Jobs

Associate Director/Pharmaceutical Manufacturing Site Head-Quality Assurance (cGMP)

Job Type: Full time / perm salary plus bonus

Key Words: Pharmaceutical/Quality Engineering / Quality Assurance/ cGMP (Good Manufacturing Practice)/Pharmaceutical Manufacturing

Location: Somerset, New Jersey-   # Remote position currently; 100% In House position after Covid

Job Description

Summary

This Associate Director-Quality Assurance is the Site Head of our Pharmaceutical Manufacturing Site based in Somerset, NJ. 

The position is remote during Covid but a 100% inhouse position post Covid.

Responsible for QA Oversight of the QA Release, Quality Engineer, and Supplier Quality Operations. 

A hands on position, manages a team of 4. Provides technical leadership to the QA/QC and Technical Operations organizations to ensure compliance to cGMP’s for marketed products and/or their raw materials, APIs, excipients or components. 

Key Responsibilities/Essential Functions

• Design, develop and implement a successful strategy for QA oversight within Manufacturing & Supply Chain of Pharmaceutical Company
• Provide technical leadership to the QA/QC and Manufacturing & Supply Chain organizations, and technical support for validation activities and Quality Event investigation and CAPA remediation. Provide technical guidance and direction to Third party/contract drug product and API Manufacturers.
• Review and approve deviations, CAPA and investigations. Ensures QE/CAPA are well written and comprehensive with through risk analysis assessments and use of root cause analysis tools. 
• *Interface with auditors from regulatory agencies and customers during in-plant inspections in relation to product testing.  Participate during internal audits and external inspections conducted by regulatory bodies. Ensure timely responses to noted observations and identify root cause.  Monitor and Implement CAPA’s to assure completion of any commitments made (Observations and CAPA’s).
• Must be hands on
• Must have experience with FDA Audits.
• Develop action plans, initiate, and employ continued training, development programs and assignments that further enhance technical skills and overall competencies of staff members and that contribute to succession plan for quality operations.
• Ensure staff members’ activities and operations are in alignment with all internal policies and requirements, in compliance with all external regulatory requirements, in a state of inspection readiness, and that they meet business objectives. 
• Maintain current, in-depth knowledge of all internal policies, procedures, technology, systems, and processes, and all related external regulatory requirements and guidelines.
• Ensure operations are within budget, and participate in budget process and cost savings initiatives.
• Monitor key performance metrics and communicate them to management team.
• Make decisions which effect product quality, regulatory compliance and the quality of product in the market place. 
• Actively promotes safety rules and awareness.  Demonstrates good safety practices at all times including the appropriate use of protective equipment.  Reports and takes initiative to correct safety & environmental hazards.

Basic Qualifications

• BS/BA degree in a relevant scientific discipline and a minimum of 7-10 years progressive Quality Engineering experience in the pharmaceutical industry
• Progressive relevant work experience in the pharmaceutical industry including: facilities/utilities oversight, *aseptic processing, formulation/filling and terminal sterilization.

Other Requirements

• Strong knowledge of regulatory requirements:  US/JP/EU and Canada