Quality Program Manager

Quality Program Manager in Albuquerque, NM

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Quality Program Managers will take the lead in ensuring compliance with cGMPs, company, customer, and regulatory quality standards according to requirements. Specifically, the Quality Program Manager will be responsible for directly interfacing with the CURIA-Albuquerque customers concerning all matters related to Quality. Additionally, the Quality Program Manager will work directly with the Site Head of Quality with customer-related issues.

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.

Essential Duties and Responsibilities

• Acts as the primary quality assurance contact for clients, CURIA-Albuquerque service department, and technical project management department. Responsible to ensure batch records have been thoroughly reviewed before release. Responsible for the release of product lots to the customer.

• Responsible for closure of customer complaint investigations. Recommends changes to all applicable SOPs. Analyzes data for trends develop continuous improvement plans and act on trends.

• Effectively coordinates functions of internal QA organization with the client and necessary CURIA-Albuquerque departments. Effectively communicates within the company and internal departments, outside vendors, and professional organizations. Interfaces with the other CURIA-Albuquerque Departments and customer service departments as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure the highest quality standards and regulatory compliance.

• Responsible for establishing and maintaining systems and procedures to ensure compliance of Curia -Albuquerque with all applicable regulations. Coordinates key systems including change control, inventory control, batch records (Manufacturing and Packaging), and other functions impacting the quality area and related to assigned products and clients. Supports CURIA-Albuquerque Compliance department during FDA and other agency inspections as well as customer and internal audits.

• Works with customers having products formulated or tested in defining quality systems specific to products or services being rendered. Makes formal presentations within the company, to customers at site-wide meetings and on-site-wide projects. Interfaces with all other departments to ensure coordination and compliance with SOPs and cGMPs.

• Provides all additional quality assurance support and functions as specified by the site head of quality. Ability to work promptly and under pressure to meet customer and business deadlines associated with batch record lot release.

Education and/or Experience

BS preferably in Science or a related field or equivalent experience. At least 10 years of industrial GMP experience in an FDA-regulated pharmaceutical environment. Proficient in Microsoft Excel, Word, and PowerPoint. Basic quality tools (i.e. pareto charts, histograms, cause-and-effect, root cause analysis)

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.

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 ~~~ email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.