Job Description

The Plant Lead Quality will oversee the Quality Assurance (QA) and Quality Control (QC) functions, ensuring compliance with global regulatory standards, continuous process improvement, and effective SAP integration. The role is critical to maintaining high-quality manufacturing standards and supporting the facilitys global operational goals.
Key Responsibilities
1. Quality Assurance Leadership
Develop, implement, and maintain QA policies and procedures to ensure compliance with pharmaceutical regulations, industry standards, and internal requirements.
Lead and mentor QA/QC teams to foster effective quality management practices.
Monitor key quality metrics and implement corrective and preventive actions to resolve issues and drive continuous improvement.
2. SAP Implementation and Optimization
Lead the implementation, configuration, and optimization of SAP Quality Management (QM) modules.
Collaborate with IT and SAP consultants to ensure SAP solutions align with QA requirements and regulatory compliance.
Train and support QA and production teams on SAP QM functionalities and best practices.
3. Audit Management
Prepare for, conduct, and oversee internal and external audits, including regulatory inspections and certifications.
Resolve audit findings and implement corrective actions.
Keep up-to-date with audit requirements and industry standards.
4. Regulatory Compliance
Ensure QA processes comply with GMP, FDA, EMA, and other relevant regulations.
Monitor changes in regulations and update QA processes accordingly.
Coordinate submissions and communications with regulatory bodies.
5. Continuous Improvement
Identify and lead initiatives to enhance QA processes, efficiency, and product quality.
Implement best practices and continuous improvement methodologies within QA.
Analyze quality data and trends to support data-driven decision-making.
6. Documentation and Reporting
Oversee creation, maintenance, and review of QA documentation including SOPs, validation protocols, and quality reports.
Ensure timely and accurate reporting of quality performance to senior management.
7. Supplier and Vendor Management
Evaluate and monitor quality of materials and components from suppliers.
Collaborate with suppliers to resolve quality issues and improve supply chain standards.
Candidate Specification
Education
Bachelors degree in Pharmaceutical Sciences, Chemistry, Biology, or related field.
Advanced degree or professional certification (CQE, Six Sigma) is a plus.
Experience
Minimum 10 years in pharmaceutical QA within a manufacturing environment.
Proven experience with SAP Quality Management (QM) implementation and optimization.
Extensive experience managing internal and external audits, including global regulatory inspections (EMA, USFDA, MHRA).
Expertise in quality control techniques, sampling, inspection, and testing.
In-depth knowledge of cGMP, ICH, WHO, EMA, USFDA, and MHRA guidelines.
Experience with Quality Management Systems, Risk Management, Data Integrity, and Industry 4.0 applications in QA/QMS.
Skills & Competencies
Strong leadership, communication, and interpersonal skills.
Excellent analytical, problem-solving, and decision-making abilities.
Proficiency in SAP QM and related modules.
Ability to drive continuous improvement in complex QA processes.
Strategic thinking with a results-driven mindset.

Skills Required