【今市】Quality Control Manager

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 mentoring.
• Current understanding of regulatory requirements (ICH guidelines, FDA, EMA) for laboratory testing of bulk APIs/excipients.
• Proficient in standard MS software including Word, Excel, PowerPoint
• SAP experience preferred.

Experience

• Experience in biopharmaceutical or related industry, previous supervisory experience and direct experience in QC with quality management systems.

Education/certification/Language

• Bachelor of Science or Bachelor of Arts degree in a scientific discipline
• English: Basic communication

*Future scope of job and working location will be determined by company.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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