at Bausch Health in Portland, Maine, United States
Senior Quality Systems Specialist (9217)
Career Opportunities: Senior Quality Systems Specialist (9217)
Requisition ID 9217 – Posted – Quality Systems & Technology – Quality – US – Remote More (1) – City (398)
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
ROLE TITLE: GLOBAL SENIOR QUALITY SYSTEMS SPECIALIST
DEPARTMENT: GLOBAL QUALITY SYTEMS & COMPLIANCE
REPORTS TO: MANAGER, QUALITY SYSTEMS
LOCATION: REMOTE -US OR CANADA
The (Sr.) Quality Systems Specialistwill use analytical, technical, and organizational skills and experience to facilitate the identification and implementation of process and systems improvements in a rapidly growing and evolving regulated business.
+ Be involved in the design or modification of Global Quality Systems processes
+ Create procedures and other process documentation as needed for the Global Quality System.
+ Support Global enterprise Quality Management System technologies such as ComplianceWire, TrackWise Digital, Documentum and another global or regional or even local technologies required support.
+ Drive / lead implementation of Global processes and technologies and support validation
+ Participate in governance of processes and technologies ensure best practices are respected.
+ Advise / participate in non-conformance, CAPA’s, Investigations, & Change Controls, document management and training.
+ Work with the business to identify opportunities for improvement in business operations and processes including the rollout of existing or new technologies.
+ Solve business problems and as needed, assists with technical solutions to ensure an efficient, effective and compliant Quality System.
+ Provide training and support on quality system processes and technologies
Education and Experience:
+ Bachelor’s Degree or equivalent experience in the Pharmaceutical or other life science-based industry (or substantial experience 10+ years in the industry)
+ Minimum 5 years of relevant experience required
+ Experience in one or more of these key quality systems:
+ Complaints Management
+ Change Management
+ Non-Conformances, Investigation, CAPA, OOS and Laboratory Investigation
+ Supplier Management
+ Document Management Auditing
+ Metrics and Reporting
+ Experience in technologies for eQMS such as Documentum, TrackWise, CATSWeb, ComplianceWire, SAP QM.
+ Global experience is preferred
+ Highly proficient with Microsoft Excel, Word, Power Point, Visio, Project and Teams, and other Microsoft products Required
Additionally, successful candidates will demonstrate:
+ Ability to influence
+ Experience successfully implementing change across multiple organizations with cross functional stakeholders is preferred
+ Familiar with pharmaceutical best practices, benchmarks and latest trends preferred
+ This position may require up to 10% travel
+ Strong technical writing skills
+ Multi – Lingual is a plus with English as a must.
This position may be available in the following location(s): Remote US and Canada
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Bausch Health is an EEO/AA employer M/F/D/V.