General Electric Biopharma Qara Training Manager in Amersham, United Kingdom
The QARA Training Manager is responsible for the development, execution and validation of the QA and RA training and development strategy/framework and resulting programs and processes for the global organization. In addition, the incumbent is responsible for assuring training programs support a regulatory compliance culture at LS Biopharma through skill-based learning and required employee knowledge.
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.
Formulating the project plans, establishing the priorities for training development and revisions in support of deploying standard and consistent QA/RA training across LS Biopharma.
Maintaining the Global QMS procedure for a) identifying individual training needs, b) ensuring appropriate personnel are trained, c) individual training needs and plans are documented and readily available.
Conducting global skill gap assessments and address through necessary education and training.
Understanding critical skills and abilities required to perform a role within the context of quality and compliance.
Ensuring all levels of employees has knowledge, skills, and abilities to consistently perform their job at a high level of compliance and performance.
Developing training content and delivery mechanisms and methods for different types & segments of training.
Work closely with the leadership within the QA/RA organization to ensure their training needs are being met.
Coordinate the training approach and standard practices for QMS procedures across all LS Biopharma sites and functions
Bachelor’s degree and significant working experience in Quality Assurance/Regulatory or equivalent knowledge or experience
Affairs or managing training activities across an organization. Alternatively, a High school diploma/GED and substantial working experience in Quality
Assurance/Regulatory Affairs or managing training activities across an organization.
Demonstrated experience working in a regulated environment, requiring adherence to government or regulatory body policies and procedures.
Demonstrated project management experience developing processes and leading their implementation in a cross functional environment.
Demonstrated ability to lead and influence behavioral change in a matrix environment
Demonstrated ability to effectively communicate (oral and written using English) across a cross-functional organization, up to business leadership and down to individual contributors.
Demonstrated experience successfully working with teams across many, cultures and/or work sites.
Prior experience and proficiency with word processing, spreadsheet, and presentation software
Quality Specific Goals:
Aware of and comply with the GEHC 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.
Ensure P&L or multiple businesses in his/her area of responsibility are able to execute the Training procedure and work instruction in a compliant manner.
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
Master’s degree and in experience developing, implementing and leading training activities or equivalent knowledge or experience
Prior Experience in Quality Assurance in Medical Device or Pharmaceutical industry Familiarity with FDA, ISO 9001/13485, training in a regulated industry, and other quality system regulations
Demonstrated ability to interface with top organizational leadership, internal/external customers and external regulatory agencies in a professional manner
Able to respond/react with appropriate urgency/professionalism & make decisions under pressure/stress
Ability to respond to escalated inquiries/complaints from customers, regulatory bodies & members of the business community
Influencing/advocacy-able to determine a position & argue it effectively within the business context
Familiar with continuous improvements in a manufacturing environment
Experience with Six Sigma, Lean and other Quality approaches
Effective interpersonal and networking skills
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