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

To drive our continuous organic growth, we are constantly seeking highly qualified professionals. To strengthen our team in Manufacturing Coordination, we are looking for a committed Senior Quality & Compliance Manager in Manufacturing (a), 100%. You will play a central role in handling more complex Quality & Compliance issues and report directly to the Senior Director Manufacturing Coordination in this responsible position.

Your responsibilities:

• Conducting complex investigations in operations following Quality Events in Manufacturing
• Assembling and leading interdisciplinary ad-hoc teams after Quality Events in Manufacturing with the aim of identifying the cause as quickly as possible, documenting it, and defining the further course of action
• Ensuring prompt resumption of production after Quality Events while complying with all compliance requirements
• Effective internal and external stakeholder alignment in coordination with QA, the Business Development project team, and other stakeholders as applicable
• Formulating the associated Deviation Records together with QA and the affected organisational units
• Deriving targeted, including cross-departmental, CAPAs in coordination with the affected organisational units
• Ensuring adherence to deadlines in handling all Quality Events in the Manufacturing area
• Creating Quality Metric Dashboards for the management and presenting quality topics at team meetings
• Continuous improvement of the quality culture in Manufacturing in accordance with cGMP guidelines and company requirements.
• Representing the department in customer audits and health authority inspections (e.g. Swissmedic, FDA, etc.) including preparation and follow-up
• Leading/managing strategic projects within the department as well as actively participating in cross-departmental initiatives

Your profile:

• Master’s degree 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 advantageous), including several years with QA responsibility for own area/department
• At least 5 years of experience in functional leadership of interdisciplinary teams in complex environments with multiple interfaces
• At least 5 years of experience in project management, leading interdisciplinary project teams, and dealing with customers, authorities, and internal stakeholders
• Experience in developing concepts to comply with current GMP regulations, focusing on cGMP rules for active ingredients in CH, EU, and USA
• Good knowledge in analytical methods and organic synthetic chemistry (peptide manufacturing and analytics advantageous)
• Appreciative, inspiring leadership style; role model for teamwork; bridge builder
• Strong communication and presentation skills, decision-making competence
• Business acumen with an eye for the big picture as well as relevant detail
• Experience in change management
• Fluent English and German skills, both written and spoken

Our offer:

• A dynamic and rapidly growing work environment with internal development and training opportunities
• Flexible working hours with the possibility of home office and option to take additional holidays with reduced working hours
• Company daycare centre on the Bachem Campus Bubendorf
• 60% coverage of pension fund contributions by Bachem AG as well as the possibility for supplementary pension provision with our savings plan
• Access to benefit platforms with discounts from external partners
• Various free sports activities on the Bachem Campus

Would you like to drive innovation forward with us?

Have we piqued 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 working environment at our location in Bubendorf!