Manager QA Compliance
Aseptic Manufacturing
Central TX

Great Compliance Manager Opportunity with Global Pharmaceutical Products Leader!

Excellent opportunity with Global Medical Products leader. The QA Manager is responsible for FDA and GMP compliance as this large aseptic manufacturing site. Responsibilities include: notification of new or changing regulations (FDA and worldwide) and cGMP trends relevant to our facility and dissemination of this information on a plant wide basis, development and maintaining the internal audit program and auditors, tracking and facilitation of remedial action for external and internal audits, supplier audit program management and quality metrics tracking. The Compliance Manager will design and manage and ensure the effectiveness of the Corrective Action/Preventative Action Process for the facility.  This will include coordinating investigation and implementation team activities; analyzing non-conformances for trends; and ensuring that all non-conformances are closed out in a timely manner with effective corrective actions.

Requirements:

• Minimum requirements are a Bachelor's degree in Sciences, engineering or related field with 5+ years experience in Operations and/or Quality Assurance. 
• Knowledge of drug regulations, quality systems, and auditing.  Basic Quality System knowledge (FDA/GMP, ISO 13485/13488). 
• Proven lead auditor skills. Strong computer skills (Excel, Powerpoint, SAP, Word, etc.). 
• Ability to communicate effectively with all levels of the organization.  
• Ability to effect change without direct responsibility for all levels of the organization.  Ability to thrive in a team environment. 
• Training with problem solving methods such as KTA's, HACCP, or equivalent.

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