QC Director/Senior Director

Key Responsibilities

1. QC Laboratory Management

• Develop and implement quality control strategies to ensure QC laboratory operations comply with international regulatory requirements, including FDA, EMA, NMPA, PMDA, and other applicable regulations.

• Lead and organize QC laboratories in preparation for and participation in regulatory inspections, such as PAI inspections, GMP inspections, unannounced inspections, and customer audits.

• Ensure QC laboratory compliance in analytical method transfer, method verification, method validation, and routine testing operations.

• Lead and coordinate QC laboratories to establish unified quality standards and analytical methods for commercial products.

• Manage product quality-related quality events, including change controls, deviations, and OOS investigations.

• Collaborate with supply chain planning to support release testing for commercial and clinical products.

• Develop and oversee QC laboratory budgets, optimize resource allocation, and improve operational efficiency.

• Ensure robust operation of the QC laboratory system and drive continuous improvement.

• Ensure safe operation of QC laboratories, with no critical incidents or personal injuries.

• Lead continuous improvement initiatives across QC laboratories and promote the sharing and implementation of best practices.

• Represent the company in communications with industry associations and regulatory authorities to stay current with regulatory updates and industry trends.

• Collaborate with cross-functional teams to support company projects.

• Complete other tasks assigned by supervisors.

2. Performance Management and People Development

• Set QC laboratory objectives and ensure company strategies and goals are clearly understood, effectively executed, and successfully achieved.

• Lead problem-solving initiatives and establish standardized workflows to improve performance management.

• Set clear goals for QC team members, guide them in achieving objectives, and support and motivate their career development.

• Ensure the efficient and effective operation of the QC team.

Job Requirements

• Bachelor’s degree or above in Pharmacy or a related field.

• At least 15 years of practical experience in quality management within the pharmaceutical industry, including hands-on experience in quality control.

• Strong ability to make sound judgments and effectively address issues arising in quality management.

• In-depth understanding of pharmaceutical regulations in major global markets, especially QC-related regulatory requirements, such as FDA, EMA, ICH, NMPA, and others.

• Extensive experience in global QC compliance audits, including direct experience with regulatory inspections.

• Strong knowledge of QC laboratory compliance requirements, including method validation, data integrity, and laboratory controls.

• Excellent risk assessment and risk management capabilities, with the ability to identify potential compliance risks and develop effective mitigation strategies.

• Outstanding communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders at all levels.

• Strong analytical thinking and problem-solving skills, capable of managing complex compliance issues.

• Proven ability to collaborate effectively across departments and functions.

• Proficiency in both English and Chinese.

• Proficient in Microsoft Office applications, including Windows, Word, and Excel.