R&D Computer System Validation & e-Compliance QA Manager

Site Name: UK - Surrey - Weybridge, USA - New Jersey - Warren, Richmond Sherwood Posted Date: Jul 22 2021 The R & D Computer System Validation & e-Compliance QA Manager shall provide lifecycle support to the deployment of all GxP software within Consumer Healthcare Research and Development (CHRD). The R&D Computer System Validation & e-Compliance QA Manager shall assist the R&D Quality Systems and Compliance Director in support of the upgrade and implementation of the CH Quality Management System (QMS) where it impacts GxP systems to assure it is aligned with regulatory expectation. The role will be available to provide subject matter guidance and representation for all applicable CHRD computer system initiatives as and when requested. This role shall ensure that digital software that impacts 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. The roles will also function as a subject matter expert on electronic quality systems used in R&D Quality. Key Responsibilities As the Quality and Compliance Authority for GxP software, this role 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 CHRD. Coordinate, enforce and follow up on all activities which impact the validated status of computerized systems within CHRD, and assist with CHRD global and local electronic compliance issues Provide the necessary subject matter support for all audit types in CHRD. 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 and CHRD 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 CHRD, this role shall independently determine and pursue courses of action to obtain desired functional and business objectives in the following areas: Support the CH Global e-Compliance & Digital Quality Lead with the production and maintenance of quality related procedures and material which impact CH and CHRD. Provide subject matter support to System Owners, third parties who develop and support Digital Applications, Service Providers and vendors. Maintain the CHRD GxP 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 As a Subject Matter Expert (SME) for electronic quality systems used within CHRD, this person shall support and assist R&D Quality colleagues Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Computer Science, Information Technology (IT), Chemical Engineering, Automation, Engineering Pharmacy, Biology, Chemistry, or a related technical field 5 + years' experience in the pharmaceutical industry 3 + years' experience in computer system validation, Quality Assurance, Quality Management, or Information Technology Governance Experience and knowledge in GxP Systems and software and electronic data which impact cGMPs, GLP, GCP, GDP, Eudralex, Code of Federal Regulations (CFR) and in Data Integrity within computer validation and digital applications Experience with the validation and maintenance of Digital Applications, Enterprise Systems, Process and Distributed Control Systems, Laboratory, Clinical, and Regulatory Systems and/or software Experience and understanding of the key expectations of the guideline documents supplied by FDA & MHRA, EMA, ICH, PIC/S and ISPE (GAMP) Experienced with, and thorough knowledge of, computer system validation (CSV) as defined by health authorities (FDA, EMEA, ICH), industry groups and the GSK QMS Experience and knowledge of: Quality Management; Project Management; Audit, e.g. Software Suppliers; Software Development Lifecycle; Change Control, Deviation and CAPA Management. Preferred Qualifications: If you have the following characteristics, it would be a plus: 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 Experience in international and multidisciplinary environments Results driven with a strong customer and quality focus 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. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.