TAPI
Website:
tapi.com
Job details:
Company Description
At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s 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, we’re shaping the future of health worldwide.
Our strength lies in our people—a 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 Description
Purpose 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.
Qualifications
Education & Experience
- Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related scientific discipline.
- Master’s 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 Information
Make Your Mark with TAPI
Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!
Click on Apply to know more.
