QA Systems Manager – eQMS & CSV

MedPharm•Durham, NC

About The Position

QA Systems Manager – eQMS & CSV Projects: This will be a global position leading and supporting the implementation, migration, validation, and ongoing management of key electronic Quality Management Systems (eQMS) and pharmaceutical computerized systems across MedPharm sites in UK and US, ensuring equal support and alignment across all sites. This includes acting as a Subject Matter Expert on MasterControl, and other digital tools used to manage pharmaceutical quality data, ensuring compliance with GMPs, Annex 11, MHRA and applicable regulatory standards.

Requirements

Bachelor’s in Life Sciences, Engineering, Computer Science, or related discipline are desirable but not essential.
Training in Computer System Validation in a Pharmaceutical GMP environment and familiarity with GAMP 5 with minimum 5 years’ experience working in the pharmaceutical industry preferred.
Familiar with Quality Management Systems is desirable (Deviations, Change Controls, CAPAs, etc.).
Proven experience working with MasterControl, or similar eQMS platforms – configuration, administration, and user training.
Strong working knowledge with CSV and GxP system implementations in a regulated pharmaceutical or life sciences environment.
Hands-on experience with CSV activities relating to Empower CDS, including: Validation of new Empower installations and version upgrades Data migration and system archiving Management of audit trails, user access, and data integrity in Empower
Demonstrable success in leading system migrations or large-scale QMS digitalization projects.
Experience in writing and maintaining validation documentation in line with GAMP 5.
Good working knowledge of Computer System Validation.
Familiar with electronic quality management systems (eQMS).
Experience working within a Quality function on computer systems integration projects.
Highly organized
Effective communicator able to translate technical concepts to non-technical users.
Strong project management and organizational skills.
Able to influence and drive adoption of new systems across multidisciplinary teams

Responsibilities

To effectively manage key Pharmaceutical Computerized System projects: delivering according to plan.
To have a good working knowledge of electronic Quality Management Systems and its practical implementation at MedPharm.
Lead and support the implementation of new tools in the electronic Quality Management System (e.g., Master Control) across the UK and US sites, ensuring smooth transition and compliance throughout all phases.
Be the Subject Matter Expert (SME) for eQMS platforms including Master Control – provide training, troubleshooting, and ongoing support to staff at all MedPharm sites.
Own and manage system lifecycle documentation – URS, risk assessments, IQ/OQ/PQ, data migration plans, and SOPs, ensuring consistency, compliance, and alignment across UK and US sites.
To promote a culture of acceptance to change in support of ongoing programs of companywide improvement.
Provide regular updates to Senior Management and key stakeholders including consolidated site-specific and global metrics, ensuring that risks, issues, and progress are reported across UK and US sites
Support all employees across MedPharm sites working on Computerized System projects such as computerized lab equipment and validation activities.
Ensure adherence to GMPs, MHRA/FDA expectations and EMA requirements, Part 11, Annex 11 & 15, GLP, and latest industry guidance during project activities.
Ensure that all employees have access to training on key processes and are appropriately trained
Drive post-implementation reviews and continuous improvement of computerized systems.
To support the eQMS as a subject matter expert on Computer systems used to store and process pharmaceutical data.
Maintain compliance and audit readiness for GxP electronic systems and support audits and inspections of all sites across the network.
To act as the Records Archivist and manage archiving process.
Perform other duties as requested by management.