Job description
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
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
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
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.
At GSK, we’re a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK’s values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it’s about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Apply via :
jobs.gsk.com
