Associate Director, Compliance and Quality Systems
Vor 2 Tagen
Our team is within our Research & Development Division's Quality Assurance, Global Development Quality organization and is responsible for oversight of manufacturing activities for the Clinical Supply Chain. Partnering across our internal facilities and external contract manufacturers 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. We are looking for strong leaders with an international and cross-functional mindset, strong stakeholder management skills, the ability to maintain and develop strong working relationships with network leaders and progress our systems and process development to the next level.
The Associate Director, Quality Systems and Compliance, plays a critical role leading the enabling functions within Quality in support of the Clinical Manufacturing Operations and Supply Chain. The key duties of the Quality Systems and Compliance team include systems management as documentation, SOP Management, Archiving, Data Integrity, Training, Quality Risk Management, Deviations Management, Change Management, Supplier Management, Clinical Development Quality management systems healthcare, and compliance such as Auditing, Internal audits management, Health Authority Inspection Management, and Complaints management. The team is also accountable for the Quality metrics. Additionally, the team drives innovation and digitalization of our processes thereby enabling speed and reliability for our systems. The team partners closely with the key stakeholder groups including Global Clinical Supplies, Development Quality, Analytical Development, Biotech Operations, and our IT team as well as multiple Quality Assurance sites and functions within the Global Quality Development.
**Primary Assignments**:
- Lead of Quality Systems and Compliance team to support site compliance
- and objective
- achievement (including support of individual staff members)
- Direct management responsibilities for assigned staff including:
- resourcing, setting and reviewing objectives, providing feedback and staff training & development
- Maintain and provide expertise in Quality Compliance and may act as System Owner (SO)
- Support the implementation of the QMS redesign as a local lead of Quality systems and Compliance
- Provide adequate training system and training strategy
- Ensure and drive permanent site inspection readiness through briefings, internal audit
- & walkthrough-program management and follow up
- Support and facilitation of inspections
- Preparation, review and approval of procedures related to core tasks
- Preparation, facilitation and approval of compliance measures
- Quality oversight for external partner on site
- Organization and facilitation of Site Quality Council (including provision of monthly metrics and follow up)
**Education**:
- Bachelor's Degree in Engineering, Biology, Chemistry or related field.
- A minimum of 8+ years of relevant experience within the pharmaceutical industry or 6+ years with advanced degrees.
**Preferred Experience and Skills**:
- Demonstrated leadership, including strategy development / deployment and background with tangible delivered benefits.
- Knowledge of continuous improvement and project management methodologies; ability to lead matrix teams and direct complex cross-functional initiatives, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.
- Demonstrated experience in quality risk management in the pharmaceutical industry.
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.
- Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/groups at all levels.
- Computer skills; knowledge and competency, Trackwise, PowerPoint, Excel and Word.
**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 (Weystrasse, 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 global clinical studies. The site is also home to one of our global forensic laboratories where we carefu
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