QA Manager

QA Manager

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Create and establish a scientific approach to the company quality and regulatory system.

Ensure all GMP, GLP, GCP operations are in compliance.

Establish training and audit programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and manufacturing records.

Develop strategies for regulatory approval and introduction of new products to market.

Manage the process from development of regulatory strategies through to approval.

Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval.

Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards.

Provide periodic update on regulatory requirement changes, which affect individual product specification or quality systems.

Foster collaborative, efficient and effective working relations with regulatory authorities such as FDA.

Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development.

Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials.

Act as company's representative during regulatory agencies and customer inspections

Qualifications

BS degree in Chemistry, Life Science or related discipline and a minimum of 10 years of relevant QA and Regulatory experience.

Familiar to solid dosage pharmaceutical manufacturing process with thorough understanding in GMP, GLP, GCP.

Expertise in regulatory filing and approval from phase I to phase III. Experience in effectively managing FDA inspections and customer audits