Job Overview
This role is responsible for overseeing quality documentation systems, ensuring compliance with regulatory standards and driving documentation excellence.
The position plays a key part in maintaining data integrity and enabling continuous improvement across quality control systems.
* Lead and maintain controlled documentation systems including SOPs, validation protocols/reports, CPV plans and technical documentation.
* Oversee the management and compliance of quality records generated within the QC department including test data, investigations and audit trails.
* Coordinate and support the lifecycle of Change Controls, CAPAs and Quality Investigations ensuring timely closure and regulatory compliance.
* Analyze QC data to support CPV activities and identify trends, risks and improvement opportunities.
* Ensure documentation and records meet regulatory requirements (EU GMP, FDA, ICH) and internal quality standards.
* Collaborate cross functionally to support validation, investigations and audit readiness.
* Develop and maintain dashboards or reports to visualize trends in process and QC data.
* Participate in internal and external audits providing documentation and technical support.
* Promote data integrity and continuous improvement across documentation and analytics processes.
* Train and mentor team members on documentation best practices, investigation writing and data analysis tools.
Requirements
To be successful in this role you will need:
* Bachelor's or master's degree in a scientific or engineering discipline (e.g. Chemistry, Biotechnology, Pharmaceutical Sciences).
* Solid experience in a GMP-regulated environment with exposure to QA, QC and validation.
* Strong understanding of CPV principles quality documentation systems and laboratory data lifecycle.
* Experience coordinating CAPAs change controls and investigations in a regulated environment.
* Proficiency in data analysis tools (e.g. Excel Minitab) and electronic quality systems (e.g. Trackwise Veeva LIMS).
* Excellent organizational analytical and communication skills.
Benefits
We offer a competitive salary package including:
* A range of benefits to promote work life balance.
* Ongoing training and development opportunities.
* The chance to work with a talented team of professionals.
* A dynamic and supportive work environment.
Inclusion and Diversity
We are an equal opportunities employer committed to diversity and inclusion.
Behaviors
We expect all employees to live and breathe our behaviors:
* Act with humility and build trust.
* Lead with transparency.
* Deliver with focus.
* Drive ownership always with unyielding integrity.