Assurance qualit%C3%A9 Offres d'emploi - Parry Sound, ON

Manager, Clinical Product Development Quality Assurance

Pay :

110,000 - $150,000 CAD

Job Description : Purpose and Scope :

The primary purpose of the Manager, Clinical Product Development Quality Assurance (DPQA) is to lead the communication, facilitation and execution of the DPQA strategy to ensure high quality and compliant Clinical Trial Materials (CTM) are being manufactured, packaged, labelled, tested and released for clinical use in both regional and global settings.

This position provides Quality Assurance (QA) oversight of the execution of CTM (Clinical Trial Materials) activities associated with manufacture, testing, packaging, and distribution. With limited management support, Leads and progresses QA activities and processes for the identification and resolution of critical issues through risk management.

Serves as QA lead or representative on assigned project teams to provide direction regarding quality and compliance, to escalate compliance issues to management and to oversee completion of assigned quality related action items.

Essential Job Responsibilities :

• Manages overall Good Manufacturing Practices (GMP) QA support activities for multiple projects requiring CTM support for the manufacturing, testing, packaging and distribution for regional and global products in the development phase, including at third party manufacturers.
• Responsible for the timely review and approval of Contract Manufacturing Organizations (CMOs), technical documents (e.g. CTM batch records / GMP CTM Documents)
• Responsible for the timely review and approval of process related deliverables and changes during CTM phases.
• Manages supplier quality issue resolution by providing product specific knowledge / understanding.
• With limited management support, leads or supports the development and implementation of quality strategies associated with CTM.
• Responsible for the timely review and approval of process related deliverables and changes during CTM phases.
• Manages the development of new CTM Quality Agreements and facilitates periodic review of established CTM Quality Agreements with limited management support.
• Leads routine supplier audits. Participates in audits related to CTM new product introductions and new Supply Chain initiatives. Supports the CMO during regulatory authority inspections specific to product / project when necessary.
• Promotes product transition to CMC Product QA Commercial Readiness group through close communication and collaboration toward the product launch in each region.
• Promotes cohesive coordination and communication across functional areas in support of on-time delivery of CTM.
• Supports both regional and global new product introduction initiatives and responsible for building strong relationships across multi-functional disciplines.
• Serves as global QA representative on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.
• Evaluates development and / or implementation of local and global process improvement within Quality Assurance.
• With minimal management support, provides GMP and process improvement guidance to key stakeholders for processes governed by regulatory compliance requirements throughout the product development lifecycle.
• Supports the establishment of standards in support of quality systems and interfaces across multiple departments and levels of management. Authors / revises departmental Quality System Documents as necessary.
• Participates in the periodic review of Quality System documentation and contributes to management review activities.
• Participates in Quality meetings (Regional and Global) and communicates with appropriate QA personnel or key stakeholders regarding project specific information. Provides direction with management guidance for developing best practices and process improvements for project success.
• Leads or participates in assigned QA Working Teams which impact DPQA activity.
• Consistently promotes high standards through example and leads the team in a manner so each team member understands the standards and behaviors expected relative to quality and compliance.
• Performs other duties as assigned or special projects as needed.
• Qualifications :

Required :

Preferred :

Benefits :