Specialist Quality Assurance

Job Description

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 Specialist, Biologics Development Quality is responsible for 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 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.

• Quality Assurance (QA) support of in-house manufacturing programs (clinical phase I - III). The role will include compliance monitoring of manufacturing related activities on site, prepare and perform QA review of batch release documents including batch record review (paper and eBR), act as QA approver for change controls, deviations and Corrective and Preventive Actions (CAPAs), and support Quality Control (QC) related activities as needed.

• Support campaign readiness by releasing starting materials and incoming goods.

• Participate and support quality-on-the-floor initiative.

• Assist in the creation and maintenance of QA policies, Standard Operating Procedures (SOP’s) and reports in line with site/global requirements.

• Maintain a proficient level of knowledge related to specialized area of technical expertise.

• Participate and support risk management activities in line with relevant guidance and best industry practice.

• Work collaboratively to foster strong relationships with management and colleagues to drive a safe and compliant culture in our Research & Development facility.

• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Ability to quickly recognize problems and develop solutions. Open to constant development and changes in the clinical environment as well as changing priorities.

• Strong compliance knowledge and understanding of regulatory agency regulations and requirements. Participate and support onsite inspections by regulatory authorities. Support in the resolution of audit findings.

• 3 years’ experience in pharmaceutical industry in a QA function.

• Strong background in Current Good Manufacturing Practice (cGMP), risk management, investigations, problem solving.

• Strong written and verbal communication skills.

• Ability to think logically and be proactive under pressure.

• Ability to work as part of a team and on own initiative in a constructive manner.

• Strong attention to detail and precision in preparing and reviewing GMP documentation.

• Experience interacting with regulatory officials would be a plus.

• Experience in quality management systems such as Veeva, SAP, PAS-X etc. would be a plus.

• Experience in the clinical field would be a plus.

• Fluent English both written and oral along with a proficiency in German.

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.

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 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.

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 carefully monitor our products through the supply chain to ensure security and safety for our patients.

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.

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—and 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’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

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: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 03/25/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R338891