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.
We are recruiting to fill the position below:
1. Global eCompliance & Digital Quality SAP Manager
Job Title: Global eCompliance & Digital Quality SAP Manager
Job ID: 292471
Location: Agbara, Ogun
- The eCompliance and Digital Quality Manager for SAP in Consumer Healthcare will have primary responsibility for providing subject matter support for the compliant implementation, validation and maintenance of all ERP application software in CH.
- This person shall also provide strategic input and lifecycle support to the deployment of all GxP software, including digital innovations that may interface to any ERP application within Consumer Healthcare (CH).
- This role will 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 which also includes Software as a Medical Device (SaMD) to assure it is aligned with regulatory expectation.
- The role will provide subject matter guidance and representation for all applicable CH initiatives as and when requested.
- The role shall support the eCompliance team to ensure that digital software operates 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.
- This role will need 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.
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 all ERP related enterprise 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.
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).
- 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.
Application Closing Date
Friday, 18th June, 2021.
How to Apply
Interested and qualified candidates should:
Click here to apply online
Important Information and Notice
- 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.
- As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions.
- We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
- Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email to: email@example.com
2. Legal Director & Company Secretary
Job Title: Legal Director & Company Secretary
Job ID: 286494
Location: Ilupeju, Lagos
- To lead provision of legal, PLC compliance and company secretarial services and support to all the business units and entities in Nigeria/West Africa (WA) including CH, PH & CH Quality Supply Chain (QSC) to enable them achieve their business objectives in a manner consistent with applicable laws, regulations and corporate compliance principles.
- Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- The role will be responsible primarily for the provision of legal services across Pharma (Rx) in Nigeria and any other assigned markets from time to time – currently including Lebanon & Jordan in the Middle East (all together “the Markets”) and Consumer Healthcare (Cx) businesses in West Africa including leading / coordinating legal support and working and instructing outside counsel.
- The role will also be responsible for providing Company Secretarial cover in Nigeria
- The role holder will be managing/leading a management level lawyer and also interacting with other Legal Shared Services Team which delivers some specific legal services (e.g. corporate secretariat, contract cycle management, data protection, etc).
- The role holder will need to be flexible in terms of the type of work she/he is prepared to undertake and available to provide ad hoc advice on short notice. The following is illustrative of the key responsibilities:
- Participation in the Markets’ management team meetings;
- Negotiating/drafting and/or reviewing a wide range of commercial agreements;
- Providing legal support in respect of existing arrangements;
- Advising on Legal aspects of sales and promotion including review of product claims and challenges;
- Advising and managing commercial dispute resolution and litigation;
- Advising on legal entity and operating models;
- Providing legal support on industry issues, crisis management and product incidents;
- Oversight and management of legal risks within Risk Management and Compliance framework;
- Delivering/ coordinating Legal training to client groups – including, but not limited to, competition law, data privacy, anti-bribery and corruption, etc;
- Liaising with other groups within Legal (such as Legal Brand Protection, Dispute Resolution) and other departments such Corporate Tax, Finance etc)
- Appropriate and timely escalation of material issues to the Performance Markets Cluster Legal Director.
- Act as a business partner / trusted advisor to Rx and Cx Leadership Team (and the General Manager particularly) on all relevant legal matters impacting the Markets and educating client businesses on sound legal practices and new developments impacting the business.
- Support on other legal projects in the Markets as required according to business priorities.
- Anticipating and proactively supporting the prevention and management of legal risks facing the company.
- Manage and supervise activities of external legal counsel on legal matters in the Markets.
- Advising on compliance, governance and control issues where appropriate.
- Appropriately manage legal budget in the Markets so that alternative billing arrangements are reached with Law Firms and external legal services are provided at value.
Breadth/ Scope of Accountability:
- Number of Direct Reports – 2
- Annual Budget managed by this role – Annual Direct Revenue Accountability (please add currency)
Minimum Level of Education:
- University Level – Bachelor of Laws Degree.
Area of Specialisation:
- General Undergraduate Law Degree.
Why is this Level of Education Required?
- Basic technical competency minimum for Legal role.
Preferred Level of Education:
- University Level – Master of Laws Degree.
Area of Specialisation:
- Commercial & Corporate.
Why is this Level of Education Preferred?
- Advanced, specialized legal knowledge and theoretical frame necessary to handle complex legal issues.
Minimum Level of Job-Related Experience Required:
- Qualified as a Lawyer in Nigeria with more than 10 years of experience minimum.
- Experienced in commercial, contract, corporate and litigation.
- Experience of the Pharmaceutical, Consumer Healthcare and/or FMCG industries.
- Experience of operating in a multi-national, multi-cultural environment.
- Excellent communication (oral and written) skills. Fluent in English
- Ability to manage and work independently within a matrix structure and in a team environment.
- Ability to interact effectively and professionally with all levels of GSK management, but in particular senior GSK management and third parties.
- Qualified as a Certified Public Secretary or its equivalent with a minimum of 3 years of experience as Company Secretary preferably in a public listed company in Nigeria.
Why is this Level of Experience Required?
- Commensurate with the seniority level of the job as a leadership role
- Role requires ability to work independently and efficiently under pressure with minimal supervision.
Other Job-Related Skills/Background:
- Certified Public Secretary or its equivalent of good standing
- Member of the Nigerian Bar of good standing.
Application Closing Date
How to Apply
Interested and qualified candidates should:
Click here to apply online
- This is only general job description. Detailed business objectives for the employee are established during individual annual Performance & Development Planning (PDP) process and revised on current basis.
- The employee is obliged to perform all tasks and to behave in internal / external professional relations with respect to polish law, GSK policies and regulations such as: GSK Code of Conduct, Acceptable Use of IT Resources and so on (published in GSK network).