CSL Behring
Director Combination Products – Primary Packaging and Medical Devices (PPMD)
This job is now closed
Job Description
- Req#: jP2Y5D-0b0y3QpsQBQ5h6w
- Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Device and/or Combination products including 21CFR Part 4, Part 820, ISO 13485, ISO14971 and device ISO/AAMI standards.
- Broad medical device /combination device technical knowledge of current industry trends
- Proven ability to develop strategies and lead improvement projects.
- Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of continuous improvement.
- Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.
- PhD or other advanced degree in areas such as Engineering, Natural Sciences, or other relevant area.
- At least 10 years of related experience in medical device or combination product development/support in the pharmaceutical industry.
- Set and drive best practices within PPMD for combination product development.
- Create and maintain standard operating procedures, work instructions, and templates for PPMD to use in the development of combination products.
- Ensure compliance with current and emerging global device/ combination products legislation. Will require interaction with critical partner groups such as Combination Product Quality, Regulatory Affairs, and multidisciplinary, multi-site groups, which may include technology transfer teams, external vendors, and other strategic suppliers.
- Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs.
- Establish productive collaborations between R&D, Operations, and the third-party suppliers to progress development projects.
- Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
- Lead combination product/ device engineers and scientists to effectively handle commercial biological/drug-device combination product development.
- Drive the development of combination products, accessories, and ancillaries as required by the business.
- Identify and develop talent to meet PPMD business requirements. Plus develop robust succession plans that provide career opportunities for individuals while and supporting business resiliency.
Job Description
This role is a leadership position in the Primary Packaging and Medical Devices (PPMD) department within CSL R&D.
Qualifications
Responsibilities
About Us
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!
About the company
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies. CSL is the parent company of CSL Behring.
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