Site Manager- External Supply

Job Description: Site Manager - External Supply India

Job Location: Dehradun, India – Req 407394

Position Overview: To provide Manufacturing and Quality leadership at contract manufacturing sites to ensure that products are manufactured and supplied with adherence to current Good Manufacturing Practices (cGMP) and GSK Quality Management System (QMS).

Key Responsibilities:

QMS and Regulatory Compliance:

• Implement and monitor GSK QMS requirements at contract manufacturing sites.
• Conduct QMS and EHS gap analysis and mitigation.
• Ensure all-time GMP audit readiness and follow up on audit compliance.
• Ensure Quality events/ quality-related issues are managed timely and in a compliant way to ensure timely product release.
• Support contract sites in continuous quality improvement.
• Ensure compliance with regulatory requirements to avoid supply disruptions and punitive actions.
• Review and Maintain Quality Agreement, product specifications, artwork, Product Performance Reviews (PPR), Batch records, analytical records, Stability study documents and other GMP documents at site.
• Review and monitor Product Performance Reviews (PPR) for all products.
• Ensure audit readiness and compliance with audit findings.
• Implement CAPA arise out of different QMS events.

Manufacturing support and Product Release

• Track and support timely release and delivery of raw material, packing materials and finished products by resolving quality-related issues.
• Assist contract sites in improving their contribution to business performance management.
• Resolve product supply issues promptly.
• Provide daily batch-wise tracker status and GEMBA reports to stakeholders.
• Ensure timely communication of Quality Alerts to CMOs and coordinate necessary remediation.

Product Lifecycle Management (PLM):

• Review and approve Product tech transfer documents.
• Drive Tech Transfer, Process validations and Continued Process Verification.

Training and Development:

• Conduct GMP trainings at site, Complete assigned training within due dates. Follow development plans and track progress with line managers.

EHS and Statutory Compliance:

• Ensure Environmental Health and Safety (EHS) and statutory audit compliance at CMOs.
• Close agreed CAPAs within timelines.

Business and Project Support:

• Participate in Business Review Meetings (BRM) with CMOs.
• Escalate outstanding issues to the ES Quality Operation Lead.
• Contribute to quality improvement projects and cost reduction initiatives.

Key Competencies:

• Post graduation with 10+ years of experience in Quality Assurance, Preferably  work experience in Injectables.
• Well versed with Aseptic manufacturing Guidance and knowledge on sterile dosage forms.
• Knowledge on Microbiological tests.
• Strong understanding of cGMP and QMS.
• Excellent regulatory compliance and audit readiness skills.
• Effective issue resolution and decision-making capabilities.
• Strong communication and documentation skills.
• Ability to work collaboratively with cross-functional teams.

Note: This job description outlines the primary duties and responsibilities of the position but is not exhaustive. Additional tasks may be assigned as necessary.

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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