Supervisor, Quality Control

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

The, Quality Assurance Supervisor is an integral part of the Curia team, contributing to our success by ensuring site compliance with applicable cGMP regulations including, but not limited to, overseeing the management of the site quality systems (i.e. change management, deviations, investigations, CAPAs, complaints) and ensuring that the principles of data integrity are consistently implemented at the site. The Manager, QA will ensure implementation of AMRI quality policies and standards and will drive continuous improvement activities based on the evolving regulatory requirements and industry best practices.

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.

• Assist the Director, QA with the development, implementation, and strict adherence to a quality assurance program. Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production and testing of all materials.

• Oversee the disposition of GMP materials. Oversee and assist with the site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications. Make recommendations regarding facilities, equipment, personnel, procedures, and systems to carry out the quality function.

• Ensure that the data integrity principles are understood and implemented consistently throughout the site.

• Responsible for customer on-site audits including the management of audit responses and CAPA plans.

• Review and manage customer quality agreements in accordance with company standards.

• Prepare and review quality complaint trends. Report serious or repeated failures or unreliability in quality of materials and/or services. Recommend corrective actions or plans/programs for overall defect reductions. Recommend and implement methods to increase the quality of materials and/or services.

• Collect, monitor and report quality metrics identifying and leading opportunity for improvements to achieve and maintain high quality standards and ensure customer satisfaction.

• Assist Director, QA during inspections by regulatory authorities. Implement inspection-readiness programs and ensure that proper CAPAs are prepared and completed on time.

• Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong quality culture site-wide while achieving the site business goals. This includes also leading and supporting site-wide cGMP training activities.

• Effectively communicate with internal and external customers making sure that the AMRI values and business goals are consistently achieved.

Required

• B.S./B.A. or M.S. degree in Chemistry or related field.
• At least five years of experience in the pharmaceutical industry in drug substance or drug product manufacturing, with at least 3 of those years being experience in Quality Assurance. Professional background not directly working in a QA function will also be considered given a relevant technical background and understanding of cGMP requirements.
• Strong knowledge of the pharmaceutical industry regulations applicable to API manufacturers, including FDA regulations.
• Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal.
• Strategic and critical thinking skills.
• Strong communication skills.U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.