Head of QC - Biopharma at Boehringer… · Shanghai

About Biopharmaceutical Contract Manufacturing

Boehringer Ingelheim aims to become China's first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China's biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China's innovative medicines in a bid to accelerate growth of China's bio-technology industry. The Company's state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.

Job Responsibilities:

As the Head of Quality Control for China Biopharmaceutical Business, lead and manage the strategic, operational performance and budget management of the Quality Control at Biopharma Shanghai, ensuring the successful delivery of business strategy, QC relevant KPIs, whilst adhering to regulatory GMP compliance.

• Develop and implement the QC strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the QC performance against goals.

• Successfully transfer QC methods from analytical development to BI Biopharma Shanghai QC, State -of-the-art qualification and (re)-validation of analytical methods required for DS, DP, raw material, excipients and packaging materials testing.

• Review and approve certificate of analysis, test protocols and stability studies of biopharmaceutical drug substances and drug products according to global BI standards and in line with local Chinese as well as relevant international GMP standards.

• Ensure successful and efficient management of projects within Biopharma China accordingly to defined project plans and timelines (time/capacities/Cost).

• Support analytical and quality control strategies for successful clinical trail authorizations in China, in line with SFDA requirements.

• Leading the Quality Control Organization considering BI's leadership principles. Identification, hiring and development of Quality staff according to BI's talent management principles.

Job Requirements: -More than 10 years of relevant experience if QC in pharmaceutical industry. At least 3 years experience in leading QC organization with strong scientific, regulatory and compliance background is a prerequisite.

• A good background in biological analytical testing specially in protein and Microbiological, as well as expertise in analytical method validation and method transfer. An excellent knowledge of GMP, ICH, USP and global compendia regulations and GMP guidance's, particularly as related to quality control.

• Have been engaged in sterile products quality management. Thorough understanding of applicable laws, regulations, and regulatory requirements related to pharmaceutical quality management is required.

• Strong leadership and the ability to motivate employees, forms strong and diverse teams of people with multiple perspectives and talents.

• Strategic thinking, business orientation, strong communication and negotiation skills, and fast decision-making abilities.

-Good command of both oral and written English and Chinese.