Global eCompliance & Digital Quality Manager
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
As a Global eCompliance & Digital Quality Manager you shall provide strategic and lifecycle support to the deployment of all GxP software, including digital innovations that impact a medical device within Consumer Healthcare (CH). The eCompliance and Digital Quality Manager shall assist the eCompliance and Digital Quality Lead in support of the upgrade and implementation of the CH Quality Management System (QMS) where it impacts GxP systems including Software as a Medical Device (SaMD) to assure it is aligned with regulatory expectation.
In this role will be available to provide subject matter guidance and representation for all applicable CH initiatives as and when requested.
You will also ensure that digital software that impacts SaMD and GxP systems and software operate within the framework of applicable health authority regulations (including but not limited to: Code of Federal Regulations 21 CFR part 11, Eudralex Regulations Annex 11, EN 13485 & EN 62304). In parallel all global policies and procedures shall be aligned with regulatory expectation and best practice.
In this role you will be expected to keep pace with the latest industry technology that impacts CH, including but not limited to Data Science, Artificial Intelligence and Digital Transformation to support the internal development and process improvements relating to the CH QMS.
Key Responsibilities include, but are not limited to:
As the Quality and Compliance Authority for GxP software, including digital applications that impact medical devices, this person shall:
Ensure that the companies’ policies and procedures for the specification, purchase, development and implementation of digital applications and GxP systems are ‘fit for purpose’. Act as a single point of contact (SPOC) for quality governance regarding the procurement of GxP computerized systems and digital applications, providing subject matter review and approval of key documents for the full lifecycle from implementation through to retirement for CH. Coordinate, enforce and follow up on all activities which impact the validated status of computerized systems within CH, and assist with global and local electronic compliance issues. Provide the necessary subject matter support for all audit types in CH. Audits may include but not be limited to due diligence, regulatory, supplier and internal assessments that impact the GxP systems and digital applications Maintain customer service relations and develop and sustain professional relationships that reflect commitment to GSK shared values. Foster communication and coordination across the CH eCompliance team and digital innovation Support global initiatives related to this subject matter (e.g.: Data Integrity)
As a Subject Matter Expert (SME) for GxP computerized systems within CH, including digital applications that impact SaMD, this person shall independently determine and pursue courses of action to obtain desired functional and business objectives in the following areas:
Support the Global eCompliance & Digital Quality Lead with the production and maintenance of quality related procedures and material which impact CH Provide subject matter support to System Owners, third parties who develop and support Digital Applications, Service Providers and vendors Assist the Global eCompliance & Digital Quality Lead in maintaining the Global System Register Support Inspection Readiness, including ISO Accreditation preparation, in close collaboration with Audit Coordinator(s); providing subject matter related support for follow up and/or remediation actions related to regulatory inspections
Closing Date for Applications: Friday 21st May 2021
*LI-GSK
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor of Science or equivalent professional experience Experienced in the pharmaceutical industry with specific experience in Medical Devices, Quality Assurance, Quality Management, or IT Governance. Profound knowledge in GxP Systems and software and electronic data which impact cGMPs, GLP, GCP, GDP, Eudralex, Code of Federal Regulations and in Data Integrity within computer validation and digital applications. Familiarity with the validation and maintenance of Digital Applications, Enterprise Systems, Process and Distributed Control Systems, Laboratory and Clinical Systems and/or software Good understanding of the key expectations of the guideline documents supplied by FDA & MHRA, PIC/S and ISPE (GAMP).
Knowledge of:
Quality Management Project Management Audit, e.g. Software Suppliers Software Development Lifecycle Software as a Medical Device (SaMD) Change Control, Deviation and CAPA Management
• Strong communication and negotiation skills (oral and written) and ability to negotiate and influence ‘best practice’ through positive communication with all business areas, data science, senior management, system owners, third party support organizations such as Digital, Technology, Off Shore Support and complementary workers
• Demonstrated proficiency and thorough knowledge of computer system validation (CSV) as defined by health authorities (FDA, EMEA, ICH), industry groups and the GSK QMS
• Experience in international and multidisciplinary environments
• Demonstrated attention to detail and organizational skills
• Commitment to GSK shared values with strong interpersonal and leadership skills
• Results driven with a strong customer and quality focus
• Willingness to travel sometimes at short notice
• Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization
• Ability to make decisions, evaluate risks and define and execute action plans
• Ability to propose innovative solutions to solve problems
• Fluent English required (written and spoken). Additional languages are a plus
