Director​/Sr. Director, Quality Assurance Operations

Lexington, MA

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The Director of Quality Assurance is responsible for oversight all elements of the Quality Management System (QMS), ensuring processes adhere to global cGMP regulations. This includes quality oversight of all GMP functions including but not limited to Facilities, Engineering, Validation, Manufacturing , Quality Control Laboratories, Supply Chain, Packaging and Labeling, Distribution, and external Suppliers.

The Director of Quality Assurance is responsible for building and motivating a high performance and innovative Quality Assurance organization which enables a culture of compliance, trust and accountability, efficient execution, collaboration for success, and integrity and respect in order to deliver transformative gene therapy medicines.

ESSENTIAL JOB FUNCTIONS

• Manages development, implementation, maintenance, and improvement of all relevant Quality Management Systems and processes to ensure compliance in line with global regulations and in alignment with the company’s strategy.
• Provides guidance to operations on phase appropriate cGMP requirements aligned with global regulations and internal Quality Management Systems.
• Manages investigations and implements timely and effective CAPA.
• Manages the review and disposition of raw materials, intermediates, drug substance , and drug product and ensures timely and accurate completions of reported quality events.
• Provides Quality Assurance support to the following operation areas:
  Manufacturing, MSAT, FEV, Q uality Control, Supply Chain.
• Responsible for developing, implementing and improving Quality System Metrics and for reporting performance trends and risks to senior management.
• Supports a risk - based internal and external audit program.
• Responsible for hosting and supporting the management of PAI and all subsequent routine global health authority inspections.
• Responsible for assessing the impact of any new or updated regulations on the company’s Quality Management Systems and operations.
• Responsible for developing and maintaining a high-performing Quality Assurance organization to effectively execute organizational responsibilities.
• Responsible for managing and maintaining strong Quality to Quality relationships with clients.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs.
• Criminal background check required.
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering

10+ years of relevant GMP experience in the pharma/biotech industry in a Quality role

Experience working in a cGMP manufacturing environment

Well versed in cGMP/ICH/FDA/EU regulations and guidelines

Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)

Strong written and verbal communication skills to interact with cross function teams

Strong organizational…