Head – TPM Quality Assurance (Biosimilars) – India
Location: Mumbai, India
Category: Quality
Platform: ThePharmaDaily.com Global Job Portal
The Head – TPMQA (Biosimilars) will oversee Quality Assurance activities for Third-Party Manufacturers (TPMs) supporting the Biosimilars portfolio across India and the APAC region. This leadership role ensures full compliance with GMP standards, Abbott quality policies and regulatory requirements, while maintaining rigorous oversight of TPM performance and product quality.
Quality Oversight and Compliance
Lead and manage quality operations and GMP compliance across all TPM sites aligned with EPD Biosimilars Operations in India.
Oversee QMS implementation and continuous improvement at TPM facilities.
Ensure TPMs maintain inspection readiness for Abbott audits and regulatory inspections.
Review and approve Annual Product Quality Reviews (APQRs).
Drive adherence to Abbott policies, procedures and global quality frameworks.
Operational Quality Leadership
Monitor, evaluate and report TPM performance ratings.
Implement Abbott’s quality strategy across TPMs, ensuring consistent application of standards.
Lead quality improvement projects and initiatives at selected TPM sites.
Ensure compliance with regulatory and quality requirements related to labeling, documentation, stability studies and product release.
Develop quality strategies to support Biosimilar supply chain operations across TPM sites in the region.
Promote QMS visibility and adoption across TPMs and guide teams on its effective execution.
Quality Culture and Continuous Improvement
Foster a strong quality-focused culture through targeted training and awareness programs.
Establish processes to manage and close customer complaints within defined timelines, ensuring thorough investigations.
Conduct periodic quality review meetings with TPM QA teams to monitor performance and identify improvement areas.
Documentation and Regulatory Alignment
Review and approve quality documents including change controls, deviations, FLQR and exception reports.
Ensure product supply meets regulatory filing requirements for relevant Abbott markets.
Verify that products are released only after approved changes and full compliance validation.
Identify TPM training needs and support capability development for Biosimilars operations.
Ensure timely closure of product complaints with robust investigations.
Maintain full compliance to regulatory expectations, Abbott standards and market requirements.
Support TPMs in delivering high-quality Biosimilar products on a consistent and sustainable basis.
Education
M.Pharm, M.Sc in Biochemistry, Microbiology or equivalent scientific discipline.
Experience
Minimum 12 years of experience in Quality Assurance.
Experience in the Quality function within a Biosimilar manufacturing environment is strongly preferred.
Proven expertise in TPM Quality Management and GMP compliance.
Strong understanding of Biosimilar product requirements, regulatory expectations and QMS implementation.
Ability to lead cross-functional quality initiatives across multiple external manufacturing sites.
Strong analytical, communication and decision-making capabilities within complex supply chain environments.
This listing has been expertly enhanced for SEO, GEO relevance and GPT optimization to ensure maximum visibility on ThePharmaDaily.com for highly qualified global talent in the Biosimilars Quality domain.
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