Associate Director, Quality Biologics Development

vor 6 Monaten

Schachen, Schweiz MSD Vollzeit

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The Global Development Quality Assurance group ensures every single material inside our clinical products are manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal clinical manufacturing facilities, external contract manufacturers and suppliers we are dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. We offer long-term career opportunities in a company which values innovation, efficiency, diversity and respect. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork

For our Swiss Clinical supply site, we are currently looking for an Associate Director, Quality Biologics Development is responsible for leading the Quality Biologics Development team in Schachen in support of the development programs for our portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of biologics supplies produced at our facility. Key requirements of the role also include ensuring the continued evolution of a quality culture across stakeholder groups via the development and implementation of effective and efficient compliance and business processes with a strong operational focus aligned with business drivers.

Ensure reliability of biologics products manufactured for our clinical trials via daily operational management for the biologics disposition and supporting activities, with the associated potential for high impact to the development portfolio, supporting 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 re; development of identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.

Coaching, mentoring, and developing team members supporting their personal development.

**Responsibilities**:

- Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives.
- Demonstrated leadership, incl. strategy development and deployment experience with tangible delivered benefits in a development environment.
- Demonstrated experience in quality risk management in the pharmaceutical industry.
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.
- Experienced and strong people manager with proven track record of developing talent.
- Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals and groups at all levels.
- Strong project management skills and experience; ability to conduct well defined projects on complex topics.

**Your Profile**:

- Bachelor’s Degree, Master’s degree or PhD in Biotechnology, Pharmaceutical manufacturing, biology or related field.
- Extensive relevant experience working within the pharmaceutical industry or advanced Degree with numerous years relevant experience, ideally related to manufacturing of biologic medicinal products.
- Experienced people manager.
- Experience interacting with regulatory official.

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 develo

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