Customer Quality Lead (QC)

Curia • Rensselaer, NY

2d • Onsite

About The Position

The customer quality lead for QC will be part of the leadership team and will be accountable to ensure all QC deliverables for customers are completed on time and in compliance with regulatory requirements. Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 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

• Master of Science degree in Chemistry or a related field.
• Minimum 10-15 years QC, QA, API process development, technical services, or Quality for QC experience in the pharmaceutical industry at USFDA & EMA regulated facilities.
• Required working experience with global customers and global cross-functional teams.
• Broad knowledge of cGMP, FDA, and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
• Knowledge of pharmaceutical processes.
• USFDA inspection experience.
• Excellent communication and organizational skills.
• Negotiation, influencing, and collaboration skills.
• 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.
• Ability to travel as part of the job responsibility to perform supplier audits and for onsite quality support in the US, NY.

Responsibilities

• Ensure all QC deliverables for customers are completed on time and in compliance with regulatory requirements.
• Review customer test methods, method transfers, stability protocols, and responses to regulatory inquiries.
• Serve as the key point of contact with program managers and customers for all QC related inquiries.
• Build strong professional relationships with customers through technical meetings and on-site visits.
• Monitor progress of agreed-upon tasks and escalate issues/delays, preparing contingency plans with internal partners.
• Understand and anticipate customer needs and support the organization in designing analytical experiments for new products.
• Maintain knowledge of the site pipeline to understand customer requests.
• Participate in customer meetings as required.
• Ensure all QAAs are reviewed and approved by Curia and customer stakeholders in a timely manner for all QC topics.
• Work with the stability team to ensure customer product stability samples are pulled and tested per site procedural and QAA requirements.
• Coordinate and assist virtual customer audits in the QC lab.
• Act as a key liaison with business development & sales for all QC related deliverables required by customers for new products & commercial product regulatory deficiencies.
• Coordinate with technical services and analytical development to ensure responses to customer queries are complete, accurate, and meet requirements.
• Coordinate with the Curia Albany site for any testing related requests for specific customer queries.
• Generate hazardous waste for treatment, storage and disposal, understanding applicable training requirements, waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity, and improper disposal of hazardous materials.

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
• Learning platform

What This Job Offers

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