Specialist, Quality Assurance - Records Management

The Records Management e-Data Specialist is a member of the Records Management Center of Excellence (RM CoE) responsible for the archival and lifecycle management of electronic records. This role ensures RM CoE-owned archived data — housed in repositories such as AWS S3, file shares, and SharePoint — is organized, maintained, and accessible in line with policy and service commitments.

Key responsibilities

• Perform annual reviews and clean-up of electronic archived records across RM CoE repositories to maintain accuracy, integrity, and compliance.

• Support archived data retrieval requests from business partners and stakeholders, delivering requested information within agreed service-level targets and assisting with audit requests as required.

• Maintain and monitor RM CoE-owned electronic repositories (AWS S3, file shares, SharePoint), including ongoing access control administration, routine health checks, and periodic retrieval testing.

• Contribute to data migration, decommissioning, retirement, and archival projects, coordinating with internal teams and external partners to ensure compliant and value-driven outcomes.

• Support administrative functions tied to RM CoE repositories such as documentation, change control, and configuration tracking.

• Produce and maintain project reporting, dashboards, and status updates to keep stakeholders informed of repository health and activity.

Education, Skills & Experience:

Qualifications: 

• Bachelor's Degree in Life Sciences, Engineering or related relevant discipline

• Minimum of 8+ years’ experience in the pharmaceutical environment or another regulated industry

• Capable of working and communicating effectively with cross-functional and cross-divisional partners

• Strong communicator with excellent verbal and written skills; ability to communicate effectively with global audiences

Required Experience and Skills: 

• Experience with reporting tools or analytics using Power BI, SharePoint, Excel, etc.

• Experience in computer systems validations and equipment qualifications

• Experience in document control management with GDP (Good Documentation Practices)

• Ability to follow written procedures, SOPs, and change control processes

• Self-motivated with a high degree of ownership and accountability for results

• Ability to prioritize time and problem solve to focus on the most impactful activities / initiatives

• Tracks, secures, and controls e-data archived inventories and are accountable for timely processing of records retrieval requests.

Preferred Experience and Skills:

• Experience with any content management, digital validation platforms, inventory management systems (Veeva, ECM, Kneat-eVal)

• Experience supporting audits

• Familiarity with regulatory requirements relevant to the industry (e.g. FDA, ICH, SOX, GDPR)

• Multi-Language preferred

• The ability to work in ambiguity, to problem solve, and to make rapid / disciplined decisions

• The ability to work with diverse personalities and to collaborate with global functions, global CoEs, and strategic partners

• Optimistic and positive when faced with adversity

• Continually evaluates RM Operational processes and effectiveness and implements continuous improvements where necessary

• The ability to take on greater responsibility in the organization overtime.