Quality by Design Lead (m/f/d), CoE Product Robustness & Data Science
Quality by Design Lead (m/f/d), CoE Product Robustness & Data Science
Quality by Design Lead (m/f/d), CoE Product Robustness & Data Science
Quality by Design Lead (m/f/d), CoE Product Robustness & Data Science
Ferring Pharmaceuticals, Inc.
Pharma, Medizintechnik
Kiel
- Art der Anstellung: Vollzeit
- 71.000 € – 110.000 € (von XING geschätzt)
- Vor Ort
Quality by Design Lead (m/f/d), CoE Product Robustness & Data Science
Über diesen Job
Job Description
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas so that we can bring science to life for patients around the world.
Our Technical Operations division develops, manufactures and supplies high-quality products so our patients can live better lives. Creating and delivering life-changing products means getting it right first time is a shared responsibility, so our global manufacturing teams work closely together to ensure quality, accuracy and safety at all times. That means a culture of empowerment, where speaking up is valued, and growth and development are constant.
Ferring+You
The Quality by Design (QbD) lead (m/f/d) is positioned in the Center of Expertise (CoE) Product Robustness & Data Science and part of the Global MTS (Manufacturing Technology and Sciences) in Global Technical Operations.
You will play a pivotal role in driving business achievements through Quality by Design (QbD) design and management. This role involves leading QbD governance and roadmap across the network and products, working with site and R&D experts. Also you will collaborate with data scientist and AI experts to accelerate deployment of QbD leveraging large databases and with process robustness leads to improve process control and improvement strategy. Finally QbD is pivotal in all product transfers and launches hence you will interact with TechOps and R&D project teams globally.
QbD drives continuous improvement and process robustness. Ferring aims to use QbD as a foundations for product and process robustness program, to ensure we collect all relevant data to build golden batch & digital twins. QbD outcomes comprise updating technical standards, building capability and process understanding and uplifting the culture to be more data and risk driven.
Your day at Ferring
- Develop and lead a QbD roadmap
- Lead QbD governance with relevant stakeholders; animate the QbD community of practitioners
- Lead cross-functional QbD project acting as a recognized QbD facilitator
- Manage QbD resources pool (consultancy pool)
- Drive QbD program continuous improvement, ensuring with Site QA head the consolidation of risk assessment and support to investigation and process performance.
- Establish and keep updated standards for QbD (eg templates, handbooks, decision matrix, AI tools, QbD dashboard…)
- Build & maintain a "state of the art” data product knowledge
- Create, maintain, expand and continuously update scientific and regulatory knowledge on product & process risk
- Travel expectation: 20% (China, Danmark, US, Switzerland) with upfront planning.
Behind our innovation...There's you
- Degree in Pharmaceutical Science, Biotechnology or Biotech Engineering, Chemistry, or equivalent.
- Minimum 7 years of experience in pharmaceutical or biotech industry, of which at least 3 years in a supporting function role within one or more of the following areas: Biologicals/biotechnology, Aseptic manufacturing technologies, Pharmaceutical production, Quality Assurance
- Strong knowledge and experience in QbD methodologies, statistics, and risk management
- Expertise in manufacturing process & optimization
- Expertise in Lean: Strong knowhow of lean tools applying performance standards to QbD
- Excellent problem-solving skills and ability to think critically
- Strong communication & facilitation skills: Effectively collaborate with cross-functional teams and facilitator mindset.
- Activator & action oriented.
- Excellent command of English and preferably another European language.
People come first at Ferring
- Get inspired from our commitment to advocate for everyone's right to build a family, no matter who you are, where you live or who you love
- Our inclusive support package – "Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role. Available to all employees after the first year of employment.
- Parental leave for both birthing and non-birthing parents
- Extended support on family building journey
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member's contributions. Imagine the power of your career when it's Ferring + You.
Behind our purpose...There's you
If our mission and your vision are aligned, please apply!
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.
We are looking forward to your application!
Equal Opportunities
Ferring is proud to be an equal opportunity employer. We are committed to providing all potential employees with equal access to employment opportunities throughout the recruitment process. Ferring complies with and supports all national and local laws regarding anti-discrimination.
Ferring is proud to be an equal opportunity employer. We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status. Ferring complies with and supports all national and local laws regarding anti-discrimination.
Data Processing
All data will be treated in accordance with the Group's compliance policies. Further information can be found in the Recruiting Privacy Policy.
All data is handled in accordance with the Group's compliance guidelines. Further information can be found in the Recruiting - Privacy Policy.
Information for recruitment agencies
Ferring International Center SA and all affiliated companies do not accept candidate proposals from unsolicited third parties. Candidates submitted by unsolicited third parties (such as recruitment agencies, headhunters, etc.) will not be included in the recruitment process and will not be further considered. Furthermore, such a submission does not create a contractual relationship between Ferring and any third party. Ferring is neither obligated nor willing to pay any fee to third parties who submit candidates in this way.
Ferring International Center SA as well as all affiliated companies do not accept candidate proposals from unsolicited third parties. Candidates submitted by unsolicited third parties (such as recruitment agencies, headhunters, etc.) will not be included in the recruitment process and will not be considered further. Furthermore, no contractual relationship between Ferring and a third party shall arise from such a submission. Ferring is neither obliged nor willing to pay a fee to third parties who submit candidates in this way.
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