QA Senior Site Leader
GE Healthcare Bio-Sciences AB / Kemiingenjörsjobb / Uppsala
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hela Sverige Role Summary/Purpose:
This position is a key member of the BioProcess Quality leadership group leading a team with several direct reports. You are responsible for ensuring quality and regulatory compliance of the Uppsala facility, while driving process effectiveness and efficiency. The employee represents GE Healthcare to external agencies and champions the evolution of the quality culture for the site which includes executing and driving site quality objectives, metrics, reporting and operating mechanisms.
Essential Responsibilities:
• Accountable for ensuring full quality and regulatory compliance of the Uppsala BioProcess manufacturing facility, while driving process effectiveness and efficiency at the site
• Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews
• Maintains and improves all aspects of Site Quality Planning.
• Oversees all Quality-related communications and training requirements for all site employees.
• Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
• Ensures site audit readiness and hosting Quality System audits and inspections.
• Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs
• Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews.
• Drives the definition of site quality objectives, metrics, reporting and operating mechanisms.
• Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters
• Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
• Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics
• Participates in selected global initiatives to share best practices and leverage quality synergies.
• Supports local NPI programs and quality issue resolution.
• Acts as Management Representative for Quality at the Site.
Qualifications/Requirements:
• University Degree with a technical background
• Minimum of significant years working in a regulated medical device or pharmaceutical industry.
• Minimum of some years supervisory/management or project leadership experience
• Excellent communication skills in both Swedish and English (written and oral)
• Demonstrated experience using word processing, spreadsheet, and presentation software.
• Demonstrated understanding or aptitude to understand Biopharmaceutical & Medical Device QMS requirements, regulatory requirements & industry guidance, including but not limited to; US-FDA 21 CFR 820, 210, 210, ISO 9001 & ISO 13485.
• Experience of FDA, QSR, ISO, MDD and/or other international quality systems requirements.
Quality Specific Goals:
• Aware of and comply with the GE Healthcare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
Desired Characteristics:
• Proven process development and project management skills.
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
• Experience in a global, matrixed organization structure.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
• Demonstrated working knowledge to effectively communicate within all levels of the organization.
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
Publiceringsdatum2017-04-28Så ansöker duSista dag att ansöka är 2017-05-21
Klicka på denna länk för att göra din ansökanFöretagGE Healthcare Bio-Sciences AB
AdressGE Healthcare Bio-Sciences AB
Björkgatan 30
75184 Uppsala
KontorsadressBjörkgatan 30
Jobbnummer 3465695
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