Senior Specialist QA (m/f/d)

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 Senior 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.

Responsibilities

• Act as Quality representative for in-house or outsourced manufacturing programs (clinical phase I – III). Duties include compliance oversight of program related activities, review and approval of batch records, complex deviations and out of specification events, change controls, and certificates of analysis.
• Review and approval of Master Batch Records, Bill of Materials and Recipes as part of campaign preparation activities.
• Support and propose Corrective and Preventive Actions (CAPA) as needed.
• Independently review and approve production and analytical documentation accompanying the disposition of Raw Materials, Cell Banks, or Drug Substance lots to ensure conformance to appropriate regulatory requirements.
• Participate and direct quality-on-the-floor initiative.
• Ensure that SOPs are periodically updated to reflect departmental procedures. Ensure that SOPs comply with applicable regulations.
• Maintain a proficient level of knowledge related to specialized area of technical expertise (such as analytical method / development) or GMP requirements and industry trends as described in applicable worldwide regulations.
• Provide guidance to functional areas on requirements for all assigned project tasks related to quality and our standards. Ensure that quality requirements are understood and managed by all stakeholders throughout the product life cycle.
• Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.
• Support global harmonization initiatives.
• Support preparations for regulatory agency inspections. May accompany regulatory agency officials, conducting inspections of facilities or operations in supported areas, including GMP Certification inspection. Support proactively the resolution of audit findings.
• 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.
• 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.
• Demonstrated proficient 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.
• Ability to quickly recognize problems and develop solutions. Open to constant development and changes in the clinical environment as well as changing priorities.

Your Profile

• Bachelor’s Degree in pharmacy, biotech engineering, Biology, Chemistry or related field.
• Extensive experience 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.
• 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.

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’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 Schachen site is crucial for the development and supply of innovative medicines. With over 400 employees, we focus on producing and testing new biological medicines. From Schachen, we export new drugs for global clinical trials, ensuring their safety and efficacy. Additionally, our site investigates suspected cases of drug counterfeiting, operating as one of only three such laboratories worldwide.

Who We Are …

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 …

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

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

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Requisition ID R275847