What are the responsibilities and job description for the Analytical Quality Labs Associate Director BST position at GSK?
Posted Date: Jan 31 2025
As the Analytical Quality Labs Associate Director BST you will serve as a compliance authority to ensure quality oversight and compliance within the Analytical Research and Development (ARD) team, supporting development and GMP analytical activities in the Boston area.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Ensure labs activities in Binney Street GSK site are conducted in accordance with GMP, local, corporate, and relevant international regulations. Ensure quality standards are in use, manage issues, and foster a culture of continuous improvement and compliance.
- Support inspection readiness efforts. Perform quality oversight on analytical activities within both GMP and non-GMP environments in the Boston area, creating partnerships to implement and maintain fit-for-purpose quality standards.
- Monitor and manage stakeholder relationships with business units, liaising with early PQL and other quality partners to ensure project quality strategies align with regulations.
- Lead or participate in initiatives to enhance quality culture, efficiency, partnership, and fit-for-purpose quality assurance.
- Liaise and work to build One voice QA through all the sites.
- Act as a compliance authority, providing fit-for-purpose quality oversight to ensure that all testing activities meet quality standards. Maintain overall quality standards from method development through to release testing by performing gemba walks, coaching, and reviewing critical documents. Accountable for overseeing Deviation, Corrective and Preventive Actions (CAPA), and Change Control processes.
- Perform operational quality oversight on laboratory operations and provide input to risk management and management monitoring.
- Provide quality oversight on R&D projects according to relevant and fit-for-purpose quality standards and represent Analytical Quality at the CMC board/Quality Subteam.
- Promote, influence, and contribute to quality initiatives to foster a quality culture and mindset. This includes harmonizing quality standards and simplifying processes while driving both compliance and efficiency. Ensure that quality practices are fit for purpose and aligned across all supported analytical departments within the Quality R&D Lab Analytical department.
- Proactively review and provide risk-proportioned quality input to processes and systems, including QA revision/approval of relevant written standards and controlled documents (e.g., SOPs, changes, reports, analytical methods).
- Participate in local and global QR&D Quality Projects, supporting R&D QMS implementation and continuous improvement initiatives.
- Prepare and support the R&D functions for audits conducted by GSK (L2/L3 audits) and/or external Health Authorities (L4 audits).
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s Degree in Pharmacy, Science, or an engineering discipline
- 10 years of Manufacturing/Quality experience in the Pharmaceutical industry
- 10 years in analytical, pharmaceutical industry and Quality experience.
- Experience of working with multi-functional teams.
Preferred Qualifications:
- Scientific background to understand the product characterization and manufacturing and link the CPP and CQA to the patient
- 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
- Analytical expertise
- Ability to manage networks and build relationships transversally across the Vaccines network.
- Flexible thinking and Risk based approach methodology adept.
- Excellent oral and written communication skills. Problem identification and solving skills.
- Strong interpersonal skills with an ability to enable and drive change.
- Ability to adapt, work under uncertainty and accommodate flexible work demands
- Global perspective
- Ability to withstand pressure, self-motivated.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.
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