QA Manager

At Elanco (NYSE: ELAN) – it all starts with animals

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today

Position Description (岗位描述)：

To lead the Chengdu site quality assurance to ensure quality activities comply with the Elanco EGQS and official requirements from competent authorities.

To provide appropriate training and support to enable the production activities to a high standard of quality.

Functions, Duties, Tasks（职能、职责、任务）:

To ensure that all of changes including routine and project changes are fulfilled in compliance with local laws and regulations, Elanco EGQS regulations.

To organize and follow up self-inspection and external inspection from competent authorities. To prepare and evaluate audit report, follow up CAPAs implementation and input in Veeva on time.

Establish QAAs and purchase specifications, perform periodical review of QAA.

Qualify the suppliers to ensure providing the materials persistently met with specification. Guarantee the production efficiency and high quality of products.

To conduct supplier management to control supplier changes, update qualification documents in time, evaluate supplier performance and handle supplier complaints and quality issues triggered by internal complaints, deviation, OOS, etc. to proactively with ownership until these issues are resolved, evaluate suppliers investigation report and CAPAs. Give training to suppliers periodically to enhance their GMP mindset.

Ensure BOM is always in the latest version and material number is defined scientific and reasonable.

Ensure regulatory compliance to communicate and align with RA as support RA's jobs, such as product license renewal, etc.

Responsible for product technology transfer in Quality function to prepare related documents for products transfer. Responsible for supporting new product development.

Responsible for total validation management, deviation management, ensure quality activities comply with Elanco EGQS.

In case of quality events, responsible for submitting NTM in time, it is needed to follow Elanco NMT process.

Ensure product, RM & PM be released on time.

Ensure PQR complete on time and follow up remediation in PQRs.

Minimum Qualification 最低资格:

At least 8 years of pharmaceutical manufacturing, with at least 3 years in total quality management.

2-3 years of team management experience.

Good English in written and spoken.

Bachelor or above degree in Pharmacy, Biology, Chemistry, Biotechnology, etc.

Experience for validation management, change management, supplier management, product release and regulatory affairs is preferred.

Know about manufacturing process and laboratory control of GMP products.

Preferably familiar with related Chinese laws and regulations of veterinary product and feed/feed additive product.

Strong leadership, ownership and team spirit