Associate Manager Quality Compliance
Maintains a leadership role in providing quality and compliance oversight of site operations, including manufacturing, quality systems, quality control, facilities maintenance, materials handling, and QA validation, in accordance with mandated regulatory requirements and site expectations.
Key Responsibilities:
* Ensures compliance with all aspects of quality for the Raheen site, inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
* Oversees site quality systems, including deviations, CAPA, change control, audits (internal and external), and customer complaints.
* Reviews and approves documents related to area functions, such as failure investigations, change control documents, corrective/preventative action documents, and standard operating procedures.
* Approves procedures, policies, and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
* Monitors and trends metrics for site quality systems.
* Manages and develops site risk assessment activities and site risk register.
* Participates in continuous improvement initiatives.
* Participates in regulatory and customer audits.
* Collaborates with functional departments to resolve issues and maintain compliance.
* Identifies gaps in systems and develops feasible plans for correction.
* Trains personnel on quality system processes.
Requirements:
A Bachelor's degree in a scientific discipline or related field is required, along with 7+ years of relevant work experience in the pharmaceutical industry.