Quality Assurance, Internal Compliance

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: Provide and apply sound GMP based critical thinking in support of the Quality mission at Siegfried Irvine with particular focus on supplier qualification and site internal compliance. Your Profile: Responsibilities 1.Administration of the site Supplier Qualification Program, including but not limited to management of qualification status, initiation and tracking of annual qualification schedule, execution of qualification activities, and management of physical and electronic qualification records. 2.Monitoring of internal compliance, including but not limited to administration and execution of the Internal Audit Program, management of external standards library, and reporting of conformance to compliance targets. 3.Supporting the preparation and hosting efforts of customer, corporate, and regulatory audits including document and SME preparation.. 4.Assist site Regulatory Affairs expert with customer requests regarding regulatory submissions. 5.Assist and support in the Quality assessment, review, and/or approval of other QAD and Compliance areas of responsibility such as change control (including document changes), investigations, training administration, and logbook management. 6.Provide training, guidance, and sound GMP advisement to other team members and departments as needed 7.Any and all other duties as assigned by immediate supervisor. Required Knowledge, Skills and Abilities Auditing with high level understanding of GMP and applicable regulations (e.g., ISO, EU) at an academic, technical, tactical, and conceptual level Good oral and written communication skills Technical and formal/business writing Required Education and Experience Bachelor’s Degree in a scientific field or equivalent combination of education and experience 7 years' experience in the pharmaceutical, medical device, or biotech industry 4 years in experience in a Quality role High computer literacy with particular focus on Windows platform and Office applications (Word, Excel, PowerPoint); experience with eQMS such as TrackWise or MasterControl is a plus Strong organizational abilities 7 years' experience in the pharmaceutical, medical device, or biotech industry 4 years in experience in a Quality role Target Range: $75,000-90,000 Your Benefits: Medical, Dental, Vision Flexible Spending & HSA Options Life Insurance, Short & Long Term Disability Voluntary Life, Accident, Critical & Hospital Pet Insurance 401K Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry. Application Submission & Screening: Share your qualifications and enthusiasm through our application process. We review each submission to identify candidates whose skills best match the role. Initial Interview: We’ll explore your background, aspirations, and how you could contribute to our mission and culture. On-Site Interview: If possible, we invite you to meet us in person, connect with future colleagues, and get a feel for our workspace. Offer Stage: Congrats! If selected, you'll receive a detailed offer including compensation, benefits, and the exciting opportunities ahead. Onboarding: After you accept, we’ll guide you through a smooth, tailored onboarding experience to help you settle into your new role. Feedback & Improvement: Your feedback helps us continuously improve and enhance the candidate experience for others. Create an account by clicking ‘Sign In’ at the top of the page to set up personalized email alerts when new roles that match your aspirations become available.