Job Title: Quality Director
Location: Taiwan (Relocation Available)
Company Overview: We are a leading pharmaceutical company dedicated to improving the health and well-being of patients worldwide. With a commitment to excellence and innovation, we strive to deliver high-quality pharmaceutical products to meet the evolving needs of our customers and patients.
Position Overview: We are seeking a highly skilled and experienced Quality Director to join our manufacturing site in Taiwan. The Quality Director will play a key role in ensuring that our manufacturing operations meet the highest quality standards and regulatory requirements. This individual will lead a team of quality professionals and work closely with cross-functional teams to drive continuous improvement initiatives and uphold our commitment to quality excellence.
Key Responsibilities:
- Develop and implement quality strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards.
- Lead and mentor a team of quality professionals, providing guidance and support to ensure effective execution of quality initiatives.
- Oversee the quality management system, including document control, training, deviation management, change control, and CAPA processes.
- Conduct risk assessments and develop risk mitigation strategies to prevent quality issues and ensure product safety and efficacy.
- Collaborate with cross-functional teams, including Manufacturing, R&D, Regulatory Affairs, and Supply Chain, to drive quality improvement initiatives and resolve quality-related issues.
- Ensure timely and accurate completion of quality-related documentation, including batch records, validation protocols, and regulatory submissions.
- Lead internal and external quality audits and inspections, ensuring compliance with regulatory requirements and driving corrective actions as needed.
- Stay abreast of industry trends and regulatory developments, proactively identifying opportunities for process improvement and risk mitigation.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biochemistry, or related field; advanced degree preferred.
- Minimum of 8 years of experience in quality assurance or quality control within the pharmaceutical industry, with at least 3 years in a leadership role.
- In-depth knowledge of cGMP regulations, ICH guidelines, and other relevant regulatory requirements.
- Strong leadership and team-building skills, with a proven track record of effectively leading and developing high-performing teams.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and influence stakeholders at all levels of the organization.
- Demonstrated ability to drive continuous improvement and implement best practices to enhance quality systems and processes.
- Experience with regulatory inspections and audits, including FDA, EMA, and TFDA inspections, is highly desirable.
- Fluency in English and Mandarin Chinese is required.
Apply now with your CV and relevant candidates will recieve a call back from one of our consultats to discuss further.
