Head Global Quality

Role: Head Global Quality

Base location: Navi Mumbai, India

What you become a part of:

The Head of Corporate Quality will lead the development and execution of quality assurance strategies aligned with the company&aposs long-term goals. Partnering closely with the Chief Technical Officer (CTO) and the Leadership Team, this role ensures robust quality management systems, regulatory compliance, and continuous improvement in operational performance.

What to expect:

• Establish best-in-class quality goals, perform quality metrics trending, apply problem solving, system improvements to meet these target levels of quality.
• Lead and manage the quality teams with oversight in operations at all manufacturing facilities with a continuous improvement focus.
• Team Building. Establish, inspire, train, mentor and manage a team of QA professionals in the adoption of new processes and tools.
• Collaborates with business units to develop quality targets for new and existing products.
• Manage quality projects/activities resulting from site consolidations, acquisitions.

• Collaborate with Quality Management System group on simplification, harmonization of quality systems and implementation across Operating Companies.
• Manages and maintains effectiveness of Quality System across all Shalina manufacturing sites and Contract Manufacturing site.
• Implementation and follow effective Vendor / Supplier development process.
• Maintains compliance to Global Quality Management System
• Drives recruitment activity and assures the ongoing professional development of direct reports and the overall company quality organization.
• Establishes standards/metrics to facilitate exponential growth while adhering to quality standards and regulatory guidelines.
• Participate and contribute to regular functional meetings (Supply Chain, Operational Excellence, and Sourcing, R&D)
• Responsible for QA teams in a group of global sites. The QA teams are responsible for Audit management, Document control, Deviation, Change Control, CAPAs, Complaints, Adverse event reporting, final product release, and other QA related activities.
• Promotes customer centric, proactively seeking ways to improve customer satisfaction.
• Use CAPA system to systematically improve processes and organization capabilities.
• Makes sure that sites are prepared of Regulatory Agency Inspections. (Pre-Approval Inspections / Mock inspections and Training).
• Quality lead in the due diligence, transition, and integration in an acquisition project.
• Participates in the planning, review and approval of GMP /GDP related issues of new or remodeled facility layouts, including validation activities.
• Providing and participating in trainings efforts of Shalina sites on need basis
• Advice and support alliance partners/service providers/central distribution center to ensure compliance to Quality requirements.
• Gives immediate support in the form of possible corrective actions during the audit and Compliance.

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Essential qualifications, experience and skills:

• M.Pharm / B.Pharm / Master&aposs in Science preferred.
• 15+ years of leadership experience in Quality Assurance, preferably within the pharmaceutical or life sciences industry.
• Strong understanding of Regulatory landscapes in semi-regulated markets, and international quality standards.
• Exceptional commercial acumen and strategic business insight.
• Excellent consulting and communication skills (oral, written, interpersonal, presentation) with the ability to influence senior stakeholders.
• Strong personal credibility and interpersonal skills with the ability to build trusted relationships with senior business leaders and teams alike.
• High level of integrity and dependability with a strong sense of urgency and results-orientation
• Experience working cross-culturally and cross-functionally with diverse colleagues.