Quality Continuous Improvement & Project Manager

The QCIP Manager is fully responsible and accountable to manage complex projects and acts as leader in global campaigns relevant to Quality system implementation and compliance.
Supports development and deployment of the site QCI Master Plan. Builds strong relationships in their respective partnerships, becoming intimate with their mission, processes and requirements. Using robust change management skills, the QCIP Manager will drive major changes and communicate across the organization to ensure key stakeholders are aware and supportive of changes and their benefits, at all levels of the organization and locations as required.
Leads the design and implementation of improvement initiatives or events for processes that have a cross- functional impact to improve efficiency, reduce workload, reduce QC operating cost, and improve Quality unit performance while establishing a sustainable model for continuous improvement.
The Quality Continuous Improvement & Project (QCIP) Manager is responsible for identifying, strategizing, and implementing continuous improvement measures for Quality system operations using standardized tools to simplify processes, and improve compliance, quality, and efficiency.

Ensures standards (e.g. DMAIC, Lean, Root Cause Analysis) are being used for problem solving (tools and methods) and daily continuous improvement.
Trains and coach Belt candidates on Lean and Six Sigma methods, mentor candidates to completion and certification
Acts as a coach and change agent to instill a continuous improvement culture throughout the Quality unit and across functional departments.
Standardizes approach for and application of Continuous Improvement tools, and methods.
Manages Quality complex projects at global scale with local implementation to ensure timely deployment and successful maintenance

OTHER DUTIES AND RESPONSIBILITIES

Provides general support for other departments as appropriate, including identification/chartering/prioritization of improvement opportunities.
Coaches colleagues on standard work and project management
Other duties as assigned by Site Quality Head

MINIMUM QUALIFICATION REQUIREMENTS

A proven record of accomplishments in continuous improvement, complex QC/Quality Assurance/Technical project management, team leadership and problem- solving, demonstrated success initiating & managing change.
Bachelors degree in a technical field/science required, advanced degree preferred
Experience in applying systematic and rigorous analytical methods to improve processes, including the following methodology/tools: DMAIC, Value Stream Mapping, Control Plans, Mistake Proofing, Root Cause and Corrective Action, and other practical problem- solving tools.
Strong coaching experience and application of Continuous Improvement methodologies and tools.
Knowledge of compliance risk and other relevant US FDA and EU GMP requirements.
Practical experience in Lean and/or Six Sigma Black Belt or equivalent. Certificates are preferred.
Minimum 7 years experience in a similar role preferably in pharmaceutical, biotechnology or life science industry.
Excellent & effective English communications

SKILLS

In- depth knowledge of pharmaceutical manufacturing and QA/QC processes
Excellent team dynamics skills focused on strong team leadership and participation
Strong command in Project management and Change management
Expert- level in statistical methodologies applicable within pharma/biotechnology or relevant industry to support comprehensive problem solving efforts within Quality unit and across functional departments.

Ability to assess problem situations and adequately communicate the situation, resolution alternatives, costs and benefits, resource requirements, implications, and recommendations to senior management.
Skilled in Statistical QC 7 Tool, Gantt Chart, MS Project, Critical Path Method, and DOE.
Drive for results with a sense of urgency
Strong communication skills with all levels of the organization, emphasis on oral presentation skills, classroom training techniques, facilitation, coaching and feedback.
Ability to challenge current state and motivated to improve the factory quality processes; ability to influence without authority at all levels of the organization.
General knowledge of the ICH Q9 and Q12 is preferred

Chế độ bảo hiểm, Chế độ thưởng, Chăm sóc sức khỏe, Tăng lương

Cập nhật gần nhất lúc: 2023-12-09 07:05:17