349399BR
Jul 21, 2022
China

Job Description

26000+! That’s how many employees at Sandoz worldwide. We are a division of the Novartis Group and a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to high-quality and affordable medicine worldwide. Join us and pioneer access for more patients!

Your responsibilities include, but are not limited to:
• Lead, coordinate and support a global QA project team (including TRD and exter-nal partner), and represent TRD QA globally in TRD sub-teams, as well as at global quality board meetings and management reviews/development gate meetings. Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise.
• Act as quality contact for assigned projects and contributes to the strategy of these projects incl. contingency planning and risk management as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy fol-lowed within the assigned projects is in line with TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
• Understand and proactively manage the interactions of project related activities between TRD QA and all internal and external partners. Provide guidance and quality expertise on the quality systems of internal & external partners in accordance with pharmaceutical/ISO regulations, good pharmaceutical practices and Novartis standards.
• Prepare, support and in alignment with audit team perform inspections and audits as required and provide support to line functions in GMP compliance. Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation.
• Provide input to contracts and QAA with internal and external partners. Approve project-specific QAA amendments for assigned projects. Support the Quality Risk Management through proactive risk management tools and approaches, to minimize impact on development deliverables, supplies and patients.
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
• Represent TRD QA in Due Diligence teams and provide quality assessment of po-tential in-licensing products in a timely manner and support follow-up activities as appropriate.
• Lead or participate in global and/or cross-functional initiatives. Coach and mentor functional experts. Participate in recruiting process.

Diversity & Inclusion / EEO

诺华致力于打造一个卓越、包容的工作环境和多元化团队,代表我们服务的患者和社区。

Minimum Requirements

What you’ll bring to the role:

• Education minimum: Advanced degree in science or relevant discipline. education desirable: Ph.D. in science of relevant discipline.
• Fluent English required (oral & written). Good skills in site (local) language.
• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control.
• Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (IND, IMPD, BLA, NDA, ANDA, MAA).
• Broad experience (minimum 8 years) in technical drug development as well as in Quality Assurance and/or Quality Control departments. Experience in Technical Operations or equivalent experience from external company is preferred.
• Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function.
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
• Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Group network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.
SANDOZ
BioPharma SZ
China
北京
全职
正式员工
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349399BR

TRD Quality Project Lead

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