This position is responsible for ensuring compliance of processes according to cGMP regulations. Also responsible for implementing, maintaining, and monitoring all Quality processes necessary for that assurance. This includes leading skilled people, running the operations according to cGMP regulations, and identifying and implementing business process improvements and that will drive business performance and Quality innovation. Incumbent provides technical expertise on Quality standards and processes to team members; provides strategic direction on specific departmental operations, and implements tactical planning within the department for daily operations.
Responsible for major organizational Quality functions such as SDLC, CSV implementation activities, QMS, Document Control, gDP, Risk Management activities, CAPA, electronic repositories, Quality documentation and Change Control.
Roles and Responsibilities:
• Plans, directs and manages the work of assigned Quality; provides technical leadership to corrective and preventive action (CAPA), deviation and change controls as necessary to ensure each project within the group is completed in accordance with departmental mission. Establishes department mission statements.
• Support validated systems of rfxcel by ensuring all validation activities are completed, maintained and regularly reviewed to ensure compliance to intended use
• Participation in External Audit, Support Director with site customer audits
• Provides oversight for the development of projects related to quality systems and continuous improvements programs.
• Proposes and executes process and procedural changes to improve process performance, robustness, productivity and efficiency. Applies metrics to departmental mission to drive continuous improvement.
• Collaborates functionally and cross-functionally to implement Quality strategy and objectives. Performs both independently and in team settings. Works closely with department Director to set and implement goals.
• Drive risk management activities, with the support of the director, within the SDLC and Change Control processes
• Serves as Leader for new initiatives relating to department. Removes barriers to successful implementation and works to resolve them.
• Ensures that all team members are compliant to all training materials and ensures timely completion of all trainings.
• Provide on-site training to teams to ensure comprehension of procedural updates and documentation of training records
• Requires a minimum of a Bachelor's degree in a science related discipline; Advanced degree preferred.
• Requires a minimum of eight (8) years experience within a Quality unit with demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• Minimum Four (4) project management experience in a regulate industry such as healthcare
• Strong understanding and appreciation for regulatory requirements and quality and compliance standards such as GAMP-5, ISO9001, 21CFR Part 11 and EU Annex 11
• Expertise is performing computer systems validations and collaborating with multiple departments to deliver all validation artifacts
• Requires strong collaboration, negotiation and ability to in a team environment and collaborate with peers.
• Overall understanding of Quality Systems and processes within a pharmaceutical / biopharmaceutical manufacturing organization
• Must have demonstrated abilities in goal setting, team leadership, staff coaching and development and communication.
Interested, can share updated resume to email@example.com with subject as QA Manager