Director, Global Supplier Quality & Compliance

Curia • United States,

4d • $158,000 - $197,600 • Remote

About The Position

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 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 facilities 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.

Requirements

• 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 of CFR and state guidelines as they apply to controlled substance activities
• Knowledge and practical application of state and federal regulatory as related to controlled substances
• Knowledge of pharmaceutical manufacturing and service-provider compliance processes
• US FDA/EU inspection experience (participating or leading)
• 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
• Proficient in building consensus, negotiating and escalating issues
• Good understanding of the importance and use of quality metrics
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Auditing experience is preferred

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 recommendations for mitigation strategies
• 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
• Lead training initiatives on quality/compliance topics to the global GMP sites routinely. Partner with the site compliance leaders and SMEs to ensure broad understanding and interpretation of relevant issues
• Perform other duties as may be reasonably assigned in the course of business
• 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
• Ensure timely escalation of potential issues and proposed solutions to line manager and Site Head as appropriate
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director