Associate Director, Quality Assurance
vor 7 Stunden
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 Associate Director, Quality Operations reports to the Associate Director, Quality Assurance Operation Schachen Biologics and supports clinical quality activities at the company Werthenstein site. They are accountability for Good Manufacturing Practice compliance, ensuring clinical supply functions operate within Good Manufacturing Practice requirements and compliant clinical drug substance and drug product supply. The Associate Director, Quality Operations will drive or support compliance-based programs and results which include supporting and leading cross functional projects, solving complex problems, current Good Manufacturing Practices quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedures management, and site procedures.
**Responsibilities**:
- Provide guidance, consulting, interpretation of Good Manufacturing Practice and regulatory requirements or standards.
- Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory at all levels.
- Review and approval of relevant master batch records, Bill of Materials and recipes.
- Review and approval of process risk assessments as appropriate.
- Participate and direct quality-on-the-floor initiative.
- Support drug product manufacturing operations.
- Ensure deviations are investigated and resolved. Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
- Support, review and approve as needed the change management program.
- Provide guidance and support on equipment qualification, Software Development Life Cycle, raw material release activities, environmental monitoring, as well as support of utilities functions.
- Perform Standard Operating Procedures review and approval within Quality and for functional area procedures.
- Participate in the release or rejection of Good Manufacturing Practice materials and components either through direct batch release support or involvement with critical program issues.
- Conduct all work meeting high standards for quantity, integrity, quality, and Good Manufacturing Practice compliance.
**Your Profile**:
- A Master’s Degree in Engineering, Sciences or related field and extensive experience in the pharmaceutical, biotech or another regulated industry.
- Technical writing experience, including investigations, laboratory reports, standard operating procedures, batch records, or protocols.
- Ability to conduct multiple investigations within established deadlines.
- Demonstrated ability to manage multiple projects and initiatives.
- Experience with formal problem-solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and Lean Six Sigma tools.
- Current Good Manufacturing Practice experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
- Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
- Experience and in-depth knowledge of fully integrated, automated and recipe driven operation.
- Experience in drug product filling and inspection practices.
- Fluent in English and German.
**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 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 **
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States an
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