Description
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.
- Maintains an organizational structure capable of meeting both the immediate and long term objectives of the Quality areas under his/her responsibility.
- Prepares annual/update budgets for the sub department.
- Responsible for developing, implementing and maintaining the effectiveness of the quality system (Quality Documentation, Training and Supplier Quality departments.
- Owner of the Management Review process and related metrics tracking and trending. (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.
- Drive implementation of policies and procedures to maintain compliance to global regulatory requirements for policies, processes, and procedures.
- Manage broad and crossfunctional quality programs, initiatives and organizational change related to the AbbVie quality system.
- Lead goals with crossfunctional/crossdivisional/global scope.
- Ability to expedite and resolve issues. Elevate issues as appropriate.
- Responsible for Training Section and for the establishment, administration, and maintenance of a CGMP training program.
- Responsible for Documentation Section and for administration and maintenance of documentation control quality programs such as: Document Change Control, Document Retention, and Batch Record Archive, among others.
- Responsible for Supplier Quality Section and for the establishment, administration, and maintenance of a supplier quality programs such as:, CAPA system oversight, Supplier Quality Management and Supplier Qualification.
- Operates within the constraints of limited human and financial resources and changing priorities.
- Liaison with other AbbVie Sites and 3rd Parties.
- Participate fully and/or chair relevant Project team meetings.
- Actively supports functional work centers within Quality and Site to achieve goals.
- QC, Engineering, Quality Systems and Operations.
- Assists Quality Director with assigned tasks including budgetary control and key meeting preparations.
Qualifications
- 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.
- Shows a high level of tenacity to ensure closure of issues.
- Considerable planning and scheduling skills
- Ability to devise and implement systems.
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