11 days old

Biopharma QA Computer System Validation Manager

GE Energy
Amersham, England HP6 6
  • Jobs Rated
    24th
Role Summary:

The Quality Assurance CSV (computer systems validation) manager facilitates and supports the definition, implementation and monitoring of global quality processes for non-product IT systems and drives the LS Biopharma strategy for all CSV activities. The role has authority to approve process, and provide an independent oversight to minimize the Company's risk exposure in compliance with applicable laws and regulations, and internal policies and procedures.

Essential Responsibilities:

GE employees may be considered for this role. Candidates should note that this role will be in scope for the proposed transition of GE Biopharma to Danaher and will transfer to Danaher at close of this transaction.





Position should be located in one of the following locations: Marlborough/Westborough MA, Uppsala SE, Amersham UK, other suitable locations may be considered for qualified candidates.





Key responsibilities include:



+ Establishes and drives LS Biopharma CSV strategy and standards across functional and product teams



+ Establish and maintain LS Biopharma Global procedures, work instructions and training elements related to Quality Management System (QMS) processes for non-product software and infrastructure.



+ Decision making authority for quality risk, compliance risk and mitigation controls for projects and processes.



+ Establish Global CSV non-product training processes and support scheduling, resourcing and delivery of CSV training elements to the LS Biopharma organization.



+ Provide support to sites and functions during regulatory inspections or third-party audit on Global IT Systems and Global CSV non-product QMS processes.



+ Provides independent oversight to assure that Global IT non-product software and infrastructure is selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.



+ Partners with IT compliance group in Global IT system validation and qualification projects and with IT Methodology group on Quality Management System (QMS) processes.



+ Approval authority of Global IT QMS processes and supporting training elements and QMS processes produced for IT projects.



+ Program budgets and/or cost centers, resource allocation and planning to ensure delivery of business benefits.

Qualifications/Requirements:



+ Bachelor degree in Science, Business, Engineering, IT or related discipline or substantial equivalent professional experience or equivalent knowledge or experience.



+ Significant experience with FDA Quality System Regulations, ISO, MDD and other international healthcare or life sciences regulatory requirements.



+ Experience making quality assurance and compliance decisions in regard to software development and validation and supporting quality systems.

+ Experience with all phases of software and infrastructure validation and qualification



+ Experience with all phases of System Development Lifecycles principles, processes and procedures



+ Strong leadership skills and demonstrated experience leading project teams. Ability to motivate team members.



+ Ability to establish a team strategy and link team and employee objectives to that strategy.



+ Demonstrated multitasking, project management and execution skills.



+ Ability to influence & negotiate at all levels of the organization.



+ Ability to read, analyze and interpret business plans, technical procedures, and governmental regulations.



+ Proven analytical and problem resolution skills.



+ Excellent verbal & written communication skills at the functional, technical, and executive level.



+ Ability to understand complex business processes and recommend simplification.



+ Experience in working as part of a "virtual team.



+ Experience with Microsoft Office products (Word, Excel, PowerPoint, Project and Visio).





Quality Specific Goals:



+ Aware of and comply with the Life Sciences Biopharma 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.



+ Proficient knowledge and understanding of Life Sciences Computer System Validation Procedures and associated Work Instructions and operates within them to ensure that all systems and application conform to specified requirements.





Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website http://www.ukba.homeoffice.gov.uk/visas-immigration/working

Desired Characteristics:



+ Experience applying Lean principles to simplify and improve processes



+ PMP / ITIL or equivalent certified.



+ GEHC experience

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GEs mission and deliver for our customers. www.ge.com





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.

Learn More About Careers at GE







Learn More About GE Healthcare







GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, and according with all local laws protecting different status.



Follow us on Twitter, join our LinkedIn Group or become a fan of our Facebook page. Receive job and event notifications by becoming a member of the GE Talent Community. Stay up to date on whats happening at GE around the globe by checking out the GE Careers Blog.Additional Locations:Sweden, United Kingdom, United States;Massachusetts;Amersham, Uppsala, Marlborough/Westborough;

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Jobs Rated Reports for Computer Systems Analyst

Posted: 2019-10-09 Expires: 2019-11-08

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Biopharma QA Computer System Validation Manager

GE Energy
Amersham, England HP6 6

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