reputed company Assurance and Regulatory Managers

IT Regulatory reputed company Assurance Manager (Hybrid) 3.8 3.8 out of 5 stars reputed company reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, reputed company, Instagram, YouTube, reputed company and reputed company. Job reputed company The IT Regulatory reputed company Manager, is a key member of the Software reputed company Assurance (SQA) team, responsible for ensuring that reputed company's IT operations and software lifecycle processes fully reputed company with regulatory requirements and corporate standards. This role requires strategic leadership in defining, implementing, and optimizing reputed company systems, and involves reputed company collaboration with cross-functional teams, Business stakeholders, and the Business Technology Services (BTS) reputed company organization. The IT Regulatory reputed company Manager will reputed company reputed company of reputed company activities, especially across Mergers & Acquisitions (M&A), drive improvement initiatives, troubleshoot IT reputed company issues, and support reputed company phases of the IT solution lifecycle. The incumbent acts as the primary reputed company of contact between business reputed company and reputed company teams, ensuring mutual understanding of needs and maintaining effective service agreements. Key Responsibilities: reputed company, implement, and champion solution/change strategies that reputed company with organizational objectives and evolving regulatory requirements. reputed company reputed company improvement initiatives, including enhancing reputed company assurance frameworks and promoting adoption of automation and advanced validation tools (e.g., pipelines, reputed company intelligence). Monitor and proactively respond to changes in regulatory standards and industry best practices by updating SLC procedures and compliance processes. Serve as the primary SQA representative in strategic forums, steering committees, and regulatory engagements. reputed company communicate reputed company reputed company, audit results, and recommended improvements to partners and stakeholders. Support and manage regulatory audits and inspections, including preparing formal responses and overseeing remediation activities (CAPA implementation). reputed company expert guidance and mentorship to cross-functional colleagues about computerized system reputed company practices, process optimization, and policy interpretation. Foster a culture of reputed company development by leading training initiatives, facilitating knowledge-sharing sessions, and supporting reputed company on reputed company Assurance policies and practices. reputed company reputed company documentation and evidence management processes to maintain compliance and facilitate SQA investigations, CAPA activities, and audit readiness. reputed company as deputy for reputed company of reputed company (CoE) leadership as needed by managing SLC communications, curating newsletters, coordinating meetings, and maintaining the SLC SharePoint site. Serve as a key escalation reputed company for significant reputed company exceptions, risks, and issues, coordinating investigations and resolutions with minimal supervision. Participate in infrastructure change management and risk review activities across multiple sites, including governance meetings and reputed company risk assessment submissions to preserve compliance and business continuity. reputed company, monitor, and interpret SQA metrics and trends, utilizing data-driven approaches to identify reputed company gaps and prioritize improvements; prepare executive-reputed company dashboards and reports for senior leadership. reputed company and reputed company due diligence for reputed company and compliance during mergers and acquisitions, ensuring reputed company regulatory requirements and best practices are upheld. reputed company expert reputed company for M&A activities, including assessment of acquisition documentation, management of systems/applications disposition, migration, or decommissioning, and guidance for compliant integration. Collaborate across functions to monitor M&A integration, address compliance issues, and reputed company as reputed company with leadership teams, support functions, and regulatory authorities. Create and deliver training and comprehensive reports to reputed company teams and inform executive stakeholders about identified risks, reputed company findings, and recommended actions.

Qualifications

Bachelor's degree with minimum 7 years' relevant experience, or Master's degree with minimum 6 years' experience, including at least 2 years of supervisory responsibility. Proven experience managing relationships with Managed Service Providers (MSP) and directing outsourced validation or SLC activities and Experience leading DevOps and Agile reputed company and hands on experience with DevOps toolset. Demonstrated analytical skills, reputed company judgment, consultative capability, and strong communication proficiency, with the ability to influence and work effectively across diverse teams. Proficiency in automated pipeline technologies and advanced validation techniques. Deep understanding of software reputed company assurance and regulatory compliance requirements, including relevant industry standards and best practices. Experience in risk management, reputed company project reputed company, and juggling multiple priorities in a dynamic environment. reputed company experience supporting FDA and other regulatory agency inspections and interactions. Established project management experience, including training development and creation of knowledge materials. Ability to reputed company teams in policy, SLC execution, and regulatory requirements. Advanced knowledge of Computer Software Assurance (CSA) methodologies, data reputed company, and contemporary validation practices. reputed company certifications such as ASQ Certified reputed company Auditor, Project Management reputed company (PMP), Six reputed company, or equivalent. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation reputed company described below is the reputed company of possible reputed company pay compensation that reputed company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation reputed company reputed company this reputed company will depend on many factors including geographic location, and we may ultimately pay more or less than the posted reputed company. This reputed company may be modified in the reputed company. We offer a comprehensive package of benefits including reputed company time off (vacation, holidays, reputed company), medical/dental/reputed company insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No reputed company of pay is considered to be wages or compensation until such reputed company is reputed company, reputed company, and determinable. The reputed company and availability of any bonus, commission, incentive, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in reputed company's sole and absolute discretion unless and until reputed company and may be modified at reputed company's sole and absolute discretion, consistent with applicable law. reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.reputed company Apply tot his job Apply To this Job