Site Manager- External Supply Expert

3 weeks ago

Dehra Dūn, Uttarakhand, India ScaleneWorks Full time

**Job Title:** Site Manager- External Supply Expert

**About ScaleneWorks:** ScaleneWorks is a leading company in the industry, and we are seeking an experienced Site Manager- External Supply Expert to join our team. This role will be responsible for managing external supply chains and ensuring compliance with regulatory requirements.

About the Role:

As a Site Manager- External Supply Expert, you will oversee the implementation of quality management systems (QMS) at contract manufacturing sites. Your primary responsibilities will include:

1. Regulatory Compliance:
- Implement and monitor QMS requirements at contract manufacturing sites.
- Conduct QMS and Environmental Health and Safety (EHS) gap analysis and mitigation.
- Ensure all-time Good Manufacturing Practices (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.

2. 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 Contract Manufacturing Organizations (CMOs) and coordinate necessary remediation.

3. Product Lifecycle Management (PLM):
- Review and approve Product tech transfer documents.
- Drive Tech Transfer, Process validations, and Continued Process Verification.

4. Training and Development:
- Conduct GMP trainings at site, Complete assigned training within due dates. Follow development plans and track progress with line managers.

5. EHS and Statutory Compliance:
- Ensure EHS and statutory audit compliance at CMOs.
- Close agreed Corrective Action Preventive Actions (CAPAs) within timelines.

6. 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.

What We Are Looking For:

We are looking for an experienced Site Manager- External Supply Expert who has a strong understanding of cGMP and QMS. The ideal candidate will have a post-graduation degree with 6+ years of experience in Quality Assurance, preferably in the pharmaceutical or biotechnology industry. A strong knowledge of aseptic manufacturing guidance and sterile dosage forms is required. Additionally, excellent regulatory compliance and audit readiness skills, effective issue resolution and decision-making capabilities, and strong communication and documentation skills are essential. The ability to work collaboratively with cross-functional teams is also required.

**Estimated Salary:** $85,000 - $110,000 per year, depending on experience and qualifications.

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