Senior Manager/Associate Director, Quality Systems

Position Overview

The Sr. Manager/Assoc Director, Quality Systems supports the development and maintenance of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and internal quality standards. This role plays a critical part in developing and directing processes for Deviations, Change Controls, CAPAs, Product Complaints, Quality Risk Management, Quality Management Review, and Document Management and Control, all while driving continuous improvement and inspection readiness.

Key Responsibilities

Deviations, Investigations, and CAPA

• Support internal personnel in the understanding and execution of procedures related to initiating and managing deviations and CAPAs using the eQMS.
• Act as subject matter expert on the eQMS workflows that govern deviations, investigations and CAPA.
• Monitor status of open quality records in the eQMS as needed to facilitate on time completion with functional areas.
• Lead and/or support causal analysis exercises as needed.
• In partnership with Quality Systems Head, create and distribute metrics, analytics and performance indicators for the Quality Management System.

Change Control

• As assigned, coordinate and administer change control processes for GMP and quality-related changes.
• Provide support as needed to functional areas SMEs to initiate and manage change controls in the eQMS
• Monitor change control status and lifecycle metrics and work closely with internal teams to ensure timely approvals and closures.

Product Complaints

• Support the development and ongoing improvement of associated procedures for handling of product complaints. Partner cross-functionally with clinical and commercial SMEs to ensure robust process.
• Act as primary contact within Quality for the product complaint handling processes, including investigation, and documentation as needed.
• Collaborate with cross-functional teams to ensure comprehensive assessment of product impact and determination of appropriate actions.
• Trend and report complaint data to identify quality signals and potential improvements.

Quality Risk Management

• Support Quality Risk Management activities in alignment with ICH Q9 principles.
• When necessary, facilitate and/or support risk assessments (e.g., FMEA, risk matrices) related to processes, changes, deviations, and complaints.
• Ensure risks are appropriately documented, mitigated, and reviewed in the Quality System.

Document Control/Management:

• Support the day-to-day operations related to document control and GxP Document and Records management.
• Create/own SOPs and work instructions related to document/records management when assigned.
• Create and manage document templates for use with the EDMS/eQMS as assigned.
• Drive continual improvement and support ongoing implementation and configuration of eDMS in alignment with Immunome business requirements
• Develop and deliver training to personnel on how to navigate the document management system as well as author, review and/or approve documents in the eDMS.
• Provide SME support for audits and inspections such as providing documents, records and data from the eQMS upon request.
• Plan and implement system configuration changes that will enable continuous improvement to the document development and management process

GxP Training Administration:

• Act as supporting contact and SME for GxP Training Program Administration. Specific responsibilities include:
  • Support the creation and/or update to GxP Training Curriculum in eDMS/eQMS.
  • Provide training completion reports in support of QMR or other reporting needs\

Metrics & Continuous Improvement

• When assigned, generate and analyze quality metrics and trending reports for management review.
• Support the identification of process inefficiencies and contribute to continuous improvement initiatives.
• Support quality culture initiatives and promote adherence to quality principles across the organization.

Qualifications, Education and Experience

• Bachelor’s degree in life sciences
• 5+ years (Sr. Manager) or 8+ years (Assoc. Director) relevant QS experience in a regulated biotechnology, pharmaceutical company
• Hands-on experience with deviations, change control, CAPA, quality risk management, and product complaints.
• Excellent proficiency in Microsoft Applications, especially MS Word.
• Demonstrated experience working with data and ability to prepare and present in an effective visual format. Use of tools such as excel and/or smartsheet highly desired.

Skills and Competencies

• Strong understanding of GMP regulations and quality systems.
• Demonstrated proficiency with Microsoft Office (Word, Excel, PowerPoint) applications. Super user with MS Word features/functions and how that translates to document control systems.
• Proficiency with electronic QMS (eQMS) systems (e.g., MasterControl, TrackWise, Veeva, Dot Compliance), including set up / implementation experience.
• Excellent investigation and root cause analysis skills.
• Strong written and verbal communication skills.
• Detail-oriented with strong organizational and time-management abilities.
• Ability to work collaboratively with cross-functional teams.
• Analytical mindset with the ability to interpret quality data and trends.
• Excellent knowledge of data integrity principles and how to apply in the management of EDMS/eQMS.
• Continual improvement mindset with a proactive approach to problem-solving and process improvement.
• Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization.