External Site Quality Lead (ESQL)

Job Description

An amazing opportunity has arisen for an External site Quality Lead. The incumbent is accountable for all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings, and company policies.

The incumbent also ensures that effective and robust Quality systems are followed to comply with required regulations, policies and guidelines governing the External manufacture of materials for the Company (e.g., small molecules active pharmaceutical ingredients, intermediates, raw materials) through direct oversight, support and technical advice, counselling to site leadership, and on-site supervision. The Associate Director may serve as a subject matter expert for EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the Company in forums on their area of expertise (both internal & external).

This position can be located within the United States of America, preferably close to one of our company's manufacturing sites.

Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Exhibits our company Leadership Behaviors and provides a leadership example for the team.
• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.
• Maintains and provides expertise on EQA systems, tools, data, and processes on an ongoing basis.
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
• May sponsor the interpretation and aggregation of financial/business data for EQA and highlight concerns as appropriate to EQA Management. Identifies and facilitates resolution of major deviations from financial or strategic plans.
• Accountable for oversight of an EE involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.
• Ensures permanent …