Sr Manager, Compliance

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Your role at Vantive We are looking for a Sr Manager Quality Compliance responsible for driving the Vantive inspection readiness program and participating in quality global internal audit program: Ensure Inspection readiness and compliance to company quality policies, regulations and standards globally Collaborate cross-functionally within Vantive functions/businesses. Grow the quality auditing capability within the organization utilizing expertise, knowledge and experience of best-practice methodologies and practices in industry. What you’ll be doing To succeed in this role, the candidate should have extensive quality auditing and quality compliance leading experience and drug & medical device competencies. Travel will also be required for compliance visits, Internal audit execution, inspection preparations and on site support. Drives continuous quality improvement and inspection readiness initiatives. Performs global quality compliance audits as a team member and/or lead as required. Communicates results of audits and evaluations in reports and presentations. Evaluates audit responses for adequacy, including root cause, timeliness as well as utilizes knowledge to facilitate appropriate corrective actions. Resolves complex issues and escalates concerns through business and Quality Management. Serves as a cGMP consultant/subject matter expert and provides researched and supported opinions to complex compliance issues. Interacts with all levels of internal management across functions and business units. Participates in and/or supports preparation of regulatory agency inspections and/or responses to external observations. Maintains all organizational and professional ethical standards, while actively advocating and monitoring quality compliance. Actively supports continuous improvement of the audit program and Compliance strategy. Participates in special projects/investigations as needed. Lead compliance activities such inspection readiness preparations, coordination and follow-up of mock-inspections. Lead or participate in audit risk calculation strategy. Lead or participate in site risk program management and drive improvements. Acts as a mentor/coach to guest auditors and new hires. What you’ll bring Master degree in Science or Engineering Thorough knowledge of applicable Global quality regulations and standards. Minimum 5 years of experience as Global quality corporate auditor. Minimum 15 years of experience in quality organization of pharmaceutical/ medical device company. Site Quality Leading experience in drugs or medical device company Experience in Pharmacovigilance and Clinical is a plus Demonstrable multitasking and project management skills Must be willing to travel up to 50% both domestically and internationally Excellent verbal and written communication skills, including presentation skills Strong courage of conviction, conflict resolution, interpersonal and influencing skills Strong technical, analytical, judgment and problem-solving skills Ability to build relationships across functional boundaries at multiple levels internally /externally Ability to independently make quick, sound decisions with limited data and execute appropriate judgment on when to elevate information Ability to be self-motivated and work independently within defined timelines Working knowledge of quality system software (e.g. Trackwise) Good working knowledge of Windows based applications (e.g. Word, Excel, PowerPoint) Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. #J-18808-Ljbffr