Pharm'Up 
Abbott, a global healthcare leader, is seeking an experienced professional for the role of Senior Manager – Third Party Manufacturing (TPM) Quality Assurance. This position is critical for overseeing product and site compliance across assigned TPM sites, ensuring that all Abbott-branded products meet the highest quality and regulatory standards.
Position Overview
| Feature | Details |
| Post Name | Senior Manager TPM QA |
| Location | Mumbai, Maharashtra |
| Industry | Pharma / Healthcare |
| Functional Area | Quality Assurance |
| Application Deadline | March 30, 2026 |
Key Responsibilities
- TPM Oversight: Lead the oversight of assigned TPM sites to ensure site and product compliance with Abbott policies and GMP standards.
- Audit Readiness: Guide teams through site visits to maintain constant audit readiness and ensure Quality Agreements are active.
- Compliance & Investigations: Ensure Pharmacopoeial compliance and lead investigations into market complaints, OOS (Out of Specification), and OOT (Out of Trend) failures within stipulated SLAs.
- Technology Transfer: Oversee Technical Transfers at TPM sites, including analytical method transfers and First Lot Quality Review (FLQR).
- Quality Metrics: Assess site performance periodically using quality metrics and manage the implementation and closure of CAPA (Corrective and Preventive Actions).
- Stakeholder Management: Coordinate with Regulatory Affairs, MS&T, Commercial, and Planning departments to manage quality expectations and navigate regulatory changes.
- Risk Management: Prepare risk assessments for critical audit observations and develop robust mitigation plans.
Candidate Profile
Education
- B.Pharm / M.Pharm / M.Sc. (Masters in Science).
- Additional certifications in Quality Management are an asset.
Experience & Skills
- Overall Experience: Approximately 20 years of extensive experience in QC/QA, QMS, R&D QA, TPM Management, and Tech Transfer.
- Regulatory Knowledge: Proficiency in regulations for global markets, including LATAM, APAC, and EU, is mandatory.
- Leadership: Proven track record in recruiting, mentoring, and developing high-performance quality teams.
- Technical Expertise: Strong background in dossier reviews, due diligence of sites, and handling large volumes of confidential quality data.
Position Accountability
As the key quality contact for South Zone sites, you will be accountable for establishing Quality Technical Agreements and ensuring divisional simplification and standardization in TPM QA processes.
How to Apply
Interested candidates whose profiles align with the senior-level requirements of TPM management and international regulatory compliance should apply through Abbott’s official career portal.
- Industry Type: Pharmaceutical / Clinical Research
- Required Language: Proficiency in English (additional languages are a plus).
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