Information Systems Sr. Manager - Technology Regulatory Compliance Lead
Amgen Inc
This senior management role leads technology regulatory compliance and computer system validation strategy for Amgen's technology organization. The position ensures adherence to global regulatory requirements, drives inspection readiness, and oversees digital platform implementations while maintaining operational excellence and service quality across technology services.
Responsibilities
- Lead development and execution of computer system validation and regulatory compliance strategy
- Serve as Technology Regulatory Inspection Lead ensuring alignment with global quality standards
- Drive inspection readiness efforts including documentation, dashboards, and team coaching
- Oversee digital platform implementations with resource and financial management oversight
- Mentor team members and establish performance metrics for continuous improvement
Requirements
- Bachelor's degree plus 6 years of Information Systems/Technology/Engineering experience
- Prior experience in biotechnology, pharmaceutical, or regulated industries strongly preferred
- Hands-on expertise in computer system validation and regulatory compliance
- Demonstrated ability to lead cross-functional teams and drive strategic initiatives
- Strong knowledge of inspection readiness processes and compliance frameworks
Vacancy posted a month ago
Similar jobs that could be interesting for youBased on the Information Systems Sr. Manager - Technology Regulatory Compliance Lead in Holly Springs, NC vacancy
$135.44k - $183.24k
...Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel... ...transforming your career. Information Systems Sr. Manager – Technology Regulatory Compliance Lead Live What you will do Let’s do this. Let...Information SystemSeniorRemote workFlexible hours- ...Amgen in the United States seeks an Information Systems Sr. Manager – Technology Regulatory Compliance Lead to steer the strategy for computer system validation and global regulatory compliance, ensuring inspection readiness and alignment with Amgen quality standards....Information SystemSeniorRemote job
- ...Job Description Finance Systems & Transformation Manager Location: Apex, NC Company... ...a highly motivated and technology-minded finance... ...platforms to the VIP (Vermont Information Processing) ERP environment... ...investigate account variances. Lead ERP and Financial Systems...Information System
Rand Cola-Cola Beverages
Apex, NC15 days ago - ...The Quality Control Sr. Associate supports QC Sample Management and Stability team... ..., while ensuring compliance with internal SOPs, regulatory requirements, and... ...in the Laboratory Information Management System (LIMS). Ensure proper... ...analysts and team leads across QC areas to...Information SystemSenior
HireLifeScience.com
Holly Springs, NC3 days ago $225k - $260k
...responsible for oversight and management of pricing, contracting,... ...Company’s products. The incumbent leads contract negotiations,... ...policy interpretation, ensuring compliance with all applicable... ...platforms, and efficient with technology for business insights and communications...SeniorFull timeContract workTemporary workRemote workHome officeAsahi Kasei
Cary, NC3 days ago- ...FUJIFILM Biotechnologies seeks a Senior Director to lead the Drug Substance MSAT pillar from greenfield start-up through stable, scalable... ...and cross-functional teams to ensure robust process control, compliance, and continuous improvement, delivering #J-18808-Ljbffr...Senior
$160k - $175k
...Job Description:The Senior Manager, Manufacturing Sciences & Technology (MS&T) serves as the MS&T Product Lead for a commercial small molecule... ...the technical content of regulatory submissions supporting... ...supply continuity, regulatory compliance, and operational excellence...SeniorContract workAsahi Kasei
Cary, NC4 days ago$154.53k - $165k
...Overview Job Title: Lead Business... ...Overview DB Global Technology, Inc. seeks a... ...NC to implement Information Technology (IT) solutions... ...in Information Systems, Computer Science... ...relationship management by providing... ...and operational compliance utilizing in-house...Information SystemFull timeWork from homeCary, NCa month ago- ...The Director, Quality Systems and Compliance provides strategic... ...Inspections, Documentation Management, GxP Learning, and... ...with global regulatory requirements, and drives... ...health regulations; leads end-to-end... ...and present complex information effectively. \n Strong...Local areaFlexible hoursShift work
