Director, QA Validation

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeWe are seeking a seasoned Quality Assurance Validation Subject Matter Expert (SME) to lead the QA validation function at our sterile injectable GMP manufacturing site. The successful candidate will provide expert guidance and oversight for all aspects of equipment and utility qualification process and cleaning validation media fill activities process validation computer system validation and data integrity compliance. This individual will play a key leadership role in ensuring that validation activities meet regulatory expectations align with internal quality standards and support efficient compliant ResponsibilitiesServe as the QA functional lead for validation owning the quality oversight of validation programs for facilities utilities equipment processes cleaning and computerized and approve validation master plans protocols reports and risk assessments to ensure compliance with current GMP regulations guidance documents and internal QA oversight for media fill validations ensuring proper design execution and documentation aligned with sterile product manufacturing the QA review and approval of cleaning validation strategies including campaign rationale worst-case scenarios acceptance criteria and continued QA guidance during qualification of equipment and utilities (URS DQ IQ OQ PQ) ensuring appropriate risk-based approach and adherence to applicable QA review and approval of computer system validation (CSV) deliverables in accordance with 21 CFR Part 11 EU Annex 11 and GAMP 5 as QA approver and reviewer for periodic reviews and requalification strategies across validation lifecycle data integrity across validation documentation ensuring ALCOA principles are followed and integrated into all validation with cross-functional teams (Engineering Validation Manufacturing IT QC) to support timely project execution while upholding QA as the SME during internal and external inspections (FDA EMA customer audits) defending the sites validation and QA oversight and implement continuous improvement opportunities in the validation quality system and associated documentation and train QA and validation staff on current validation expectations and regulatory or advanced degree in life sciences engineering or a related 8 years of experience in GMP pharmaceutical manufacturing with strong experience in quality assurance oversight of validation understanding of regulatory requirements (21 CFR Parts; EU GMP; Annex 1; ICH Q8Q10; WHO PIC/S) and industry best practices (GAMP 5).Demonstrated expertise in sterile manufacturing validation particularly aseptic process simulation (media fill) cleaning validation and facility -on experience with computer system validation and data integrity controls in a GMP ability to collaborate effectively in a matrixed environment and influence cross-functional communication documentation and problem-solving experience representing QA validation during regulatory inspections strongly description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required. Role Holder may be asked to perform other duties as required#LI-Onsite#JJ