Customer Quality Lead

Curia • City of Rensselaer, NY

3d • $117,000 - $146,500 • 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

• 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.
• 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.
• The employee is regularly required to stand; walk; and sit; use hands to finger, handle, or feel; and talk or hear.
• The employee frequently is required to reach with hands and arms.
• The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).
• The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required).
• The noise level in the work environment is usually moderate.
• Employee will be responsible for generating hazardous waste for treatment, storage and disposal.
• Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act.
• Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

Responsibilities

• 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 escalate 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.

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