Associate Director, Quality Systems (Gxp)

Our clinical stage pharmaceutical client is growing and looking to add an Associate Director, Quality Systems (Boston or East Coast REMOTE) to their team! This role will provide leadership and expertise on quality systems applications, procedures, and operational activities. AD will act as a key Quality partner with other company functional areas, third parties and partners, perform as Quality system owner for Document Management and Training Management systems, including implementation of electronic systems. Other oversight items will include, document management, learning management, inspection readiness, electronic system implementation, process document authoring, training material development/delivery, metrics generation/communication, and support of change control, deviation investigation/root cause analysis, corrective and preventive action (CAPA), and supplier qualification. This role will support all GxP areas to ensure compliance of company's programs to phase appropriate GxPs, global legal/regulatory requirements, and applicable Quality policies/procedures. Other responsibilities include but not limited to:

Manage Document/Training Team responsible for:

• Routing and coordinating controlled documents for creation, revision, and obsoletion

• Routing, documenting, and tracking GxP training activities including departmental curricula and individual training plans/matrices

• Training material development and delivery

• Providing primary Customer Service point of contact for technical questions relating to the Quality systems and related processes

• Notifying staff of new, revised, or obsolete controlled documents or training assignments

• Maintaining training records

• Generating metrics and reports

• Document formatting

• Biennial (periodic) document review support and reporting

Serve as system owner for document management and training systems:

• Support Electronic Systems Implementation/Rollout and Updates

• Serve as business lead for development, continuous improvement efforts, and on-going maintenance of Quality e-Systems including, Document Management and Learning Management.

• Liaise with IT technical team and vendors throughout development to ensure business defined acceptance criteria is achieved for all system changes and projects

• Lead development of system fixes, enhancements, and upgrades - including developing user requirements

• Lead risk assessment execution for implementations, fixes, enhancements, and system upgrades

• Ensure high levels of system availability/functionality through effective testing - including user acceptance test script development and test execution

Support Quality Systems Continuous Improvement:

• Support development of streamlined processes and supplemental documents (including procedural document creation or maintenance) governing management and usage of Quality Systems

• Assist in the development and delivery of training for Quality Systems

• Maintain and distribute QMS related metrics

• Drive Quality Systems data quality improvements

• Support customer forums with the areas/departments detailing updates, opportunities, obstacles, etc. regarding the systems/processes

• Interface with other HilleVax functions to communicate best practices and identify / improve awareness and adoption of Quality systems and processes

• Support CAPAs stemming from audits, inspections, deviations and other Quality related assessments, as well as actions stemming from Change Controls

• Support audit preparations with respect to Quality Systems

• Own investigation of deviations and CAPAs related to Quality Systems

• Support change controls related to Quality Systems

Manages contract support that may be required to support execution of QA responsibilities.

Requirements:

• Minimum of a Bachelor's degree in a Science Field; Advanced degree in Science desirable or equivalent industry experience.

• A minimum of 8 years' experience in a pharmaceutical/biologics company with at least two (2) in a leadership role

• Experience with biologics/vaccines is preferred

• Excellent computer skills and advanced knowledge of Quality Systems. Direct experience with Quality Management Systems, Document Management Systems, and Learning Management Systems

• Veeva Systems experience preferred

• Quality e-system implementation/roll out experience - working with suppliers, system development, training delivery, and user acceptance testing

• Statistical reporting capabilities - metrics, key performance indicators and trending

• Proficient with Microsoft Office applications, Adobe, and document management templates

• Smartsheet experience a plus.

• Excellent interpersonal effectiveness, written/verbal communication, influencing and negotiation

• Formal or technical writing experience

• Knowledge of regulatory requirements for the pharmaceutical, biotechnology or vaccine industry required

• Advanced knowledge of global quality system requirements

Other:

• Location Boson, Hybrid -US East Coast preferred

• Willingness to travel (5-10%) to various meetings, including overnight trips.

• Some international travel may be required.