Quality Standards Manager

Summary of Position: 

The Quality Standards Manager is responsible for site Master Batch Records, Specifications, Analytical Methods, and SAP Material Master systems.  This role will serve as a working manager, accountable to maintain designated quality systems, including Specifications, Production Documentation, Analytical Methods, and related document control or quality systems to ensure delivery against Quality Assurance (QA) department goals and objectives. 

Organization Structure: 

The Quality Standards Manager reports to the Quality Assurance Manager – Documentation.  The Sr. System Administrator Quality Standards - Production Documentation and Sr. System Administrator Quality Standards – Specifications report to the Quality Standards Manager.  The role supports QA Documentation, QA Operations, QA Compliance, QA R&D, Quality Control, Operations and Product Development & Technical Services.  

Responsibilities: 
 

1. Production Records, Specifications, and Analytical Methods including:

1. Check all documents for general accuracy, alignment with current standards, and overall GMP compliance

1. Maintain all approved masters, supporting documentation, and associated systems

1. Coordinate approvals internally and with customers.  Issue records.

1. Create, change and maintain SAP data (i.e, material master, Q-info records, and inspection plans)

1. Monitor active files and discontinuation processes

1. Quality Assurance SAP Key User

1. Represent QA & Quality Control in development of new or revised SAP functionality and participate on the project teams for system development and validation

1. Train and qualify all required personnel to perform transactions required by their Job duties

1. Manage SAP material masters, retest/expiry monitoring, and cycle count reports on a monthly basis

1. Perform other SAP related responsibilities as required by QA Management.

1. Quality Improvement

1. Maintain monitoring systems to track performance, risk, and capability within QA.  Work with designated personnel to make improvements.

1. Lead and/or participate in projects and improvement initiatives to support department or site goals and objections.

Additional responsibilities may be assigned at the discretion of QA Management

Qualifications

BS/MS in Technical Field – Chemistry, Biology, Microbiology, Pharmacy or related field and 8 years minimum in a Pharmaceutical or FDA regulated environment or equivalent combination of education and experience.  Experience in Quality Standards, Quality Control, and document control required.

Decision Making: 

The Quality Standards Manager has the authority to manage work priorities and determine the appropriate documentation requirements for Production Records, Specifications, Analytical Methods, and related records to assure conformance with GMP documentation requirements.  This role has authority to author, review, and/or approve GMP records.

Additional approval authority for procedures, standards, and other Quality or Business considerations may be designated by Quality Assurance Management.