Site Quality Head  Job Purpose :  The incumbent is accountable for products of right quality released to market, timely support to supply chain to provide right quality products at right time, ensure total compliance with local drug and related regulatory requirements and monitor site compliance to GSK Group Quality Policies and Guidelines and provide support for the same.  Key Responsibilities :  - Serves as a member of the site leadership team, working actively on Strategy deployment to support GSK Objectives. Takes a leading role in developing and implementing Quality and Compliance strategies and initiatives. Ensures full deployment of GSK's Quality Management System (QMS), ensuring requirements are both in place and in use. Develop, monitor, foster stepwise continuous improvement of key quality metrics. Ensures appropriate Quality metrics are deployed effectively throughout the site and uses metrics to drive improvement.  - Ensures GSK Values for Customer First, Respect for people, Transparency and Integrity are prioritized for decision making at the site. Leads talent development / talent management activities for Quality staff.  - Leads site risk management process and ensure good root cause and mitigation strategies are in place. Ensures appropriate governance and escalation processes are in use.   - Manages complex change programs across multi-faceted issues (e.g. people, products, etc.)  - Hosts regulatory agency inspections and assures site inspection readiness. Ensures effective regulatory conformance and compliance programs are established.  - Direct all Quality related functions for the manufacturing facility including validation and approval authority for the release of product to commercial while providing expertise in critical quality areas, such as chemistry, microbiology, manufacturing, packaging, and regulatory and validation. Assists in identifying, developing and implementing new technologies and facility-wide process improvements.  - Holds cross-functional responsibilities ranging from participation on product development teams through commercial launch for new products and lifecycle issues for on-going commercial products.   - Ensures GSK records retention policy is in place and in use for site Quality records as well as complying with CIA requirements as a Manufacturing Covered Person.  - Accountable for adequate Corrective and Preventive Action development arising from any critical or major audit findings and monitoring progress on a quarterly basis, at a minimum.  - Ensures that Site Safety is championed as part of Leadership team, setting high standards for Safety, confronting risks, ensuring that all staff proactively engage in safety conversations and ensuring facility is maintained to the highest standard with safety work orders getting priority focus based on criticality  Area of Specialization :  - Quality Control, Quality Assurance, Regulatory, Compliance Management, Audit Management, Quality Management Systems, Validation, Analytical, etc.  Job related experience :  - Must have good working knowledge of validation techniques and philosophy, as well as strong analytical, numerical and reasoning skills.  - Excellent technical writing skills, verbal communication skills, and presentation skills.  - Strong leadership skills, participative management style.  - Experience in auditing internal and external sites/suppliers; negotiation and facilitation of corrective actions  - Project management skills, ability to prioritize multiple top projects.  - Ability to analyze data, effectively summarize findings and draw conclusions; excellent problem solving skills.  - Extensive knowledge of cGMPs, FDA (or pertinent regulatory) guidelines, compliance requirements, facility registration, validation, labeling, regulatory submissions, annual reviews, regulatory reporting requirements and recalls.  - Working knowledge of Chemistry and method validation, Microbiology, Pharmaceutical Packaging, Pharmaceutical Validation, Change Control, Pharmaceutical dosage forms, Stability, Statistics/SPC, Regulatory.  - Basic knowledge in manufacturing operations, manufacturing equipment, formulation development, GSK Finance systems, Dashboard Measures, Operational Excellence, and 3/1 Planning process.  - Familiar with Total Quality Management, Team Based environments, and Management by Objective

Bangalore

GlaxoSmithKline - Site Quality Head 

GlaxoSmithKline - Site Quality Head  ,Job Description for GlaxoSmithKline - Site Quality Head  in GlaxoSmithKline Pharmaceuticals Limited in  Bangalore for (14-20) years of experience. Apply Now!

Job Description for GlaxoSmithKline - Site Quality Head  in GlaxoSmithKline Pharmaceuticals Limited in  Bangalore for (14-20) years of experience. Apply Now!