Lead Operational Quality Assurance (m/w/d) New Assets

YOUR CONTRIBUTION

Join our global quality operations team and grow with exciting challenges. With your passion and expertise and together with our international colleagues, you will contribute to achieving our company goals. As an Operational Quality Assurance Lead, your responsibilities will include the following tasks:

• Lead and develop operational QA for New Assets
• Organize, monitor, and enhance the deviation system, process deviations in Jira and ensure timely resolution
• Oversee and improve the CAPA system, manage CAPA processes in Jira and ensure timely completion
• Manage and maintain training administration for Therapeutics Operations and handle document management in Smartsolve
• Develop product documentation for process, transport, and method validation and transfers for New Assets
• Create PQRs for New Assets
• Represent the area and activities during inspections by authorities and customers
• Act as Subject Matter Expert for deviations, CAPAs, and training management
• Serve as the contact person for internal and external stakeholders/customers

YOUR PROFILE

• Completed scientific Studies in Pharmacy, Chemistry or a related field of studies, PhD is an advantage
• Minimum 3 years of experience in the pharmaceutical industry
• Several years of proven leadership experience, ideally within Quality Assurance
• Good knowledge of cGMP (EU, FDA), GDP and change control processes
• Proficiency in Microsoft Office package and database queries as well as electronic QM and SOP systems
• Knowledge of national and international requirements for pharmaceuticals and medical devices
• Analytical thinking and the ability to understand complex matters
• Teamoriented, proactive organizational talent
• Strong communication and problem-solving skills with a confident appearance
• Excellent verbal and written communication skills in German and English

YOUR BENEFITS

• Individual career development in a purposeful job: you improve the quality of life of our patients!
• Hybrid work model that allows a good work-life balance
• Attractive location with good transport links, modern workplaces and a company restaurant
• Global family business with flat hierarchies and an open, respectful corporate culture
• Attractive remuneration with extensive social benefits
• Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike

Find out more about our benefits here.