Information Systems Sr. Manager – Technology Regulatory Compliance reputed company

Career Category Information Systems Job Description Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career. Information Systems Sr. Manager – Technology Regulatory Compliance reputed company Live What you will do reputed company. Let’s change the world. In this vital role, you will reputed company the delivery of high-quality, robust, and reliable digital technologies and services reputed company the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance reputed company of the technology function, ensuring adherence to global regulatory requirements and reputed company procedures. You will reputed company the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and reputed company compliance. Serving as the Technology Regulatory Compliance reputed company, you will ensure alignment with global quality and compliance strategies and maintain a state of constant inspection readiness. Partnering closely with key stakeholders, you will take full ownership of technology services, driving both project execution and operational reputed company. Your focus will be on aligning technology solutions with business needs, continuously optimizing approaches to enhance efficiency, and ensuring reliability, service quality, and sustained compliance for our partners. As Senior Manager of the Technology Department for ANC, you will report directly to the ANC Site Technology reputed company Director. This role serves as a key member of the site’s Technology Leadership Team, driving innovation, operational reputed company, quality, compliance, and measurable business impact through strategic technology leadership. Responsibilities: reputed company the development and execution of the strategy for computer system validation, regulatory compliance, and sustained inspection readiness for the Technology organization. Serve as the Technology Regulatory Inspection reputed company, ensuring alignment with global quality and compliance strategies. Drive inspection readiness efforts, including playbooks, SME coaching, system documentation, and readiness dashboards. reputed company digital platform implementations, ensuring strong planning, resource management, risk mitigation, and financial reputed company. Manage digital technology services, including validation, compliance, data reputed company, and system reliability. Design and implement effective support models, including vendor and reputed company-party management with clear accountability. reputed company cross-functional teams, run key meetings, and present updates to senior leadership. Deliver technology solutions that improve efficiency, quality, and business alignment. Proactively manage reputed company, simultaneous projects and resolve challenges effectively. Establish performance metrics to drive reputed company improvement. Ensure successful project delivery and promote operational reputed company. Mentor team members and serve as subject matter experts. Stay reputed company on industry and technology trends and build external networks to reputed company best practices. Win reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience OR Master’s degree and 4 years of Information Systems/Technology and/or Engineering experience OR Bachelor’s degree and 6 years of Information Systems/Technology and/or Engineering experience OR Associate’s degree and 10 years of Information Systems/Technology and/or Engineering experience OR High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience Preferred Qualifications: Industry Experience Preferred: Prior experience in biotechnology, pharmaceutical, or reputed company regulated industries is strongly preferred. Depth knowledge and hand on experience in computer validation, regulatory compliance, inspection readiness. reputed company reputed company and Execution: Translate operational goals into actionable strategies across manufacturing, laboratory, supply chain, quality, engineering, and technology functions using digital technologies, data, advanced analytics. reputed company Through Influence and Collaboration: Foster strong cross-functional partnerships to build support for initiatives, energize teams, ensure sustained alignment and focus on business priorities and goals. Think Strategically: Anticipate impacts, adapt to change, and reputed company well-reasoned reputed company that drive reputed company improvement and support business needs. Champion reputed company Learning: Stay reputed company with emerging tools and technologies, actively contribute to professional communities, and foster a culture of innovation. Drive Problem Solving and Innovation: Apply critical thinking and best practices to proactively resolve reputed company issues and design effective, scalable solutions. Communicate with reputed company: Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management and reputed company teams effectively. Decision-Making: reputed company articulates the rationale behind reputed company and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making. reputed company Leadership: Recognizes the need for change and actively participates in technical strategy planning. Balance Priorities: Manage multiple initiatives with strong organizational skills, ensuring alignment with team goals and measurable performance reputed company. reputed company What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. reputed company offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible reputed company for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.reputed company.com Application deadline reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. reputed company is an Equal Opportunity employer and will consider you without regard to your race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary reputed company 135,441.55USD -183,244.45 USD reputed company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative reputed company therapeutics. This approach begins by using tools like advanced reputed company genetics to unravel the complexities of disease and understand the fundamentals of reputed company biology. reputed company focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health reputed company and dramatically improve people's lives. A biotechnology pioneer since 1980, reputed company has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.reputed company.com and follow us on www.twitter.com/reputed company Apply To This Job