Customer Quality Lead (QC)

Curia Aalborg ApS; New York (NY); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Benefits package

Education reimbursement

401k program

Learning platform

Career advancement opportunities

Paid training, vacation and holidays

Job summary

Curia Aalborg ApS is seeking a Customer Quality Lead in Rensselaer, NY. You will join the leadership team to ensure QC deliverables meet timelines and regulatory requirements for customers.

The role involves reviewing test methods, stability protocols, regulatory responses, and acting as the main QC liaison with program managers and customers. Travel to US sites is expected as part of supplier audits and customer support.

Qualifications

• Master's degree in chemistry or related field.
• 10–15 years in QC/QA, API process development, or quality, in USFDA/EMA regulated environments.
• Strong communication, organization, negotiation and cross-functional collaboration skills.

Responsibilities

• Lead QC deliverables for customers ensuring on-time completion and regulatory compliance.
• Review customer test methods, method transfers, and stability protocols.
• Be the key contact with program managers and customers for QC inquiries.
• Build relationships with customers during technical meetings and on-site visits.
• Monitor task progress and escalate issues with contingency plans.

Skills

Leadership

Quality Assurance

Regulatory compliance

Cross-functional collaboration

cGMP knowledge

FDA/EMA regulations

Education

Master's degree in Chemistry or related field

Job description

Customer Quality Lead in Rensselaer, NY

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.

We proudly offer:

• 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
• And more!

Essential Duties and Responsibilities include the following:

• 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.
• This role will include a review of customer test methods, method transfers, stability protocols, responses to regulatory inquiries.
• Key point of contact with the program managers and customers for all QC related inquiries.
• Build strong professional relationships with customers, both during technical meetings (In-person or remote) and on-site customer visits to RLS.
• Monitors progress of agreed-upon tasks and escalates issues/delays when they arise preparing contingency plans with internal partners.
• Understands and anticipates customer needs and supports the organization and main stake holders in the design of analytical experiments for new products.
• Builds and maintains sufficient knowledge of site pipeline to understand the customer requests.
• Participate in customer meetings as required.
• Responsible to ensure all QAAs are reviewed and approved by the Curia and customer stakeholders in a timely manner for all QC topics.
• Responsible to work with stability team to ensure the stability samples of customer products are pulled and tested per site procedural and QAA requirements.
• 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.
• Coordinates with technical services, analytical development to ensure the responses to customer queries are complete, accurate and meets the requirements.
• Coordinates with Curia Albany site for any testing related requests for specific customer queries.

Supervisory Responsibilities:

Does not have any supervisory responsibilities.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position requires traveling as part of the job responsibility to perform the supplier audits and for onsite quality support in the US, NY.

Education, experience, certification and licensures Required

• Minimum Master of Science degree in Chemistry or a related field.

Experience:

• 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, 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.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk; and sit; use hands to finger, handle, or feel; and talk or hear. The employee frequent