FUJIFILM Biotechnologies
Holly Springs, NC27 days ago - ...Job Description CIP Cleaning Lead \n Location: Holly Springs, NC \n Shift:... ...activities for process equipment, ensuring compliance with cGMP standards, and supervising a team... .... \n ~ Working knowledge of CIP skid systems, cleaning validation principles, and cGMP...Shift workNight shiftDay shift
CORE, a Unicon Company
Holly Springs, NC3 days ago $59.29k - $88.93k
...infrastructure Division: Compliance & Lab Opening Date: 09/29... ...Reports to the Utilities Manager-Environmental Compliance. Work... ...stations, industries and collection systems according to sampling... ...requirements and regulations. 6.Informs water/wastewater treatment...Information SystemFull timeLocal areaFlexible hoursNight shiftAfternoon shiftTown of Holly Springs, NC
Holly Springs, NC3 days ago- ...The Quality Control Sr. Associate supports QC Sample Management and Stability team... ..., while ensuring compliance with internal SOPs, regulatory requirements, and... ...in the Laboratory Information Management System (LIMS). Ensure... ...analysts and team leads across QC areas to...Information SystemSeniorContract workShift work
US Tech Solutions
Holly Springs, NC5 hours ago - ...participates in the Technology Transfer (TT) of... ...meetings, manages the raw material... ...effective laboratory systems, ensuring integrity... ...daily work. \n Leads and coordinates... ...requesting laboratory information management system... .... \n Ensures compliance with current Good...Information SystemContract work
FUJIFILM Biotechnologies
Holly Springs, NC27 days ago $17.57 - $22.45 per hour
...search for Browse Jobs. Shift Lead Position Profile The role of... ...in or assisting the Practice Manager or Chief of Staff in guiding... ...campaigns, and other related information; effectively resolve client issues... ...and CE scheduling. Ensuring compliance with all practice policies...Hourly payMinimum wageFull timeTemporary workPart timeLocal areaFlexible hoursShift workWeekend workAfternoon shiftBfcareers
Apex, NC3 days ago- McDonald's - 830 East Williams Street - Responsibilities: Greet guests with energy and professionalism; Assist guests at kiosks and mobile orders; Promote McDonalds App and rewards; Maintain front-of-house cleanliness and guest comfort; Support drive-thru and front counter...
McDonald's
Apex, NC13 hours ago - ...Catering Lead At PaneraAt Panera, our people come first. If you're looking for a place where you can grow, feel supported, be yourself... ...and accurately.As a Catering Lead at Panera, Your Role Includes:Manage and produce catering orders for our guests.Create memorable...Full timeLocal areaFlexible hoursShift workNight shift
Panera
Holly Springs, NC2 days ago - ...Position Overview The Senior Project Manager, Strategy & Execution leads high-impact, cross-functional... ...cost, service, quality, safety, and compliance, providing transparent reporting to... ...initiatives at a site level. EEO Information Fujifilm is committed to...SeniorFull timeShift work
FUJIFILM Biotechnologies
Holly Springs, NCa month ago - ...sports and outdoors. Click the link(s) below to learn more about each position’s responsibilities and requirements. Store Team Lead Positions: Logistics Team Lead ( Operation Team Lead Store Inventory Control Team Lead ( Store Merchandising Team Lead...Full time
Academy Sports + Outdoors
Apex, NC13 hours ago - ...site Reports To: Pathogen Safety Support Lead\n About CSL \n CSL is a global... ...site, partnering with Operations, Quality, Regulatory, MS&T, and Global Pathogen Safety to assess... ...authority. \n ~ Strong stakeholder management and communication skills. \n ~ Ability...SeniorLocal area3 days per week
CSL
Holly Springs, NC13 days ago - ...archiving, document archiving, information lifecycle management. • Hands-on implementation... ...(ADK), Archive Information System (AIS), SAP ILM, retention... ...Infrastructure, Data, Legal, and Compliance teams. Roles & Responsibilities • Lead the onsite design,...Information SystemRemote work
