Director/Sr. Director, Quality Assurance Operations

The role

The Director of Quality Assurance provides oversight for all elements of the Quality Management System to ensure compliance with global cGMP regulations. This role manages quality oversight for GMP functions including manufacturing, supply chain, and external suppliers while building a high performance Quality Assurance organization.

What you will do

• Manages development, implementation, maintenance, and improvement of Quality Management Systems.
• Provides guidance to operations on phase appropriate cGMP requirements.
• Manages investigations and implements timely and effective CAPA.
• Manages the review and disposition of raw materials, intermediates, drug substance, and drug product.
• Provides Quality Assurance support to Manufacturing, MSAT, FEV, Quality Control, and Supply Chain.
• Develops, implements, and improves Quality System Metrics and reports performance trends to senior management.
• Supports a risk-based internal and external audit program.
• Hosts and supports the management of PAI and routine global health authority inspections.
• Assesses the impact of new or updated regulations on Quality Management Systems and operations.
• Manages and maintains strong Quality to Quality relationships with clients.

Required qualifications

• Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
• 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 etc.)
• Strong written and verbal communication skills
• Strong organizational skill
• High level of attention to detail
• Good problem-solving skills
• Capable of working with minimal supervision
• Ability to work well with diverse groups
• Ability to multi-task in a fast-paced environment with challenging timelines

Nice to have

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

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Before you apply

• Criminal background check required
• Genezen is not able to sponsor visas

About the company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials. The company aims to meet the exacting needs of clients in the growing field of gene therapy.