Director, Global Supplier Quality & Compliance

Job Description Director, Global Supplier Quality & Compliance – Remote (United States) Build your future at Curia, where our work has the power to save lives. The Director, Global Supplier Quality & Compliance, is responsible for providing cross-functional leadership to ensure the success of the Global Supplier Quality & Compliance program. Ensuring success at in the sites’ supplier quality program, coordinating and performing global on-site supplier audit program. Ensuring the quality and regulatory compliance standards at the global GMP sites, to ensure compliance with applicable agency regulations (e.g., FDA, DEA, EMA, MHRA) are proactively detected during global compliance audits, regulatory guidances, and Curia corporate objectives; Plays a lead role in driving inspection gap assessment and risk heatmap assessment for GMP facilties within Curia network. Coordinates and provides oversight for compliance harmonization and continual improvement initiatives at the global GMP sites. Other responsibilities include, leading the Center of Excellence (COE) team, administration of the supplier qualification process, performing supplier qualification audits, and administration of the Supplier Qualification Module within TrackWise Digital. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. We proudly offer Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more! Responsibilities Serve as a quality and compliance expert for manufacturing and R&D business units including drugs, devices and biologics Lead Curia’s global internal audit program Maintain risk based global internal audits, drive inspection gap assessments Lead Curia’s compliance benchmarking forum Coach and train site internal auditors Oversee COE activities Coordinate Global Supplier Quality program and ensure site compliance Including overseeing and conducting on-site supplier audits Drive quality/compliance harmonization and continual improvement initiatives. Anticipate future industry requirements and technologies, and build plans to integrate at Curia Coordinate and oversee regulatory inspection/audit readiness activities at the global GMP sites. Assist in the review of regulatory audit responses, as needed Provide on-site support during health authority inspections as needed Coordinate/perform periodic audits, risk assessments and gap analyses at global GMP sites to identify opportunities for improvement (gap analysis) and to support remediation efforts Ensure site implementation and compliance with internal global policies and procedures Coordinate/perform corporate audits of global Curia sites to support mutual recognition within Curia (e.g., Demonstrate control in the transfer of materials and services between Curia sites; Provide evidence of site inspection for QP release of batches to EU) Develop and/or review quality standards, policies, and procedures and support/monitor their implementation at global GMP sites (e.g., data integrity, sterility assurance) Develop job aid and risk assessment templates for site self inspection program using risk and quality system based approach Lead regulatory intelligence initiative to monitor emerging global cGMP requirements, regulatory hot topics and assess risk for Curia sites. Provide r…

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