Director Global Quality Compliance

TAPI; Mumbai; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

TAPI, based in Mumbai, invites a seasoned leader to head Global Quality Compliance across its API network. You will drive QMS, regulatory readiness, and continuous improvement across manufacturing sites and R&D centers worldwide.

You will partner with Quality, Manufacturing, Regulatory Affairs, and Supply Chain to strengthen quality culture, governance, and risk management, ensuring inspection readiness and regulatory excellence.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, or related field.
• Master's degree preferred in Science, MBA, or Pharmaceutical Sciences.
• 15+ years of progressive experience in Quality Assurance, Quality Systems, Compliance, or Regulatory functions.

Responsibilities

• Global Compliance Governance: implement and improve QMS, monitor quality metrics across sites.
• Inspection Readiness & Regulatory Excellence: lead inspection readiness and regulatory inspections.
• Quality Risk Management: drive risk-based quality management across the network.
• Quality Systems & Continuous Improvement: investigations, CAPA, and quality improvement plans.
• Audit & Compliance Oversight: oversee audits and closure of observations.
• Stakeholder Management & Leadership: collaborate across Quality, Manufacturing, Regulatory, Supply Chain & R&D.
• Capability Building: training on quality systems and regulatory compliance.
• Strategic Projects: lead global quality initiatives across sites.

Skills

Quality leadership

QMS implementation

Regulatory compliance

Inspections

CAPA

Data integrity

Risk management

Training

Education

Bachelor's in Pharmacy

Master's in Science / MBA

Regulatory certifications

Tools

Audit management systems

Data analytics tools

Job description

Company Description

Company DescriptionAt TAPI, were not just a companywere a community committed to advancing health from the core. As the worlds leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, were shaping the future of health worldwide. Our strength lies in our peoplea team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

Job DescriptionPurpose of the Job

We are seeking an experienced and strategic quality leader to lead Global Quality Compliance initiatives across our API manufacturing and R&D network. The role is responsible for ensuring a robust Quality Management System (QMS), regulatory compliance, inspection readiness, quality risk management, and continuous improvement across multiple manufacturing sites globally. The incumbent will partner with Site Quality, Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other cross-functional teams to strengthen quality culture, compliance governance, operational excellence, and regulatory preparedness while driving sustainable business performance.

Key Responsibilities

Global Compliance Governance

• Ensure effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS) across all manufacturing sites and R&D centers.
• Drive adherence to global quality policies, procedures, and regulatory requirements.
• Establish governance mechanisms to monitor compliance performance and quality metrics.

Inspection Readiness & Regulatory Excellence

• Lead and support site inspection readiness programs for global regulatory inspections and customer audits.
• Provide strategic guidance during inspections, including preparation, inspection management, response development, and post-inspection remediation activities.
• Review and support health authority and customer notifications related to quality and compliance matters.

Quality Risk Management

• Drive implementation of risk-based quality management practices across the network.
• Facilitate identification, assessment, mitigation, communication, and review of quality risks impacting product quality, compliance, and business continuity.
• Escalate critical compliance risks and provide recommendations for mitigation and corrective actions.

Quality Systems & Continuous Improvement

• Support complex investigations and ensure robust root cause analysis and CAPA effectiveness.
• Review site quality performance metrics and partner with site leadership to establish Quality Improvement Plans (QIPs).
• Lead initiatives focused on deviation reduction, data integrity enhancement, investigation excellence, and compliance transformation.

Audit & Compliance Oversight

• Oversee self-inspection programs, mock audits, and compliance assessments.
• Conduct quality walkthroughs and compliance reviews at manufacturing and laboratory facilities.
• Ensure effective closure of audit observations and regulatory commitments.

Stakeholder Management & Leadership

• Collaborate with Quality, Manufacturing, Regulatory Affairs, Supply Chain, and R&D leaders across the organization.
• Foster a culture of quality, compliance, and continuous improvement.
• Promote best-practice sharing and harmonization of quality processes across global sites.

Capability Building

• Deliver training and coaching on quality systems, investigations, risk management, inspection readiness, and regulatory compliance.
• Develop organizational capability through mentoring and knowledge-sharing programs.

Strategic Projects

• Lead and support global compliance projects aimed at improving product quality, patient safety, operational excellence, and regulatory compliance.
• Drive implementation of global quality initiatives across manufacturing sites.

QualificationsEducation & Experience

• Bachelors degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related scientific discipline.
• Masters degree in Science, Business Administration, Pharmaceutical Sciences, or related field preferred.
• Relevant professional certifications in Quality, Compliance, or Regulatory disciplines are desirable.
• 15+ years of progressive experience in Quality Assurance, Quality Systems, Compliance, or Regulatory functions within the pharmaceutical or API manufacturing industry.
• Strong leadership experience managing quality compliance programs in a global and matrix organization.
• Proven experience handling regulatory inspections from agencies such as USFDA, EMA, MHRA, TGA, PMDA, and other international health authorities.
• Expertise in Quality Risk Management, Investigations, CAPA, Data Integrity, and Inspection Readiness.
• Experience in API manufacturing environments is essential.
• Exposure to sterile manufacturing environments is an added advantage.
• Additional .