Quality R&D analytical labs Associate Director UK (Stevenage & Ware)

Job purpose: Serve as a compliance authority to ensure quality oversight and compliance within the Analytical Development team, supporting development and GMP analytical activities at UK sites. Ensure lab activities are conducted in accordance with GMP, local, corporate, and relevant international regulations. Foster a culture of continuous improvement and compliance. Manage stakeholder relationships to ensure effective communication with global R&D and maintain a unified quality voice with Quality teams.,

• Act as a compliance authority, providing fit-for-purpose quality oversight and maintaining quality standards from method development to release testing by performing gemba walks, coaching, and reviewing critical documents.
• Oversee Deviation, Corrective and Preventive Actions (CAPA), and Change Control processes, and perform operational quality oversight on laboratory operations.
• Manage and escalate issues appropriately to ensure timely and effective resolution, and drive quality initiatives to foster a quality culture and mindset.
• Ensure quality practices are fit-for-purpose and aligned across all supported analytical departments, providing risk-proportioned quality input to processes and systems.
• Perform shared quality activities linked to the site, such as Management Monitoring review and audit facilitation, and support local and global QR&D projects and support local and global QR&D projects, such as R&D QMS implementation.
• Prepare and support the R&D functions for audits conducted by GSK and/or external Health Authorities.
  
  We are looking for professionals with these required skills to achieve our goals:
• University (Master) degree in Sciences or equivalent, analytical expertise.
• Extensive experience in a quality or compliance role within the pharmaceutical or biotechnology industry, with a focus on R&D.
• Flexible thinking and risk-based approach methodology adept.
• Deep knowledge in quality regulation requirements covering GMP and general quality compliance. In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation
• Proven experience in managing and leading quality activities in an R&D environment, including audit facilitation and quality system implementation.
• Strong interpersonal skills with an ability to enable and drive change.
Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus:
• Ability to manage networks and build relationships transversally across the network. Experience of working with multi-functional teams.
• Excellent oral and written communication skills. Problem identification and solving skills.
  
  Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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 neurodiversity, 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., 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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK