QA Manager

Integrated Resources Inc.; East Windsor Township (NJ); On-site; USD 100,000 - 140,000; Full time

Job summary

A leading staffing firm seeks a Quality and Regulatory Manager to oversee compliance and regulatory strategies within the pharmaceutical sector. The ideal candidate will possess substantial experience managing QA processes and ensuring compliance with regulatory standards. This key position demands a collaboration with regulatory bodies and leadership within the department to achieve quality excellence.

Qualifications

• Minimum of 10 years of relevant QA and Regulatory experience.
• Familiar with GMP, GLP, GCP.
• Expertise in regulatory filing from phase I to III.

Responsibilities

• Ensure compliance with GMP, GLP, GCP operations.
• Develop regulatory strategy and manage submissions.
• Act as the representative during regulatory inspections.

Skills

Regulatory Compliance

Quality Assurance

Team Leadership

Collaboration with Regulatory Authorities

Education

BS degree in Chemistry, Life Science, or related discipline

Job description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state's 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

Job Requirements

• Create and establish a scientific approach to the company's quality and regulatory system.
• Ensure all GMP, GLP, GCP operations are in compliance.
• Establish training and audit programs, review 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 updates on regulatory requirement changes affecting individual product specifications or quality systems.
• Foster collaborative, efficient, and effective working relations with regulatory authorities such as the FDA.
• Provide leadership and management within the department through objective setting, performance appraisal, and individual development.
• Be responsible for the release or rejection of GMP materials and utilize QA staff to manage timelines and ensure on-time delivery of approved materials.
• Act as the company’s representative during regulatory agency and customer inspections.

Qualifications

Qualifications

• BS degree in Chemistry, Life Science, or related discipline with a minimum of 10 years of relevant QA and Regulatory experience.
• Familiar with solid dosage pharmaceutical manufacturing processes with thorough understanding of GMP, GLP, GCP.
• Expertise in regulatory filing and approval from phase I to phase III, with experience managing FDA inspections and customer audits.