Associate Director, Clinical Supplies Quality
vor 1 Woche
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
The Associate Director, Clinical Supplies Quality, Global Development Quality is responsible for managing Clinical Supplies disposition activities in support of the clinical development programs for the company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies manufactured at our facilities and or our External Partners.
This position reports to the Director, Clinical Supplies Quality and will have responsibility for operational management, capacity planning and scheduling for clinical finished goods and supporting activities as well as ensuring operational processes and systems are managed and enhanced.
This position will require an in-depth close collaboration with local and global key stakeholder groups as well as multiple Global Development Quality sites and functions that support the clinical supply chain. This position will also include navigating dynamic, high impact and high visibility situations on a regular basis in relation to ensuring that our company's clinical development portfolio and pipeline is not disrupted due to issues with clinical supplies.
**Responsibilities**:
- Ensure reliability of clinical supplies availability for our company's clinical trials via daily operational management for the clinical finished goods disposition and related activities, with the associated potential for high impact to the development portfolio.
- Assure capacity planning, scheduling and operational processes and systems are managed and enhanced for clinical supplies disposition and associated activities.
- Support the development and execution of quality strategies, improvement initiatives in line with business drivers and objectives to ensure and enhance the robustness of our compliance posture whilst streamlining processes and procedures.
- Provision of in-depth technical and quality expertise including identification of trends and or potential compliance gaps and proactively leading the resolution of significant issues affecting quality in areas of expertise.
- Coaching, mentoring and developing team members supporting their personal development and also creating a high performing team.
- Assist, as part of the Clinical Supplies Quality Leadership Team, the development of strategic plans and translates and defines these in terms of related work processes and practices.
**Education**:
- Bachelor’s Degree in a Scientific Discipline.
**Required Experience and Skills**:
- Extensive experience within the pharmaceutical industry.
- Demonstrated people management or leadership experience.
**Preferred Experience and Skills**:
- Experienced and strong people manager with proven track record of developing talent.
- Demonstrated leadership including strategy development and deployment experience with tangible delivered benefits.
- Demonstrated operational management experience, including capacity planning and scheduling.
- Demonstrated knowledge of continuous improvement methodologies; ability to manage complex cross-functional initiatives.
- Fluent in English and preferably German but not essential.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
**THE COMPANY**
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for gl
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