Information Systems Sr. Manager – Technology Regulatory Compliance Lead Job at Amgen (Holly Springs)

Job Description

Join Amgen's Mission of Serving Patients. At Amgen, 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 all 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, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make 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 within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Information Systems Sr. Manager – Technology Regulatory Compliance Lead Live What you will do Let's do this. Let's change the world. In this vital role, you will lead the delivery of high-quality, robust, and reliable digital technologies and services within the Technology Organization, ensuring seamless support for business, project, and daily operations. You will be accountable for the computer systems compliance framework of the technology function, ensuring adherence to global regulatory requirements and Amgen procedures. You will lead the strategy for computer system validation (CSV), regulatory compliance, and inspection readiness for the technology team, proactively driving a culture of quality and continuous compliance. Serving as the Technology Regulatory Compliance Lead, 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 excellence. 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 Lead Director. This role serves as a key member of the site's Technology Leadership Team, driving innovation, operational excellence, quality, compliance, and measurable business impact through strategic technology leadership.

Job Responsibility

Lead 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 Lead, ensuring alignment with global quality and compliance strategies
Drive inspection readiness efforts, including playbooks, SME coaching, system documentation, and readiness dashboards
Oversee digital platform implementations, ensuring strong planning, resource management, risk mitigation, and financial oversight
Manage digital technology services, including validation, compliance, data integrity, and system reliability
Design and implement effective support models, including vendor and third-party management with clear accountability
Lead cross-functional teams, run key meetings, and present updates to senior leadership
Deliver technology solutions that improve efficiency, quality, and business alignment
Proactively manage complex, simultaneous projects and resolve challenges effectively
Establish performance metrics to drive continuous improvement
Ensure successful project delivery and promote operational excellence
Mentor team members and serve as subject matter experts
Stay current on industry and technology trends and build external networks to benchmark best practices

Requirements

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

Nice to have

Prior experience in biotechnology, pharmaceutical, or related regulated industries is strongly preferred
Depth knowledge and hand on experience in computer validation, regulatory compliance, inspection readiness
Bridge Vision and Execution: Translate operational goals into actionable strategies across manufacturing, laboratory, supply chain, quality, engineering, and technology functions using digital technologies, data, advanced analytics
Lead 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 make well-reasoned decisions that drive continuous improvement and support business needs
Champion Continuous Learning: Stay current 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 complex issues and design effective, scalable solutions
Communicate with Clarity: Demonstrate strong verbal, written, and presentation skills to engage stakeholders, senior management and lead teams effectively
Decision-Making: Clearly articulates the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making
Adaptive 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 outcomes

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program
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

Chief Country Compliance Officer Sr Mgr

Oversees the Citi Compliance Risk Management Program for a medium to smaller fra...

Location

Bahamas , Nassau

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Credibility as a subject matter expert and experience of dealing with issues that have a high impact at all levels of the organization
Experience of working with key country level regulators and industry associations
Knowledge of local regulatory requirements and obligations and the ability to identify emerging compliance issues and themes
An ability to influence senior business leaders on all compliance risk-related matters affecting the business. The individual should have the ability to independently challenge, when needed, while at the same time being supportive and solution-based and not being perceived as obstructive
An ability to be “hands on” and “in the trenches” with the direct team, while also bringing a sense of strategic vision and a global sensibility to the function
Ability to navigate and negotiate through conflicting demands to maintain focus on priority objectives while ensuring key stakeholders’ needs are met
Strong team leadership, communication, interpersonal and management skills, with a track record of leading through change and the ability to effectively communicate the strategic vision to various stakeholder groups
Effective negotiation skills, a proactive and “no surprises” approach in communicating issues and strength in sustaining independent views. Strong presentation and relationship management and influencing skills are essential
The ability to thrive and execute in a complex, highly matrixed, global environment
Bachelor’s Degree highly preferred or relevant, equivalent experience. Preference for post graduate degree and/or recognized professional qualifications where applicable. Professional qualifications may include: CRMC or equivalent, CPA, ACA, CIA, CFA, ACAMS, etc. strong technical knowledge of compliance regulations and requirements, experience within a highly complex, global financial institution, regulator or related industry participant.

