Manager, Discovery QA

GlaxoSmithKline ,
Stevenage, Hertfordshire
More Details

Overview

Job Description

A rare and influential position is available as a Quality Assurance (QA) Manager focussed on ensuring the Discovery groups within GSK work to expected standards to ensure data integrity and compliance. You will manage activities relating to the Discovery QA programme, conduct assessments and provide quality and compliance advice and consultancy to the R&D functions generating non-GxP data ensuring its integrity. This role will allow you to gain a very broad understanding of compliance within GSK's Discovery work. Key Accountabilities * Promote a high level of quality awareness and compliance in business partner areas and project teams. * Develop strategies for the non regulated QA assessment/audit programmes. This will involve representation and influence at senior governance boards, in particular the non-GxP data integrity council. * Conduct and approve Assessments including reporting and CAPA management. * Write and Approve Procedures pertaining to Quality Assurance and business partners processes and systems. * Manage internal assessment schedule and ensure compliance with it. * Manage and Approve investigations, and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations. * Lead the preparation and hosting of GSK corporate inspections and responding to audits and/or inspections. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: * BSc or equivalent in Life Sciences * A broad scientific/pharmaceutical industry background in pharmaceutical research. * Extensive knowledge of scientific and industry practices of data quality and data integrity principles. * Detailed knowledge of the preclinical and discovery research processes. * Demonstrated ability to function effectively and strategically as a team member, and to communicate professionally and effectively with all levels of management and to negotiate persuasively * High degree of organisational awareness; good understanding of governance principles and control framework; and demonstrated ability to develop solutions to complex problems * Demonstrated and sound working knowledge with expert understanding of preclinical and discovery research activities * Demonstrated experience interacting and influencing senior managers. * Demonstrated ability to manage a globally based and culturally diverse organisation * Detailed knowledge of industry practices and principles of data integrity Preferred Qualifications: If you have the following characteristics, it would be a plus: * Quality Assurance Professional Experience. * Strong stakeholder management experience up to a VP and SVP level. * Inquisitive mindset, e.g. ability to probe and question process and advise the R&D teams. Why GSK? 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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. * Managing individual and team performance. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Implementing change initiatives and leading change. * Sustaining energy and well-being, building resilience in teams. * Continuously looking for opportunities to learn, build skills and share learning both internally and externally. * Developing people and building a talent pipeline. * Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. * Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. * Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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 fe

People also viewed