Senior Quality & Compliance Manager in Manufacturing (a), 100%

Senior Quality & Compliance Manager in Manufacturing (a), 100% # Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With a comprehensive range of services, Bachem offers products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. Headquartered in Switzerland with locations in Europe, the USA, and Asia, Bachem operates internationally and possesses more than 50 years of experience and industry-unique expertise. The company is listed on the SIX Swiss Exchange. Further information at: www.bachem.com To drive our continuous organic growth, we are constantly looking for highly qualified specialists. To strengthen our team in Manufacturing Coordination, we are looking for a dedicated Senior Quality & Compliance Manager in Manufacturing (a), 100%. You will play a central role in processing more complex Quality & Compliance topics and, in this responsible role, will report directly to the Senior Director Manufacturing Coordination. Your tasks: • Conducting complex investigations in operations following Quality Events in Manufacturing • Assembling and leading interdisciplinary ad-hoc teams following Quality Events in Manufacturing with the aim of identifying the cause as quickly as possible, documenting it, and defining further action • Ensuring a prompt resumption of production after Quality Events in compliance with all compliance requirements • Effective internal and external stakeholder alignment in coordination with QA, the Business Development project team, and other stakeholders depending on the case • Formulation of the associated Deviation Records together with QA and the affected organizational units • Deriving effective, also cross-departmental, CAPAs in coordination with the affected organizational units • Ensuring adherence to deadlines when processing all Quality Events in the Manufacturing area • Creation of Quality Metric Dashboards for the attention of the division management and presentation of Quality topics at team meetings • Continuous improvement of the quality culture in Manufacturing in accordance with cGMP guidelines and company requirements. • Representing the division in customer audits and inspections by health authorities (e.g., Swissmedic, FDA, etc.) including preparation and follow-up • Leading / controlling strategic projects within your own area as well as active participation in cross-departmental initiatives Your profile: • Master in natural sciences (chemistry, pharmacy, chemical engineering) with a doctorate • At least 7 years of professional experience in a relevant industry (pharmaceutical industry/ C(D)MO in the field of Drug Substance manufacturing is an advantage), including several years with QA responsibility for your own area/department • At least 5 years of experience in the functional leadership of interdisciplinary teams in complex environments with multiple interfaces • At least 5 years of experience in project management, in leading interdisciplinary project teams, and in dealing with customers, authorities, and internal stakeholders • Experience in creating concepts for compliance with current GMP regulations, with a focus on cGMP rules for active ingredients in CH, EU, and USA • Good knowledge in the field of analytical methods and organic synthetic chemistry (peptide production and analysis is an advantage) • Appreciative, inspiring leadership style; role model for teamwork; bridge builder • Strong communication and presentation skills, decision-making competence • Business acumen with a view for the big picture as well as for the relevant detail • Experience in change management • Business fluent English and German skills, both written and spoken Our offer: • A dynamic and strongly growing work environment with internal development and further training opportunities • Flexible working hours with the possibility of home office and the option to take additional vacation days with a reduced workload • In-house KITA on the Bachem Campus Bubendorf • 60% coverage of pension fund contributions by Bachem AG as well as the possibility for supra-mandatory provision with our optional savings plan • Access to benefit platforms with discounts at external partners • Diverse free sports activities on the Bachem Campus Would you like to drive innovations forward together with us? Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal. Learn more about the Bachem Group and be inspired by our inspiring work environment at our location in Bubendorf! At Bachem, you will find a diverse, multicultural team. (a) in the job title stands for everyone. We look forward to applications from all people. Skills and motivation count - completely independent of age or gender, origin, religion, or sexual orientation. *Note: Applications from recruitment agencies will not be considered.* Forward job advertisement via email