This role is crafted for accomplished Quality professionals who bring a strong blend of technical expertise, regulatory understanding, and leadership capability to drive Quality Assurance excellence across highly regulated pharmaceutical environments. As a Senior Manager – Quality Assurance, you will take ownership of end-to-end quality strategy, ensuring that every aspect of product development, manufacturing, and distribution consistently aligns with global regulatory standards and internal quality benchmarks.

You will act as a key custodian of the organization’s Quality Management System (QMS), ensuring its robustness, effectiveness, and continuous improvement. This includes oversight of critical quality processes such as deviations, CAPA, change control, OOS/OOT investigations, and documentation practices, ensuring they are executed with precision, compliance, and audit readiness at all times.

Responsibilities

Lead end-to-end Quality Assurance operations across manufacturing and R&D environments, ensuring consistent adherence to defined quality standards and regulatory expectations

Ensure full compliance with cGMP, ICH guidelines, and global regulatory requirements across all processes, systems, and product lifecycle stages

Oversee and continuously strengthen the Quality Management System (QMS), including effective management of Deviations, CAPA, Change Control, and OOS/OOT investigations

Drive a state of continuous audit readiness, leading regulatory inspections and ensuring timely, effective responses and closure of observations

Establish and maintain robust documentation control frameworks, including SOPs, policies, and quality records, ensuring accuracy, traceability, and compliance

Collaborate with cross-functional stakeholders to implement quality risk management frameworks, ensuring proactive risk identification and compliance alignment

We’re Looking For

B.Pharm / M.Pharm / Life Sciences (advanced degree preferred)

10+ years of experience in Pharma Quality Assurance (regulated markets)

Strong exposure to regulatory audits and inspections

In-depth knowledge of cGMP, ICH, USFDA, EMA guidelines

Hands-on experience in QMS systems and compliance frameworks

Strong leadership, problem-solving, and stakeholder management skills