Shalina Healthcare - Head - Corporate Quality Assurance (15-20 yrs)

Role: Head - Head Corporate Quality (Global Supply Organization)

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's long-term goals. Partnering closely with the CTO and GSO 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.

Essential qualifications, experience and skills:

- M.Pharm / B.Pharm / Master's in science Preferred.

- 15+ years of leadership experience in quality assurance, preferably within the pharmaceutical or life sciences industry.

- Strong understanding of ROW regulatory landscapes 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.