Site Manager

Are you looking to accelerate quality improvement and enhance your compliance expertise by working in a state of the art manufacturing environment?  If so, this Third Party Quality Manager role could be an exciting opportunity to explore.

As a Third-Party Quality Manager, you will be responsible for supporting and coordinating any compliance initiatives within the Contract Manufacturing Organization (CMO) to ensure compliance of Third Party Sourced products with the GSK Quality Management System and all relevant regulatory and legislative requirements.

Job Location: Daman, India – Req 407586

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.

We are looking for professionals with these required skills to achieve our goals:

• MSc Microbiology
• Manufacturing experience within a highly regulated environment
• Experience with Quality Assurance Systems and Clinical Good Manufacturing Practices (cGMPs)

If you have the following characteristics, it would be a plus:

• Advanced degree
• Familiarity with Quality Systems principles and practical application
• Demonstrated application of Quality and Risk Management principles and tools

Our values and expectations are 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:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

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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