Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.
Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
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 Senior Specialist will be part of the EQA Compliance and Data Integrity Center of Excellence (CoE) within the EQA Compliance / System team, which will provide Quality oversight of Quality and Business processes with EQA and will also drive and / or participate in cross functional initiatives to develop and optimize Quality systems and business processes.
The successful candidate will be responsible for supporting the development, maintenance, and enhancement of critical processes and systems, and additionally, 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 role 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 and may also be part of the team providing Quality oversight of internal inspection preparedness and performance of internal audits.
The Senior Specialist, EQA Compliance DI CoE could require routine interactions with all functions supporting the External Network, including interaction with functions across our global network.
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
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
Education Minimum Requirements
Degree in Science, Engineering or another relevant technical discipline (e.g. BS / MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred)
Required Experienced and Skills
Minimum three 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
Effective and positive interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strategic relationships
Audit / inspection readiness and management, quality agreement management, internal audits, data integrity SME, metrics reporting and / or Quality Council
Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
Effective verbal and written communications
Preferred Experience and Skills
Strategic and effective Project Management
Quality Council Coordinator
Supporting regulatory inspections.
Conversant with all domestic and foreign regulations and compendia governing plant operations
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.