Director, Quality Assurance

A brief overview Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see . What you will do Maintain and improve the company’s quality system per FDA ICH Q7 requirements for drug substances Manage, support and participate in regulatory inspections, manage customer Quality audits, serving as the point of contact and represent QA on project teams. Manage Quality Data Analytics and provide KPI data to QA Oversee and conduct GMP, ICH and ISO training to comply with regulatory requirements Manage Quality Management Review and APR Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records Oversee quality functions, including but not limited to deviations, CAPA, NCMR, annual product quality reviews, calibration program, DCR system, change control system, raw material release, QC record review, stability studies review, and batch record review Establish head count needs for the QA group and recruit, train and manage personnel to meet the business needs of the company Perform cGMP internal audits and cGMP surveillance across the BAM sites Resolve day to day issues within functional departments and provide compliance assistance as needed, ensuring continuos improvement and effectivenss of the quality managemnet system. Oversee work of direct reports; distribute workload, and cross train staff on different quality areas. Interview, hire, train, develop and manage employees. All responsibilities are to be performed in compliance with company policy as well as with applicable domestic and international regulatory requirements. Qualifications Bachelor's Degree in Science related field or Master's Degree or Ph.D. in Science related field (Preferred) 10+ years work experience in a Quality field for GMP company 5+ years management experience (Preferred) Knowledge of GMP, ISO, FDA, EU and international regulations Ability to direct, mentor and motivate others Excellent written and oral communication skills including data analytics Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to manage critical projects to deadlines as part of an interdisciplinary team Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Communicate effectively and ability to function well in a team environment Presentation skills, technical writing and editing skills Ability and willingness to work flexible/extended hours and moderate travel as needed to support the business Certifications: QPA, CQA,CQE (Preferred) Salary Range: $167,354.40-$230,112.30 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. At Bachem, you’ll find a diverse, multicultural team. The (a)in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. Please note: unsolicited resumes from recruitment agencies will not be considered. #J-18808-Ljbffr Bachem Holding AG