With over 3,000 customer-centric employees, operations and commercial offices across the US, EU and China, Porton Pharma Solutions provides global pharmaceutical companies with innovative, reliable and end-to-end process R&D and manufacturing services across small molecule APIs, dosage forms and biologics.
Our Process Technology Centers and USFDA/EMA/PDMA/NMPA/WHO-inspected Manufacturing Facilities feature state-of-the-art equipment, highly flexible cGMP-compliant production assets, plus over 700 highly skilled scientists and process engineers, all backed by a proven program management system dedicated to seamlessly delivering successful outcomes for your unique project requirements.
We are committed to be the most open, innovative and reliable pharmaceutical service platform in the world and Enabling public’s early access to good medicines. We constantly strive for excellence, and have been recognized through awards by industry forums and global pharmaceutical companies for our process innovation, supply chain performance and compliance with global Quality and EHS standards. By efficiently advancing development and enabling commercialization of multiple high-impact medicines, Porton is proud to have earned the trust of some of the world’s leading and most innovative pharmaceutical companies and many biotechnology companies across the US, EU and Asia.
Drug Product CDMO：DDS.firstname.lastname@example.org
Gene&Cell Therapy CDMO：BD.SZ@portonbio.com
Job Type: Full-time
Job Location: Chongqing, CN
- Determine the plant’s overall quality policy & quality planning and quality manuals to compliance the company’s strategic plan, lead/oversee the quality system and quality culture established and continuous improved.
- According to business development requirements, establish the plant’s annual quality objectives, guide the establishment and review of key quality performance indicators of various systems to ensure that the quality system continues improved.
- According to business development requirements, establish the quality communication strategies with different types of customers to understand the quality needs and preferences of different customers, improve customer satisfaction, support business development.
- Oversee domestic and international registration affairs, preparation & submission updating & maintenance of registration documents, and coordination the related work of registration.
- Organize the internal quality audit arrangements for each system to ensure the effectiveness of the quality system.
- Guide and support the establishment and development of the quality teams, ensure adequate allocation of resources, build a learning team.
- Lead other related tasks of quality management system-related tasks.
- Bachelor or above degree in Chemistry/Pharmacy or related field required.
- More than 15 years’ experience in pharmaceutical industry, more than 5 years’ quality management experience at multinational pharmaceutical companies.
- Familiar with the domestic and FDA / EDQM and other major drug regulatory authorities’ requirements.
- Have a strong ability to analyze and solve problems, to be able to find a proper solution in multiple contradictions.
- Good organization and coordination & communication & decision-making skills.
- Good overall awareness.
- Good English listening, speaking, reading and writing skills.