Job Responsibilities
Responsible for the organization, administration, training, development, and supervision of personnel under QA Documentation a..
Job 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 cross-functional quality programs, initiatives and organizational change related to the AbbVie quality system.
Lead goals with cross-functional/cross-divisional/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.
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 in pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment
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.
Requires knowledge of quality/compliance management as well as regulations and standards affecting APIs and Biologics
Experience in managing diverse teams is preferred.
Expected to demonstrate high levels of integrity and a strong work ethic at all times and ability to supervise a team including supervisors, contractors and trainees
Strong problem solving skills and highly independent
