Director, Global Supplier Quality & Compliance

Responsibilities

• Serve as a quality and compliance expert for manufacturing and R&D business units including drugs, devices and biologics
• 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
• Career advancement opportunities
• Develop and/or review quality standards, policies, and procedures and support/monitor their implementation at global GMP sites
• 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
• Maintain Curia GMP compliance risk registers for each business unit and collaborate with sites for mitigation strategies
• Maintain repository for regulatory inspection documents (audit reports, EIRs, responses) and metrics for global GMP sites
• This includes the regulatory inspection summary and classification of observations for presentation to Curia site and executive leadership
• Escalate critical or repeated observations from inspections/audits or serious compliance gaps to appropriate Quality leadership
• Participate in self-development activities to stay updated on the most current expectations for supplier quality by regulatory agencies and industry best practices
• Maintain up to date trainings
• Other duties as assigned

Qualifications

• Required Bachelor’s Degree in bioscience field or related study
• Minimum of 8 years working in site Quality Operational leadership roles with QA, RA, or Compliance experience in pharmaceutical industry at US FDA regulated facilities
• Experience must be with drugs, devices and biologics
• Broad knowledge of US and international cGMP regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7)
• Knowledge and practical application of state and federal regulatory as related to controlled substances
• US FDA/EU inspection experience (participating or leading)
• Auditing experience is preferred
• Experience with CAPA creation, execution, and effectiveness checks
• Prior supervisory experience in a pharmaceutical, CRO/CDMO environment
• Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders
• Good understanding of the importance and use of quality metrics
• Supervisory Responsibilities

Benefits

• 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!