Job Responsibility

Annual Country Compliance Plan: Preparing, obtaining approval and successfully completing an annual compliance risk management plan, in accordance with the global template and content and presentation requirements, setting out how compliance risk will be managed within the jurisdiction and its constituent parts, and the role to be played by ICRM in order to achieve the plan. Identification of the jurisdictional requirements, accountabilities and the process ownership and monitoring and testing ownership, as well as the determination of suitable staffing, hours required and secured budget in order to achieve the state of compliance within risk appetite will be set out in the plan, which will be reviewed quarterly with the jurisdictional CCC and ICRM, as well as any applicable legal entity, as well as where required by applicable regulatory agencies. The annual country compliance plan must take into consideration the applicable compliance risk assessments and MCAs appropriate to the jurisdiction and its activities.
State of Compliance Reporting: Preparing quarterly, in accordance with the approved global format, and in adherence to all established requirements for the State of Compliance reporting. The State of Compliance report will be presented to the appropriate CCC, BRCC and legal entity Board or Board Audit Committee, or other such Board committee required within the jurisdiction.
Enhancing Governance: Providing a valued interactive program of support and compliance risk management services covering the assessment and reporting of Key Compliance Risks across products, services, functions, legal entities, service centers and the jurisdiction as a whole. Providing stakeholders with insight and practical solutions as well as credible challenge to improve the ethical control culture, and conduct risk environment. Timely reporting of significant local regulatory issues to local, overseas, regional, and global stakeholders. Same-day escalation of regulatory reports received. Maintaining on-going assessment and reporting of the State of Compliance through the relevant corporate governance committees such as country audit committee(s) and/or subsidiary board(s), country coordinating committee and business risk management committee, and other management body(ies). Key Activities Compliance Risk Culture:
Stakeholder Support and Relationships: Developing senior management relationships, including with legal entity management focus, inclusive of non-executive directors (where they exist in the jurisdiction), and the CCO as well as product functional and entity/service center line management. Informing senior management and directors of subsidiary boards, and the country/business management of significant compliance matters that require their attention or action. Proactively anticipate and help the business and functions plan for changes in the compliance and regulatory environment in the country. Provide support to compliance programs and country/business management on policy interpretation and “gray area” exposures. Build and maintain strong relationships with other functional leads, including Legal, Risk Management, including Operational Risk Management, and Internal Audit to create a supportive and seamless compliance and ethical control culture and an appropriate conduct risk environment. Key Activities Processes and Activities:
Regulatory Management and Coordination: Supporting the Citi Country Officer (CCO) in the management and development of regulatory relationships. Coordinating as the key interface with regulators on compliance risk management issues and supervisory exam management matters. Providing same day notification of regulator correspondence to Citi Compliance Officer, Regulatory Liaison and Exam Management CCO and ICRM COO. Providing leadership, coordination and regular interaction with the [insert country] authorities on behalf of ICRM and the Citi franchise. Record regulator correspondence and minutes of regulator meetings on Citi system in line with the Global Regulatory Exam Management Governance and Process Standards. Ensuring prompt recording of, responses to, and escalation of regulatory queries, notices of violations and breaches, any forbearance, and concerns identified. Deliver to regulators and supervisors a valued interactive program of support and assurance in accordance with requirements and appropriate expectations on compliance issues, trends, themes, root cases and impacts relating to governance, regulatory risk management and internal control issues. The overall objective is to earn the regulator’s trust and to establish a strong, independent and professional regulatory relationship across the franchise.
Regulatory Inventory: Ensuring prompt identification, logging in, evaluation and formulation of a plan to address requirements arising from new and amended laws, regulations, rules and other requirements and expectations from regulatory and enforcement authorities.
Regulatory Change Management and Controls: Ensuring that the regulatory change management requirements and processes, along with the regulatory control framework for existing requirements, are effectively operating within the country with respect to the identification, impact assessment and implementation of all applicable laws, regulations, rules and related processes, controls and reporting that impact Citi activities in the jurisdiction.
Anti-Money Laundering Compliance Risk Management (ACRM): Providing strategic direction, oversight, coordination and cooperation in respect of the country’s Anti-Money Laundering compliance risk management program. Partner closely and with the Head of ACRM to ensure a strong linkage between ICRM and ACRM.
Independent Compliance Risk Management (Program and Product/Service/Function focused*): Providing direction and oversight in supporting the ICRM teams in the country related to local requirements and the applicable extraterritorial laws, regulations, relevant Citi policies, standards, and global procedures. Deliver consistent application of program procedures and be accountable to program owners consistent with the ICRM methodology and CRM Framework. *Programs include but are not limited to: Sanctions
Anti Bribery

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Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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