Continuous Improvement Of Operations
Biopharma
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”
Industry & Context.
What They're Looking For.
Must Have
Excellent verbal communication, Excellent written communication, Lead and influence personnel, Feedback, Coaching, Mentoring, Regulatory requirements understanding, ICH guidelines understanding, FDA understanding, EMA understanding, Proficient in MS Word, Proficient in MS Excel, Proficient in MS PowerPoint, Biopharmaceutical industry experience, Previous supervisory experience, Direct QC experience, Quality management systems experience, 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 in-process testing
Oversee final release testing
Oversee Environmental monitoring
Oversee Utilities monitoring
Oversee product stability programs
Oversee technical transfer of methods
Manage EH&S compliance
Manage EH&S investigations
Oversee laboratory functions
Ensure regulatory compliance
Ensure company policy compliance
Ensure product quality standards
Manage department for timely release
Meet company quality requirements
Meet customer quality requirements
Prepare regulatory submission documentation
Review regulatory submission documentation
Partner with management for submissions
Employ operational excellence principles
Develop career paths for staff
Support professional growth for staff
Oversee QC functions for manufacture
Oversee QC functions for release
Oversee contract testing facilities
Oversee contract manufacturing facilities
Represent QC on Site Leadership Team
Represent QC on Site Quality Council
Represent QC on Material Review Board
Represent QC on MPL Life Cycle Team
Represent QC on MPL Technical Team
Represent QC 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; Other management staff; 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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