Senior Quality Assurance Manager

Senior Quality Assurance Manager (Taiwan)

We are looking for an Senior Quality Assurance Manager in the Pharmaceutical manufacturing Industry to ensure that all products and services meet all quality requirements, including compliance with customer and regulatory standards for safety and reliability. This role is critical in developing and implementing robust quality programs for the manufacturing site.

Job Responsibilities

 Develop, implement, and maintain comprehensive quality programs that adheres to company and regulatory standards of pharmaceutical production from in-coming raw materials to out-going finished goods

• Proactively build strong relationships with customers to address and resolve quality-related issues and promote continuous improvement
• Demonstrates a working expertise when identifying complex quality issues, what the issues impact, who they impact, and determine best practices for improving processes within the organisation and ensure accurate implementation of these processes
• Ensure cGMP compliance and systems and procedures deployed are in compliance with regulatory requirements
• Monitor and Maintain Quality Management Systems ensuring internal controls and improvement by reviewing and establishing quality standards, policies, and procedures for all departments involved in the manufacturing plant
• Facilitate inter-departmental partnerships to maintain high-quality standards for the manufacturing site and ensure alignment with HQ
• Oversee recruitment, training, and performance evaluation processes for the quality department, providing support and direction to team members.
• Ensure compliance with regulations such as US FDA and EU standards through internal and external audits.
• Lead site inspections, addressing issues and interacting with regulatory officials as needed.
• Manage the overall budget for Quality Operations and actively participate in the development and interpretation of Quality Policies and Procedures.
• Lead Quality Projects and initiatives across the organization

Job Requirements

• Possess a Bachelor’s degree in engineering, operations, or a similar field.
• At least 10 years of experience in Quality Assurance with 3 years in aseptic manfacturing
• Proven leadership in helming Quality department and driving quality standards in a manufacturing site
• Strong familiarity with GMP regulations, principles, and industry practices in aseptic production and operations
• Excellent interpersonal, problem-solving, risk analysis, and negotiation skills.
• Detail-oriented with strong written and verbal communication skills in English.
• Proficient in Mandarin only (i.e. proficiency in written Chinese language is not a must)
• Willingness to be based in Taiwan

Reg: R1104641 | Agency licence: 06C4985