quality issues, this position will also have include...