Associate- Change, Risk and Archival management

The Change, Risk & Archiving Management Associate supports pharmaceutical R& D business functions across Research, GLP, GCP & GVP by coordinating change control, quality risk management, and records management activities within RDQRM. The role partners closely with the Change Management

Business Process Owner, business representatives, and R& D Quality & Risk Management stakeholders to ensure changes, risks, and archiving-related activities are identified, assessed, tracked, communicated, and implemented effectively. A key focus of the role is supporting the revision and

implementation of the archiving process, including the URS update and the launch of a new SOP as a project deliverable.

Key Responsibilities

 Archiving Project: Support the revision of the archiving process, including URS updates, stakeholder coordination, and the launch of a new SOP to ensure a compliant and efficient archiving framework

 Archiving Project: Support the definition of archiving requirements for controlled records, retention, retrieval, and secure long-term storage in line with regulatory expectations.

 Monitor open changes and risks, follow up on actions, and provide regular status updates to RDQRM stakeholders.

 Maintain and manage the shared mailbox for changes, risks, and archiving topics, ensuring timely responses, correct routing, and clear communication with stakeholders.

 Facilitate weekly support meetings and act as a first point of contact for troubleshooting change-, risk-, and archiving-related questions from the business.

 Contribute to root cause analysis, issue escalation, and resolution activities when process deviations or implementation challenges arise.

 Support inspection readiness by maintaining accurate records and ensuring timely completion of assigned actions.

Required Qualifications

 Bachelor’s degree in Life Sciences, or a related field.

 Minimum of 3 years of experience in record management, change management, risk management, quality management, or a related role, preferably in pharmaceutical or biotechnology environments.

 Strong working knowledge of pharmaceutical R&D quality processes and GxP expectations, with exposure to GLP, GCP, and GVP preferred.

 Fluent written and spoken English.

Skills and Competencies

 Strong communication and interpersonal skills, with the ability to work effectively both independently and in a team.

 Excellent organizational skills and the ability to manage multiple priorities in a fast-paced environment.

 Strong attention to detail, especially in controlled documentation and archiving activities.

 Analytical mindset with the ability to interpret data, identify trends, and support continuous improvement.

 Comfortable facilitating meetings, following up on actions, and maintaining stakeholder alignment.

 Proactive problem-solving approach and a strong sense of accountability.

Preferred Qualifications

 Experience supporting regulatory compliance in GxP environments.

 Familiarity with archiving processes, controlled document management, URS preparation or revision, and SOP implementation projects.

 Experience with quality systems, data integrity, and regulated electronic records management.

 Familiarity with project management methods and tools.