Senior Specialist, External Quality Systems

Job Description

Individual contributor responsible for ensuring the compliance of External Quality Assurance (EQA) processes against approved quality manual documents and/or ensuring robust business systems in compliance with our Company policies.  The incumbent will be part of the EQA QRM CoE within the EQA Compliance/System team, which will provide Quality oversight of Quality and Business processes with EQA related to Quality Risk Management.  The incumbent will also drive and/or participate in cross functional initiatives to develop and optimize Quality systems and business processes.

The incumbent will be responsible for supporting the development, maintenance, and enhancement of critical processes and systems, Additionally, the incumbent will be responsible for compiling, analyzing, and reporting of associated metrics, supporting the development and implementation of strategic projects, as well as the development and ongoing monitoring of financial plans and performance.

The incumbent ensures that Quality Systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture of materials for our Company.  The incumbent may also be part of the team providing Quality oversight of internal inspection preparedness and performance of internal audits. The role could require routine interactions with all functions supporting the External Network, including interaction with functions across our Company’s global network.

Position Responsibilities:

• Serves as Quality SME for EQA; Maintains and provides expertise on EQA quality and/or business systems, tools, data, and processes on an ongoing basis.

• Ensures that the organization operates within established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.) both domestic and foreign.

• Provides support to the organization to facilitate and implement new quality systems introductions and/or improvements.

• Assists with and/or lead the development, and ongoing execution of the Quality Systems.

• Establishes new or improved processes, tools, systems and drives consistent, standard business processes across EQA.

• Supports the compilation, analysis and reporting of metrics, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.

• Supports audit/inspection readiness of the organization and participates in regulatory and other quality and compliance report-outs; review audit outcomes to ensure appropriate and timely corrective actions are implemented (where warranted).

• Provides project management support of EQA.

• Assists in the preparation and coordination of Quality Senior Management presentations at management conferences, training programs, Quality Council, etc. Operates in a safe and efficient manner and in compliance with the Safety and Health Policy.

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) degree in Science, Engineering, or related area of study with five (5) years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements; OR Master of Science (MS) degree in Science, Engineering, or related area of study with three (3) years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and regulatory requirements

Required Experience and Skills:

• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.

• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

• Communicates in English, both verbally and in writing. 

Preferred Experience and Skills:

• BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred.

• Prior management experie