Shanghai, CHN
60 days ago
Head of R&D Quality-Animal Health
**About Animal Health Business** As the leading animal health company in China, we have extensive business coverage from the full value chain in R&D, production to sales and a diversified product portfolio covering swine, poultry, pets, cattle vaccines and medicines. We are always "in China and for China". We've pioneered many game-changers in the veterinary medicine, and we're looking to our customers' needs to guide us into the future. **Job Responsibilities:** 1. Quality Strategy Roadmap: -Drive the Overall Strategy for GI Quality China regarding Quality projects, New Product Development, and Technology Transfers. -Align with Global Innovation and Global Supply Chain needs and requirements with the global quality strategy. -Serve as the primary interface with Regulatory Affairs and associated Regulatory Agencies. -Be member of the local site leadership team. 2. Quality Assurance in CMC: -Manage a function which will ensure/execute all quality and compliance matters are under control during transfer (analytical and tech). -Provide technical-regulatory expertise for production/analytical transfer. -Ensure Quality of all Chemistry, Manufacturing and Controls processess and products. 3. Supervise Quality Management System: -Represent quality function in respective subteams, monitor and report status, QA work packages and escalate QC/QA issues. 4. Audits & Inspections: -Prepare for and accompany internal and external audits as well as inspections by regulatory authorities. -Conduct supplier audits to ensure quality of raw materials and services. -Collaborate with Global Supply Chain Quality to ensure compliance to regulatory requirements in alignment with global QA strategies. 4. Leadership role to Global Innovation QA and Global Innovation: -Support the GIQA leadship team (Regional Quality Head, Global Clinical and Global Development) to define strategic goals of the GI functions. -Function platform including smooth QA team work, build up network, define Quality team priorities, input budget forcast and ensure team adhere to budget during the year -People Management, develop staff and build a talent pipeline for the Quality organization at the site (using performance review, Talent development, Career Mapping). -Coach, encourage, mentor, and develop local GIQA and GI team members by fostering the right mindset and behaviours. -Develop and conduct training programs for employees on GMP and CMC quality. -Contribute to harmonization and improvement of global GIQA processes. -Drive the Continuous Improvements using advanced data management techniques and quality methods / tools including appropriate metrics to monitor progress. Promote innovation, best practices and system performance. **Job Requirements:** 1. Educational Requirement: Doctoral Degree (e.g. PhD, MD) or Masters degree (e.g. MBA, MSc) or Bachelor Degree with major focus on Biotechnology, Microbiology or equivalent education and experience. 2. Minimum 5-10 years of professional experience in vaccine research and development. 3. Profound knowledge of manufacturing processes, sterile and aseptic. 4. Furthermore, experience in biopharmaceutical process steps as upstream, downstream formulation, analytical methods and validation are preferred. 5. Preferably in Quality within a Pharmaceutical Company working under GMP regulations. 6. Good knowledge of regulations especially China regulatory requirements(CVP). 7. Experience to provide functional leadership and to work in a multicultural environment, combined with a record to develop people. Experience to implement strategic goals as well as to work in a matrix organization. 8. Project management and excellent communication skills 9. Proficiency in both English and Chinese: read (fluent), write (fluent), speak (fluent). 10. International exposure in daily business (>50% of international business/customers/staff). 11. Required Capabilities: -Strong leadership skills with the ability to get the buy-in of multiple stakeholders including: Inspiring, Coaching, Empowering, project/time management -Strong interpersonal-relationship skills (resource planning, conflict management, open-mindness, networking), collaboration and negotiation skills. Managerial attitude and be able to lead and inspire a team. -Ability to make clear decisions, appropriately balancing risks versus consequences -Strong experience with regulatory inspections and regulations as well as GxP requirements as applied to the site. -Ability to work under pressure, cope with multiple priorities and deal with ambiguity -Proactive and motivated with a clear passion to drive change and make significant improvements. -Ability to work in a team and matrix environment and network across the company as well as to position the group as a pragmatic and reliable partner for GI. -Ability to manage multiple interfaces in a complex environment. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Confirm your E-mail: Send Email
All Jobs from Boehringer Ingelheim