Quality Compliance Associate

Integrated Resources Inc.; Collegeville (PA); On-site; USD 80,000 - 110,000; Full time

Job summary

Integrated Resources Inc. is seeking a Regulatory Compliance Manager to oversee change management and ensure quality assurance across contract manufacturers. The role requires strong communication, negotiation skills, and a degree in science or related fields, with a minimum of 5 years in a GXP setting. This position involves managing customer complaints and collaborating with various teams as the regulatory expert.

Qualifications

• Minimum 5 years in a GXP setting, or 3 with a Master’s.
• Strong verbal and written communication skills.
• Proactive with multi-project management capabilities.

Responsibilities

• Manage regulatory change activities and customer quality complaints.
• Participate in site quality visits and act as a regulatory expert.
• Collaborate on quality assurance practices across contractors.

Skills

Communication

Negotiation

Project Management

Education

BA/BS in Science, Engineering, Pharmaceutical Sciences, or related technical discipline

Tools

MS Office

Trackwise

Job description

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

• Our Global Quality Operations Mission is to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer-oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.

• Contract Operations Quality Assurance (COQA) drives excellence in quality by maximizing our partner collaboration to ensure patient confidence in our products.

• COQA is responsible for the quality management of approximately 300 contract manufacturers, packagers, and supply partners globally.

• The person will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM), management of routine complaints, and execution of lot disposition activities for the drug products and drug substances (APIs) manufactured by COQA-managed contractors.

• Initiate, review, and approve regulatory changes through the Regulatory Compliance Change Manager (RCCM) system and Product Dossier Manager (PDM) for changes initiated by or impacting COQA-managed contractors.

• Provide support for the closure of deficiency letters and CMC commitments, regulatory requests for renewals, new product registrations, and post-approval variations.

• Serve as the main point of contact for the Global Chemistry, Manufacturing, and Controls (GCMC) department or Local Regulatory Affairs (for single-market products) for various regulatory activities involving COQA-managed contractors. As the regulatory expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for COQA-managed contractors and, if needed, participate in site quality visits at the contractors.

• Manage routine customer quality complaints for commercial drug products in PCOM and collaborate with the COQA Contractor Quality Lead to ensure investigation reports are appropriate and acceptable.

• Ensure timely closure of complaints and alert relevant colleagues for confirmed complaints.

Qualifications

• BA/BS in Science, Engineering, Pharmaceutical Sciences, or a related technical discipline

• Minimum 5 years of experience in a GXP setting (or 3 years with a Master’s degree)

• Advanced computer skills, including MS Office applications and good knowledge of enterprise systems such as Trackwise

• Good command of the English language

• Strong verbal and written communication skills, with the ability to work in diverse, multi-level, cross-divisional, and multicultural environments

• Demonstrated negotiation skills and customer focus

• Ability to prioritize work, manage multiple projects, and work independently

• Proactive attitude with some travel required (up to 10%)