The Quality Systems Manager will be responsible for ensuring the Device & Packaging Development function has appropriate internal systems and processes to operate in compliance with health authority regulations for medical device and device combination products. This role is responsible for applying best practices, driving consistency & continuous improvement, supporting technical/systems excellence, and facilitating effective communication to enable optimum Device Team performance in a regulated environment.The Quality Systems Manager will be a member of the PTD South San Francisco Device & Packaging Development Business Operations function (PTDU-D). This function plays a key role to connect people, processes, and systems that enable compliant and agile team execution and deliver novel technologies & medicines to patients.
Job Responsibilities:Quality System Implementation & Records Management – Drive and sustain a quality-ingrained mindset throughout the department. Implement processes, systems & tools that support compliance & records management.
Global Pharmaceutical Quality System (PQS)
Influence, as the medical devices and device combination products representative, on cross-functional Global Pharmaceutical Quality System (PQS) teams and work streams ensuring design, development, industrialization, and commercialization requirements and processes are incorporated and that stakeholder voices are heard.
Manage the functions local impact assessments for Pharmaceutical Quality System (PQS) requirements and process changes.
Facilitate implementation of new and modified quality system requirements including but not limited to processes, systems, procedures, templates, and guidance documents.
Manage training and staff qualifications program to ensure compliance
Managing records and metrics for Change Management, Discrepancy Management, Complaints, and CAPA.
Manage site self-inspections, internal quality gap assessments & audits. Includes being a host, liaison, and WAR room leader.
Author response and remediation plan post audits & inspections.
Influence and maintain Data Integrity requirements and practices.
Drive Continuous Improvement efforts to assess how existing Knowledge Management practices and tools can result in quicker and better accessibility of information for device teams.
Manage and define the functions document retention practices to ensure compliance with company policies
Adapting existing processes and practices to align with IT landscape
Participates in monitoring the landscape of Digital Initiatives to identify opportunities to bring value to the function. Promoting strategy surrounding the functions software systems portfolio.
Provide technical expertise on cross-functional Digital Initiative projects as function representative and support in-house software implementation efforts.
Define Implementation Strategy for the functions software systems including system administration as key user, user training, user adoption, system upgrades/replacements, and system integration.
Monitor the effectiveness of software solution adoption through user pulse surveys and active user counts, etc. and assess the interconnectivity of software solutions within the function.
Manage the functions non-regulated and regulated IT systems such as audit trail software system, electronic notebook system, requirements management system, and knowledge management repositories.
Manage subscriptions to professional network associations and global Information providers such as AAMI, PDA, and GlobalNorm.
Who You Are:
B.S. degree or equivalent; preference for engineering or technical field At least 5-7 years’ experience in the Pharmaceutical or Medical Device Industry
Extensive knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical standards relative to device development.
Working knowledge of quality, regulatory, and systems pertaining to delivery devices and combination products