Quality Manager

About the Role:

The Quality Manager is responsible for ensuring full compliance with quality, regulatory, and process improvement objectives. By maintaining a strong presence on the manufacturing floor, the Quality Manager oversees the development and implementation of management systems that prevent deviations and uphold product and process quality. This role ensures that packaging materials and research solutions consistently meet customer expectations and conform to all relevant cGMP and regulatory standards, supporting the company's pharmaceutical business growth goals.

Minimum Qualifications:

Bachelors' Degree in science or equivalent in pharmacy or related field. 7+ years in pharmaceutical or biotech manufacturing in Quality .Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines. Excellent oral and written communication is required to communicate with the team, peers, management and external contacts. Proficient with interpreting and implementing ISO, cGMPs, FDA standards and CFRs.Strong leadership to mentor and develop team to achieve Company goals.Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.

Preferred Qualifications:

• Certified Quality Engineer (CQE) or equivalent quality certification.
• Experience with lean manufacturing principles and value stream mapping.
• Demonstrated success in scrap reduction and cost-saving initiatives.
• Familiarity with advanced quality tools such as Six Sigma methodologies.
• Experience working in a multi-site or global manufacturing environment.

Responsibilities:

Develop departmental strategy and vision to ensure adherence with management and customer expectations.Direct quality department operations by being hands-on: monitor, review and improve systems and processes to ensure compliance with core quality measures.Provide support and guidance to ensure adherence to regulatory and legal requirements by analysing and improving quality systems and product quality assurance and controls. Oversee, motivate, mentor, and evaluate the Quality Department's employee performance, training and career development.Develop and train best laboratory practices to meet global pharma customer standards.Expand and improve the processes and systems to minimize complaints and nonconformities.Coordinate the review and update of SOPs, policies and processes regularly to ensure all quality standards are in compliance with global cGMP standards and all competent authority regulations and requirements, for supply of quality packaging material for pharmaceutical products. Oversee the analysis and review of the quality control tests, quality control documents, batch records and release of the conforming materials to ensure release in a timely manner. Lead investigations and analysis of quality complaints and implement corrective action and preventive plan to ensure its effectiveness.

Compensation details: 00 Yearly Salary

PI385b28b5-