Interim QA Manager Ensures Seamless Oversight Across Multiple CDMO/CMO Sites
Overview
Arunava Ghosh was engaged by a leading biopharmaceutical company to temporarily fill the role of QA Manager during a period of absence within the Quality Assurance department. His assignment involved overseeing quality operations across multiple Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) handling Drug Substance (DS) production. His strong background in quality systems and regulatory compliance enabled him to immediately provide effective oversight and continuity in a complex, multi-site environment.
Objective
The primary objective of his assignment was to ensure robust QA site oversight during the absence of the permanent QA Manager. His responsibilities included managing quality-related changes, site Quality oversight on handling deviations, reviewing batch records, and supporting batch release activities across external manufacturing partners.
Key Challenges & Approach
The assignment posed several challenges due to the complexity of overseeing multiple CDMO/CMO partners, each with its own processes, timelines, and communication protocols. Arunava had to quickly adapt to the internal expectations of the sponsor organization while simultaneously establishing effective working relationships with external partners.
His approach was methodical and structured. He began by performing a rapid assessment of existing oversight processes, identifying any potential gaps or risks related to quality compliance.
Leveraging his experience, he prioritized high-impact activities such as deviation investigations, change control evaluations, and ensuring timely batch record reviews. By standardizing communication and reporting procedures across partners, Arunava improved clarity and accountability in QA operations.
Execution
Within the first weeks, Arunava integrated himself into the organization’s quality team and aligned closely with key stakeholders, including CMC, Regulatory Affairs, and External Manufacturing. He ensured continuous monitoring of CMO/CDMO activities, facilitated cross-functional discussions on open deviations, and took a proactive role in assessing the impact of quality events on product release timelines.
Arunava also worked on streamlining batch record review processes by introducing structured checklists and templates, which reduced review time without compromising compliance. He took part in review of Analytical method validation and transfer along with quality risk assessments and was instrumental in preparing quality documentation needed for internal and external audits.
Conclusion & Lessons Learned
His interim assignment highlights the critical role of experienced quality professionals in ensuring continuity and compliance within complex outsourced manufacturing networks. His proactive leadership, deep QA expertise, and ability to coordinate across diverse stakeholders ensured the biopharma company maintained high-quality standards and uninterrupted product release activities during a critical transition period. This case demonstrates the strategic value of interim QA leadership in maintaining operational excellence across global manufacturing partnerships.
Sr. Quality and Regulatory Compliance Consultant