Position Summary
You will lead extractables and leachables (EL) quality activities across GSK s network in India. You will provide scientific EL guidance, perform toxicological assessments, and partner with cross-functional teams. You will ensure compliance with regulatory expectations and GSK quality standards. We value clear thinkers who communicate well, act with integrity, and want to grow while helping bring safe, reliable medicines to patients. This role offers learning, impact, and a chance to work at the intersection of science, technology and talent to get ahead of disease together. Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
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The job owner has a role of Quality Oversight of EL documents supporting Large Molecules, Small Molecules and Vaccines divisions including related CMOs.
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The job owner executes quality oversight review and approval of EL risk assessments, Patient Exposure Scenario (PES) Doc, internal or external (third-party) protocols and reports, any technical documents linked to the EL topic and all associated rationale/mitigation proposed.
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The job owner will work with external laboratories for outsourced EL protocols and reports (review and approval)
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The job owner is responsible for ensuring adequate application of GMP and GDP practices including respect of the ALCOA+ principles and the review of the traceability and accuracy of data and rationale proposed.
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The job owner has the task to ensure compliance with internal standards (GQP, GQSOP, GG etc.) and supportive document related to EL strategy in support of EL Global Subject Matter Experts.
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The job owner support EL Senior Global Quality Technical Leader to ensure appropriate and prompt risks escalation to the different parts of GSK.
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The job owner has to ensure that documentation is aligned with the ALCOA+ principle and that data integrity is supported by adequate rationale and evidence.
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The job owner has to support local quality representative to promote autonomy and performance in EL practices.
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The job owner has to support the expert community and participate in internal networks related to EL.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
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Minimum: Advanced degree in chemistry, biology, chemical engineering or similar field of study
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Preferred: Masters degree in Biochemistry, Chemical Engineering, or Bioengineering
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Experience: at least 10-16 years of experience in pharmaceutical or biopharmaceutical Quality or a related field. A working experience of at least 3+ years in the field of EL validation is required.
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Strong technical and quality skills in EL to support the review as for example Leachable Risk Assessment, Laboratory testing.
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Collaborative mindset and ability to work across functions.
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Resilience and adaptability in a dynamic environment.
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Knowledge of relevant regulations and industry standards (GMP, WHO, PDA, EU, ICH, ASTM, ISPE, USP etc.).
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Multicultural mindset skills
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Teamwork ability skills
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Prioritization skills
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Execution coordination skills in validation
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Working knowledge of Microsoft Excel, including the use of formulas, filters, and basic data structuring for Risk Assessment templates, along with general proficiency in Word and PowerPoint for documentation and presentations, is required.
Preferred Qualification
If you have the following characteristics, it would be a plus:
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Advanced degree (MSc or PhD) in toxicology, chemistry, pharmacy or related field.
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5+ years experience specifically focused on extractables and leachable or related toxicology roles.
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Experience using additional in silico tools or databases (OECD Toolbox, Helium, ToxPlanet, SciFinder or similar).
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Experience supporting regulatory submissions and audits related to EL topics.
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Experience working with contract research organizations or external laboratories.
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Comfortable working in a multicultural, matrixed organisation and mentoring junior colleagues.
