REMOTE - Manager, Quality Systems
Reports to: Director, Quality Systems
Locations: Remote, USA
My client is seeking a Full Time Manager, Quality Systems, to join the Central Quality Systems and Compliance team. This role will interface globally with users across Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the enterprise Quality Management System (QMS).
Provide tactical and operational support to the Laboratory Investigation Report (LIR) Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing and learning program development.
Facilitate User Communities, and collaborative workshops to share information, drive continuous improvement and brainstorm new ideas.
Lead and support projects related to LIR, including QMS integration and continuous improvement endeavors.
Use deep process knowledge and experience to assist business partners with the creation, review, approval, closure and monitoring of quality systems records and associated quality risk assessments in compliance with internal and external requirements.
Proactively identify risks, issues, and best practices within the QMS.
Collaborate with global stakeholders to identify, plan and lead implementation of value-added improvements to the QMS.
On-time completion of assigned projects.
Author, review and approve QMS procedural documentation and working practice documents.
Participate in inspection readiness activities and internal/external audits and inspections.
Other duties as required to support the growing Quality organization.
At least 8 years + experience in a Quality role within the pharmaceutical industry, including prior experience having direct responsibility for the content and/or quality oversight of LIRs.
Expert knowledge of Phase 1 / Phase 2 OOS investigations for drug and device. Demonstrated critical thinking and problem-solving skills.
Prior experience within a global matrix environment across multiple time zones, including workshop facilitation.
Prior experience training and coaching for skill development.
Excellent communication skills with all levels of the organization and Health Authority representatives.
Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
Prior experience in a combination product company strongly preferred.
Prior experience conducting audits preferred.
Bachelors degree in a health care or life sciences discipline (ex. Chemistry, Biology, Biotechnology)