The Associate Director, Quality Biologics Operations is responsible for leading the Biologics Quality organization 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 / 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.
Primary skills include but are not limited to:
- Strong technical expertise in R&D activities specifically related to manufacture of biologics, coupled with the ability to interact with and influence stakeholder subject matter experts and senior leaders on various initiatives and issues
- Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment
- 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/ groups at all levels
- Strong project management skills and experience; ability to conduct well defined projects on complex topics
- Bachelor’s Degree in engineering, Biology, Chemistry or related field.
- A minimum of 5+ years of relevant experience working within the pharmaceutical industry or advanced Degree with 3+ years relevant experience, ideally related to manufacturing of biologic medicinal products.
- Experience interacting with regulatory officials
Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.