Customer Quality Lead (QC)

About the role

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.

Responsibilities

• Review customer test methods, method transfers, stability protocols, and responses to regulatory inquiries.
• Build strong professional relationships with customers, both during technical meetings and on-site customer visits to RLS.
• Monitor progress of agreed-upon tasks and escalate issues/delays when they arise, preparing contingency plans with internal partners.
• Understand and anticipate customer needs and support the organization and main stakeholders in the design of analytical experiments for new products.
• Build and maintain sufficient knowledge of 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.
• Coordinate and assist virtual customer audits in the QC lab as needed.
• Key liaison with business development & sales for all QC related deliverables required by the customers for new products & commercial product regulatory deficiencies.
• Coordinate with technical services, analytical development to ensure responses to customer queries are complete, accurate, and meet the requirements.
• Coordinate with Curia Albany site for any testing related requests for specific customer queries.
• Supervisory Responsibilities: Does not have any supervisory responsibilities.

Qualifications

• Minimum 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.
• Broad knowledge of cGMP, FDA, and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH).
• Familiarity with guidelines (e.g., FDA, ICH).
• Broad knowledge of pharmaceutical processes.
• USFDA inspection experience.
• Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders.
• Knowledge of pharmaceutical processes.
• Good understanding of the importance and use of quality metrics.

Physical Requirements

• Regularly stand, walk, sit, use hands to finger, handle, or feel, and talk or hear.
• Frequently reach with hands and arms.
• Sometimes lift and/or move up to 50 pounds.
• Occasionally climb or balance, stoop, kneel, crouch, or crawl.

Work environment

• Potential exposure to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).
• Exposure to moving mechanical parts, high, precarious places, outside weather conditions, and risk of electrical shock.
• Moderate noise level in the work environment.
• Exposure to hazardous waste for treatment, storage, and disposal.