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Senior Director, Quality & Compliance

Lead Candidate, Corona Del Mar, CA, United States


Lead Candidate are partnered with Forma Life Sciences as they seek an experience Sr Director of Quality and Compliance, to be based on site in Irvine, California. The ideal candidate will have a can-do attitude, and a proven ability in leadership of projects and people. Salary: ~$200k ???? Role Overview Lead Quality & Compliance for all GMP operations, ensuring regulatory and client requirements are met. Oversee QA team and approve batch records, validation, stability, and release documentation. Manage core quality systems including CAPA, audits, training, document control, and stability programs. Coordinate cross-functional activities to meet timelines and business goals. Drive continuous improvement of quality systems, processes, and compliance maturity. ? Key Responsibilities & Requirements Manage QA operations: deviations, OOS investigations, vendor qualification, audits, and product release. Lead regulatory inspections, client audits, and responses to observations and corrective actions. Oversee validation lifecycle for facilities, utilities, equipment, and GMP systems. Develop GMP metrics, training programs, and SOP improvements to strengthen compliance culture. Act as primary liaison with regulatory agencies and maintain GMP licenses and approvals. Please apply directly above or reach out to Paul@leadcandidate.com OR Zara@leadcandidate.com to find out more! Dont meet all the requirements? Dont sweat! Were always looking for an excuse to discuss your next opportunity. You might just surprise yourself Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.