Purpose
The Quality System Manager is responsible to develop, manage and drive the performance of key Teams within ABS. This includes the Site Document Centre, Training Department and the Quality Administration function.
This role must maintain site personnel training in compliance with job function requirements and quality system policies and procedures. It is expected that Quality Systems Manager is actively focused on improving Training Systems in terms of structure, content and delivery across the Site.
Site Document Centre is expected to provide flawless and efficient support to all Departments and to support Manufacturing demands including turn around as a key part of the Site value stream process.
Site Supplier Quality Team is expected to provide Quality support to ensure implementation and maintenance of Supplier Quality oversight and programs to deliver quality products.
Responsibilities
- Responsible for the organization, administration, training, development, and supervision of personnel under QA Documentation and Training Area. The incumbent hires, trains, develops, evaluates performance, and administers following established personnel policies and procedures.
- Responsible for developing implementing and maintaining the effectiveness of the quality system (Quality Documentation, Training and Supplier Quality departments).
- Ensure compliance with applicable AbbVie policies, processes and procedures, contributing to the development of strategies and oversight of complex programs.
Requirements
- Degree or Higher in Science or Engineering discipline.
- Quality or Regulatory Qualification an advantage but not essential.
- A minimum of 5 years’ experience in a Quality or Project/ Program Leadership role.
- Strong communication skills, written and oral.
- Excellent knowledge of pharmaceutical regulatory requirements (GMP) is essential.
- Previous Leadership experience essential, 2 years min in either Project leadership or people leadership roles.
- Demonstrated change agent and innovative person.
- PMP software skills an advantage. – MS Project, Mind Manager etc.
- Quality/compliance management skills. This position requires knowledge of quality/compliance management as well as regulations and standards affecting APIs and Biologics.
- Minimum of 5+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
- Experience in managing diverse teams is preferred.
- Ability to supervise a team including supervisors, sole contributors, contractors, BOOST and ODP.
- Total commitment to quality and maintaining a high standard of work at all times.
- Requires proven problem-solving skills and the ability to adapt to new requirements.
- Is results driven striving to meet all targets and metrics as set by department/site and company leaders.
- Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project/department milestones are met.
- Considerable planning and scheduling skills.
- Ability to devise and implement systems.
