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, Quality 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

COMPENSATION RANGE:

The anticipated annual salary range for the Director/Sr. Director is$170,000-$240,000. Salary determined based on relevant experience, skills and education.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment:

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; caustic chemicals; hazardous waste.
• Occasionally exposed to loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement:

• Frequently required to stand; sit.
• Occasionally required to walk; climb or balance; and stoop/crouch.

Vision:

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail