\\nJob Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we \\xe2\\x80\\x9cfollow the science\\xe2\\x80\\x9d 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 \\xe2\\x80\\x93 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:

• Strong technical expertise in Research and Development 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; Good Manufacturing Practices to a Research and Development 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 and groups at all levels.
• Strong project management skills and experience; ability to conduct well defined projects on complex topics.

Your Profile:

• Bachelor\\xe2\\x80\\x99s Degree, Master\\xe2\\x80\\x99s 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 development and commercialization of many of our company\\xe2\\x80\\x99s 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 \\xe2\\x80\\x9cTop Employer Switzerland\\xe2\\x80\\x9d and \\xe2\\x80\\x9cTop Employer Europe\\xe2\\x80\\x9d showing the company\\xe2\\x80\\x99s 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 carefully monitor our products through the supply chain to ensure security and safety for our patients.

Who we are \\xe2\\x80\\xa6

We are known as Merck & Co., Inc., Rahway, 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 \\xe2\\x80\\xa6

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\\xe2\\x80\\x94and start making your impact today.

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\\xe2\\x80\\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Specified

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): No\\n \\n \\n \\n \\n \\n

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