Quality Assurance Director

PURPOSE

Leads the Quality Assurance team, including Quality Systems and Quality Operations. Responsible for raw material inspection and release, Quality on the floor, disposition of drug product/drug substance, QA review of quality control data, root cause analysis, risk management, technical writing, deviation, change and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement.  Responsible for ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site. Help build scalable, phase appropriate Quality systems as the organization continues to grow.

ESSENTIAL JOB FUNCTIONS / DUTIES

• Act as a leader in the Quality organization, helping define and drive the Quality vision, mindset, and culture of the entire company in close collaboration with the Vice President of QA and Regulatory
• Develop overall program, implementation, and continuous improvement of the Quality Systems, which encompass but not limited to: QMS (Deviation, Change Control, CAPA), Documentation, Training, Supplier Management, Internal/Customer Audits and Customer Complaints.
• Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU applicable to gene therapy as appropriate for early phase clinical trials
• Develop, implement, and maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model
• Take lead role in evaluating continuous improvement options for the Quality Systems post initial implementation
• Responsible for supporting all client projects as the quality lead and attending all meeting for current and prospective clients.
• Develop user requirements and contribute to the configuration, validation, implementation, and lifecycle management of the electronic Quality Management System (eQMS - Veeva)
• Develop, implement, and oversee a Quality Supplier Management Program that serves all GxP areas including introduction and qualification of suppliers and materials, supplier material changes, supplier complaints
• Ensure that all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMP’s, US FDA, and EU requirements.
• Establish and continuously improve the Incoming Quality Assurance (IQA), Quality Oversight, and Batch Release programs
• Responsible for all raw material and final product release from the facility
• Establish department / individual goals and key performance indicators in alignment with company and operational goals
• Maintain and report applicable department and delivery metrics
• Establish the Quality Management Review Program, including facilitating creation of the presentation materials to include the Key Performance indicators, the meeting agenda, and attendance, and to orchestrate the material presentation
• Manage internal quality improvement initiatives: evaluate internal processes, suggest/design/implement improvements, create/revise relevant SOPs/Policies
• Act as subject matter expert and provide training on all Quality Management Systems, including but not limited to change control, quality events, investigation, and implementation of effective CAPAs
• Own and oversee the compilation of the Site Master File (SMF)
• Coach, train, and develop the Quality team
• Develop budget for department and ensure adherence to the budget
• Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
• Stay current with regulatory guidance as it applies to the Gene Therapy and early phase clinical trials
• Act as a member of the site leadership team and engage in business decision-making from a Quality perspective
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QA department

SPECIAL JOB REQUIREMENTS

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

KNOWLEDGE, SKILLS & EXPERIENCE

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

Work Environment

• Occasionally exposed to loud noise levels
• Position can be combination of remote and on-site
• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

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