Quality And Systems Control Manager Jobs

Excellent project and data management skills and a keen attention to details

Experience in execution of internal audits and management of routine GxP inspections.

Manage ADCT Quality Event records, including Deviations, Change Controls, and CAPAs, to industry requirements

Support internal audit, inspection readiness, and inspection management activities

Other responsibilities as directed by manager

Ability to work independently and manage priorities in a remote setting while making sound quality/compliance-based decisions

Lead and direct team members to assist in maintaining the Quality management system.

5+ years of related experience in quality.

ISO 13485:2016 Internal Auditor Certification.

Experience with data process and statistical analysis.

Excellent verbal and written communication skills.

Excellent attention to detail and organization skills.

3+ years of People Management experience.

Demonstrated experience in executing quality management systems within heavily regulated environments.

10 years of Quality Systems experience.

Strong knowledge of domestic and international quality standards, including ISO 9001, ISO 13485 and/or other applicable regulations.

Experience in the healthcare, medical device, or pharmaceutical industry.

Lead investigations of incidents and accidents according to company reporting procedures, ensuring thorough analysis and the implementation of preventive measures.

Knowledgeable and experienced in: Lean, Six–Sigma, Process Approach Mapping, Project Management Practices and Data Analysis.

Required Knowledge, Skill And Abilities

Develop the Management Systems strategy, demonstrating solid progress against plan.

Regulate, Control, and improve the quality of all processes throughout the business. Lead the team to achieve quality management system targets.

Facilitate integration of other business aspects within the QMS, such as Safety, environment, efficiency – Total Quality Management mindset (TQM).

Minimum 10 years of relevant experience within a Manufacturing environment in a similar capacity

Establishing, supporting, maintaining, monitoring QMS framework processes and robust quality systems management program in compliance applicable global CMC/GMP requirements

5+ years of quality system management experience in a GxP regulated environment

You are enthusiastic about applying your expertise in quality systems management

Leading the management of Quality System execution, including Deviation, CAPA, Change Control, Complaints, as applicable

Ensuring timely and accurate reporting via Quality Review Boards/Management Review on the performance of AbCellera’s QMS, along with associated required improvements

Experience in GMP manufacturing, and testing requirements for biologics, including aseptic technique/operations, environmental monitoring programs, and media simulation studies

Owns management and oversite of Technology Investigation Projects (TIP), processes, and facilitates consistent execution and stakeholder management

Typically requires a minimum of 5 years of product development management

Delivers and supports the deployment of scalable, enabling, and re-usable engineering content to the development team and associated knowledge capture.

Demonstrates strong Leadership by influence capabilities and commitment to developing strong relationships and collaborative partnerships internally and externally.

Bachelor’s degree in Electrical Engineering, Engineering, Computer Engineering, Computer Science, or similar technical discipline, or equivalent work experience

Typical requires a minimum of 5 years of experience in engineering leadership.