Ventures Unlimited Inc
Cary, NC5 hours ago $13 - $17 per hour
...Shift Lead At Whistle ExpressThe crew follows your lead. Make it worth following. As a Shift Lead at Whistle Express, you are the... ...setter on the lot. You know the site, you know the crew, and when management is not on-site, you are the one running it. This is not a...Flexible hoursShift workTake 5 Car Wash
Fuquay Varina, NC3 days ago- ...people, provide industry-leading training, and empower... ...the fastest-growing pest management companies in the Southeast... ..., brand reputation, and regulatory compliance through professional... ...pipeline, and customer information within the CRM system Partner closely with...Information SystemLocal area
- ...Educate guests on product attributes and information and provide guidance for specific needs/... ...Den/Sunmill Wines. Work with category managers and suppliers to ensure proper pricing and... ...specials and sale information on the PA system. Perform all other duties as assigned by...Information System
Lowes Foods
Apex, NC4 days ago - ...accurate, and documented per applicable regulatory and corporate requirements. Analyst... ...and procedures in order to maintain compliance with legal regulations, health and... ...Experience with Laboratory Information Management Systems (LIMS) Experience performing Bioburden...Information SystemShift work
Mindlance
Holly Springs, NC13 hours ago - We are looking for a Senior Account Manager to drive sales for Lowe's largest regional pro customers. This role involves building relationships, conducting market research, and leveraging product solutions to achieve sales gains. Join us to make a siSenior
Lowe's
Apex, NC2 days ago $16 - $22 per hour
...prescription orders, entering prescription information into the pharmacy system, counting and measuring medications, labeling... ...programs, and opportunities for advancement into Lead Pharmacy Technician, Pharmacy Operations Manager, or Pharmacist training programs. CVS may...Information SystemHourly payFull timeShift workWeekend workAfternoon shiftCVS Corporation
Fuquay Varina, NC2 days ago$17 - $21 per hour
...Description Lead Veterinary Technician Full Time Trinity... ...an AVMA-accredited veterinary technology program preferred; or the equivalent... ...with the support of practice systems • Obtain relevant health history and information from clients and maintain...Hourly payFull timeTemporary workLocal areaFlexible hoursTrinity Animal Hospital
Holly Springs, NC2 days ago- ...be empowered to lead, supported to grow... ...to: IS Service Manager __ Your role... ...delivery Integration technology and architecture... ...Interfaces System Integration: Facilitate... ...standards, and regulatory compliance Evaluates... ...computer science, Information Systems, Business...Information SystemHourly payFull timeTemporary workMonday to Friday
ABB
Cary, NCa month ago $42.4k - $47.4k
...reimbursementResponsibilitiesRelationship Management: Cultivate strong relationships with... ...daily sales activities by inputting information into our systems. We support our customers by... ...personal electronic device that is in compliance with the company's Bring-Your-Own-Device...Information SystemKimball Midwest
Apex, NC2 days ago$25 - $50 per hour
...Role Overview TSA is accepting applications for Lead and Supervisory Transportation Security Officers at airports... ...Supervise screening teams Ensure TSA compliance Train and mentor officers Manage checkpoint operations Disclaimer This is not a...Shift workNight shiftWeekend workAirport Security Careers
Holly Springs, NCmore than 2 months ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Information Systems Sr. Manager - Technology Regulatory Compliance Lead. Be the first to apply!
Related searches
- senior Holly Springs, NC
- senior activities Holly Springs, NC
- senior director community engagement Holly Springs, NC
- srs Holly Springs, NC
- senior level Holly Springs, NC
- senior application security Holly Springs, NC
- senior manager diversity & inclusion Holly Springs, NC
- senior implementation engineer Holly Springs, NC
- senior project manager contract Holly Springs, NC
- senior performance tester Holly Springs, NC