We're seeking a seasoned professional to assume the role of Associate Director, Computer Systems Quality Assurance & Data Integrity. In this position, you will be responsible for ensuring the highest standards of product quality and compliance across our electronic systems and data integrity requirements.
The selected candidate will play a critical role in developing, designing, maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. This involves ensuring the quality, integrity, and compliance of GxP computerized systems, including manufacturing, warehouse and laboratory systems.
The ideal candidate will have a strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality Risk Management (QRM) and biopharmaceutical regulatory requirements. They should also possess deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation.
Additionally, the successful candidate will have experience with enterprise systems (e.g., TrackWise, Veeva, SAP), digital platforms, and automation environments (e.g., MES, DeltaV, DCS). Exceptional communication, cross-functional leadership, and decision-making abilities are essential for this role.
We offer a dynamic and supportive work environment where you can grow and develop your skills. Our team is passionate about making a difference in people's lives, and we're looking for someone who shares our commitment to excellence and innovation.
If you're a motivated and experienced professional looking for a new challenge, please consider applying for this exciting opportunity.
* Quality Systems and Data Integrity: Implement Global CS and DI Quality Standards, provide quality direction and governance, develop and maintain quality assurance procedures, conduct routine self-inspections, participate in IT and quality organizations, perform data flow mapping, ensure accurate documentation, oversee system change control, investigate deviations, develop comprehensive data governance frameworks, lead data mapping and flow assessments, collaborate with data owners, perform risk assessments, provide QA oversight, ensure systems are qualified and validated, support automation initiatives, review and approve system validation documents.
* Computer System Validation (CSV): Ensure all GxP computerized systems meet CSV requirements, oversee validation lifecycle from planning through retirement, provide QA review and approval for CSV deliverables, deviations, and risk-based validation strategies.
* Regulatory Compliance & Inspection Readiness: Maintain inspection readiness across all supported systems, stay current with industry regulations, guidelines, and best practices, interpret evolving regulations, assist in the preparation and execution of regulatory inspections and audits, ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for IT systems.
Benefits:
We offer a competitive salary and benefits package, as well as opportunities for growth and development. Our company values diversity and inclusion, and we strive to create a work environment that is welcoming and inclusive for all employees.
Required Skills and Qualifications:
* Strong working knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, Quality Risk Management (QRM) and biopharmaceutical regulatory requirements.
* Deep understanding of lab systems such as LIMS, CDS, ELN, and instrument software validation.
* Experience with enterprise systems (e.g., TrackWise, Veeva, SAP), digital platforms, and automation environments (e.g., MES, DeltaV, DCS).
* Exceptional communication, cross-functional leadership, and decision-making abilities.
Education:
A Bachelor's or advanced degree in Science, Engineering, Computer Science, Quality or a related discipline is required.
Benefits:
We offer a competitive salary and benefits package, as well as opportunities for growth and development. Our company values diversity and inclusion, and we strive to create a work environment that is welcoming and inclusive for all employees.