Director, Quality Remediation

Curia • Town of Guilderland, NY

6d • $171,000 - $220,000 • Hybrid

About The Position

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.

The Director, Quality Remediation, is responsible to provide support to global Curia sites in Quality and Compliance remediation. This role requires leading compliance remediation initiatives at sites undergoing remediation. Responsible to drive regulatory commitments by collaborating with site leadership. Play a key role to implement Curia global quality standards and industry best practices to Curia site quality assurance program. Work with site quality heads to establish and maintain a risk-based and science-based quality system to protect the public health and to meet customer and Curia’s business needs and drive robust inspection readiness program. This role also requires to be on site for occasional interim site Quality roles.

Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering or related field
• Minimum 12-15 years’ QA/RA experience at USFDA, EMA regulated facilities, including 8 years’ experience in QA leadership or supervisory role
• Direct experience leading USFDA inspections
• Solid knowledge in FDA and other global regulations, especially the cGMP for the 21st century initiatives
• Strong strategic thinking skills and tactical skills to apply as needed
• Superior influential and negotiation skills
• Good people leadership capabilities and conflict management
• Strong understanding of organizational development
• Demonstrated ability to mentor and coach with the ability to motivate teams to reach a common goal
• Proficient in Microsoft Excel, Word, PowerPoint
• Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations
• Strong written and verbal communication and presentation skills including the ability to independently write and develop standards and procedures
• Ability to solve problems with a variety of variables using past experience
• Ability to interpret instructions furnished in written, oral, diagram, or schedule form

Nice To Haves

• Experience in Sterile, API and Biologics Products Quality Operations is preferred

Responsibilities

• Lead Remediation Strategy and Execution: Own the end‑to‑end remediation program for quality issues, from root cause analysis to sustainable corrective actions.
• Develop remediation roadmaps with timelines, milestones, and measurable outcomes.
• Prioritize issues based on risk, regulatory exposure, and business impact.
• Support GMP sites globally for remediation, for inspections & significant investigations Corporate Quality remediation lead and plays a key role in regulatory response development at the sites for major regulatory inspections
• Ensure the sites have a robust inspection readiness program
• Play a key role in the development of responses for inspectional observations, establish above site governance program to track CAPA commitments
• Provide support and management through a structured program to improve the efficiency in quality processes while maintaining the cGMP compliance
• Responsible for developing and leading Executive Quality Management Review as a delegate for the Head of Quality
• Support the sites to implement global training programs at the sites and ensure the sites have a process to execute them on a routine basis
• Support during regulatory agencies inspections and customer audits as applicable
• Ensure sites develop and execute quality improvement projects to drive the continuous improvement initiatives at the sites
• Embed Lean, Six Sigma, or similar methods into remediation work
• Promote understanding of and compliance to Sterility Assurance related regulations such as the FDA’s aseptic processing guide, EU Annex 1and other global regulatory agencies
• Lead and/or support major investigations related to sterility assurance events (i.e, Adverse EM trends, media fill failures, etc.)
• Identify opportunities to streamline processes and reduce defects
• Help build a culture of proactive Quality rather than reactive fixes
• Be available to take interim Quality leadership roles as necessary

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