Continuous Improvement Of Operations
QualityControlManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Quality Control Manager at Continuous Improvement Of Operations. Skills: Quality Control, Laboratory management, Regulatory compliance. Manage Quality Control laboratory. Manage quality management systems”
What You'll Achieve.
Ensure timely release of products; Meet company quality requirements; Meet customer quality requirements; Meet company timelines; Meet customer timelines; Ensure operations within approved budget
What They're Looking For.
Must Have
Excellent verbal communication, Excellent written communication, Ability to lead personnel, Ability to influence personnel, Feedback skills, Coaching skills, Mentoring skills, Current understanding of regulatory requirements, Proficient in standard MS software, Experience in biopharmaceutical industry, Previous supervisory experience, Direct experience in QC, Experience with quality management systems, Bachelor of Science degree, Bachelor of Arts degree, English Basic communication
Nice to Have
SAP experience
What You'll Do.
Manage Quality Control laboratory
Manage quality management systems
Oversee laboratory functions
Ensure operations comply with standards
Ensure products meet standards
Manage department for timely release
Prepare documentation for submissions
Review documentation for submissions
Partner with management for submissions
Employ operational excellence principles
Develop career paths for staff
Support career growth for staff
Oversee QC functions for manufacture
Oversee QC functions for release
Oversee contract testing
Oversee contract manufacturing
Represent Quality Control on Site Leadership Team
Represent Quality Control on Site Quality Council
Represent Quality Control on Material Review Board
Represent Quality Control on MPL Life Cycle Technical
Represent Quality Control on MPL Technical Team
Represent Quality Control on QC ASAT Team
Act as QC Management Representative
Develop departmental budget
Maintain departmental budget
How You'll Work.
Team & Collaboration
Inter-site personnel; Intra-site personnel; Site Leadership Team; Site Quality Council; Material Review Board; MPL Life Cycle Technical Team; MPL Technical Team; QC ASAT Team
Communication Scope
Verbal communication; Written communication
Full Job Description
**_Job Purpose_** Manage the Quality Control laboratory and related quality management systems associated with in-process and final release testing, Environmental and Utilities monitoring, product stability programs, and technical transfer of methods. **_Key Responsibilities_** The following key responsibilities apply to the QC Department. * Responsible for management of EH&S training, compliance and investigations in accordance with site and company safety and environmental guidelines. * Oversee laboratory functions to ensure that operations comply with appropriate regulatory standards and company policies, and that products meet appropriate standards for safety, purity, potency and quality. * Manage department to ensure timely release of products to meet company and customer quality requirements and timelines. * Prepare and review documentation for Quality Control sections in regulatory submissions. Partner with other management staff members to ensure timely submission of documents. * Employ operational excellence principles to bring about continuous improvement of operations. * Develop and support career paths and professional growth opportunities for Quality Control staff that will provide continuous improvement in product quality and operations. * Oversee Quality Control functions for the manufacture and release of GSK products on-site as well as contract testing and manufacturing facilities. * Represent Quality Control on Site Leadership Team, Site Quality Council, Material Review Board, MPL Life Cycle Technical Team, MPL Technical Team and QC ASAT Team. * Act as the Quality Control Management Representative during customer and/or regulatory agency inspections of the GSK Manufacturing Facility. * Develop and maintain departmental budget ensuring operations are within approved budget. **_Basic Qualification_** Skill * Excellent verbal and written communication skills. * Ability to lead and influence inter and intra-site personnel through feedback, coaching and
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