Global CMG Quality & Compliance Manager
- Wavre, Belgium
Site Name: UK - London - Brentford, Belgium-Wavre
Posted Date: Dec 10 2020
"Due to System limitations, only one site location can be listed as Primary. Please know that all site locations listed will be given the same priority."
The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants and patients administered GSK products, by ensuring the successful collection, assessment and reporting of safety data (adverse events).
This role ensures that case processing activities align with GSK standards for processing HSI and that regulatory timelines are achieved. This is done by ensuring Quality of CMG data and Compliance with Regulatory Requirements and company procedures.
The job holder ensures relevant Quality and Compliance-related oversight to the Case Management Group (CMG) Directors and drives the Quality and Compliance processes.
Core Liaison Accountabilities
- You work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements
- You generate new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes
- You monitor Key Performance Indicators (KPIs) ensuring compliance and quality thresholds are met and any metrics indicating missed KPIs are addressed.
- You give an input into Root Cause Analysis (RCA) and corrective/preventive action (CAPA) formation/effectiveness checks
- You do independent quality review of cases processed by vendor
- You ensure appropriate reporting activities are complete, as per Regulatory requirements
- You ensure that changes to Regulations are assessed for impact and any necessary changes are implemented, also providing awareness to QPPV Office.
- You support risk assessment and management of risk registers
- You supports Inspections/Audits (led by PVQA of Central/LOC/Vendor processes)/ LP Audits/ Regulatory Inspections (Central and LOC)/ Notified Body Audits
- You ensure appropriate management monitoring activities are complete
- Where problems or issues are identified, you ensure appropriate escalation and resolution
- You demonstrate GSK values during interactions
Management Liaison Accountabilities
- You manage a team of up to 10 scientific staff responsible for supporting quality/compliance
- You manage team to ensure appropriate prioritisation and time management, in line with business needs
- You build external relationships with senior leaders
- You ensure relevant Quality and Compliance-related oversight to the Case Management Group (CMG) Directors
- You resolve issues and concerns within the Quality and Compliance team and escalates to Quality and Compliance Director, where resolution is not possible or there is impact across CMG
- You ensure that all Quality and Compliance activities are appropriately resourced and escalates any resourcing issues
- You provide workload forecasts to CMG Directors and works with Quality and Compliance Director to strategically plan, in line with business goals
- You develop the team, identifying training requirements and working with training team to establish a training plan for individuals
Why you? Basic Qualifications:
- Degree in life sciences or medically related field or previous experience equating to educational requirements.
- Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
- Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
- In-depth understanding of medical and drug terminology
- Proven experience of Prioritisation and time management
- Strong communication skills
- Proven experience developing and delivering high-quality training
- Proven experience in line management
- Experience of using escalation mechanisms
- Health care professional (e.g. pharmacist or nurse) preferred.
- In-depth knowledge of GSK safety database preferred
- Knowledge of GSK products
- PV Quality and Compliance experience preferred
Our values and expectationsare 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 in a culture of Innovation, Performance and Trust.
GSK Vaccines- Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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