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.

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 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.

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 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.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing 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 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.

Pay Range: $117,000 - $146,500

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.

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