Continuous Improvement Of Operations

Biopharma

QualityControlManager

$9500–14000k ~AI est. Japan FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Biopharma

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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