Quality ManagerReq # JR - 025132 Location Liverpool, England, United Kingdom Job Category Quality Control Date posted 08/03/2020
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The Quality Manager is the Management Representative with responsibility and authority for ensuring that the Quality System of the manufacturing facility is maintained to meet company and MOH requirements. The role will be responsible for ensuring compliance with all relevant regulatory requirements, that product quality requirements are met. Responsible for the promotion of awareness of both regulatory and customer requirements throughout the organization, and that periodic management reviews are conducted. The position is independent of manufacturing and related functions and fulfils the responsibilities of the 'Head of Quality Control'.
Essential Duties & Responsibilities
- Be an active member of the Plant senior management team and ensure product quality, safety, reliability and compliance related goals are established and implemented.
- Be accountable for driving a sustainable quality improvement culture
- Manage the day to day operation of the various departments and sections within the quality functions and their interaction with other departments within the Plant.
- Ensure the ongoing compliance with the company Quality System and local GMP requirements and manage interactions with all external regulatory bodies, agencies and customers to represent the company products and processes.
- Implement processes & procedures to ensure continued improvement of product quality, safety, yield, reliability and quality system compliance
- Manage the Quality function budget and identify opportunities for cost reduction and efficiency improvements
- Manage the training, development and coaching of members of the quality function to ensure the ongoing development of future leaders and technical personnel.
- Interface and manage relationships with regulatory bodies during inspections.
- Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Ensure systems are in place for effective Management Review.
- Responsible for batch release and ensuring the safety of products released from the Liverpool manufacturing facility.
- Ensure the Quality Department that any required expertise is maintained to meet business needs.
- Responsible of all site validation activities.
- Ensure that processes needed to maintain the quality management system are established, understood, implemented, and maintained.
- Ensure an effective internal quality assessment and audit program is in place.
- Manage and implement all QC activities to ensure process timelines e.g. product release, complaint response rate, are met.
- Responsibility for complaint investigation, including definition of investigation level, timeliness and quality of response and trending.
- Responsible for site CAPA review board
- Responsible for site change control
- Support Capex as needed
Education & Experience:
- BSc in Science, Chemistry, Microbiology or Engineering / Biomedical Engineering and an advanced degree to Masters level.
- Highly developed communication skills (verbal, written, listening, influencing, report writing).
- Strong leadership ability with a track record of innovation, performance enhancement, and change management
- Ability to deal with conflict
- Ability to prioritise and work effectively under pressure.
- Ability to remain calm under pressure
- Self-motivated and proactive approach to work.
- Problem solving and fault diagnosis
- Coaching and development techniques
- Motivational and influencing skills
- Financial awareness / budgetary control and information systems associated with manufacturing
- Knowledge of employment law as applied in the workplace
- The candidate is required to have extensive experience in operational experience in Quality, Engineering or a related discipline in a high-volume manufacturing environment with a minimum of 5 years’ experience in Quality at a senior level in a manufacturing environment producing pharmaceuticals or medical devices in compliance with EU GMP / FDA regulations.
- Experience in bulk API manufacturing and processes would be a distinct advantage.
- Qualified to Green/Black Belt Six Sigma or equivalent relevant experience.
- Experience in leading, managing and developing multi-disciplinary teams.
- Strong planning and organising ability (of own workload and that of others).
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.