Regulatory Compliance & Inspection Readiness Lead
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Sciences Compliance to build and oversee the regulatory sciences compliance framework across Strategy, Operations, Labeling, Global Safety, and Medical Safety. The role ensures alignment with regulatory requirements and inspection readiness while driving risk management and continuous improvement. Hybrid work and Cambridge, MA location offered. #J-18808-Ljbffr Alnylam Pharmaceuticals
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Compliance & Inspection Readiness Lead in Cambridge, MA vacancy
- ...Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to drive inspection readiness and compliance for... ...through audits and CAPA closures. The position demands deep regulatory knowledge, experience with multiple modalities, and...Suggested
- ...General Brigham, located at 60 Blossom Street, seeks a Regulatory Affairs & Compliance Manager to lead cGMP documentation, regulatory submissions, and QA... ...for radiopharmaceuticals. The role ensures inspection readiness and adherence to FDA, MA DPH, MA Board of Pharmacy...Suggested
- Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will drive governance, risk-based strategies, and a high-quality culture across manufacturing and testing operations in support...Suggested
$151.2k - $226.8k
...quality records support consistent compliance across functions and regions.... ...complete, traceable, audit-ready, and meet data integrity... ...overdue items, training compliance)Lead QMS simplification/... ...environmentsExperience supporting QMS-related inspections and audits QMS design,...Suggested- InterSystems is expanding its cloud compliance and security capabilities to support government cloud offerings and... ...are seeking a FedRAMP / GovRAMP Compliance Program Lead to build and lead our authorization readiness program. This cross-functional, high-visibility role...Suggested
$151.2k - $226.8k
...quality records support consistent compliance across functions and regions.... ...complete, traceable, audit-ready, and meet data integrity... ...items, training compliance) Lead QMS simplification/optimization... ...supporting QMS‑related inspections and audits QMS design, lifecycle...Contract workFor contractorsFor subcontractorWork at officeVisa sponsorshipFlexible hours- ...Summary/Objective : The Lead Superintendent oversees the full... ...Safety: Enforce compliance with all safety laws and regulations... ...Safety Manager Manage safety inspection reports, verify remediation... ...behaviors below when they are ready to be promoted to General...Contract workFor subcontractorWeekend work
CALLAHAN INC
Revere, MA2 days ago $136.4k - $253.2k
...Analytical Data Science is recognized as a leading hub for top industry talent,... ...as an agile workforce to deliver regulatory commitments across the portfolio. We... ...accountable to the TA leadYou ensure compliance and inspection readiness by establishing robust quality...Full timeLocal area$103.45k - $169.96k
As the Organization Readiness Program Lead, you will execute on and support the Group Benefits Underwriting Transformation strategy. You will collaborate closely with the Underwriting Transformation team and cross-functional Group Benefits partners as required.You are...Full timeWork experience placementH1bWork at officeRemote workVisa sponsorshipWork visaFlexible hours3 days per week- The Global Study Lead (Sr. Manager, Clinical Operations... ...within budget, and in compliance with applicable... ...of, Health Authority Inspections and internal QA auditsEnsure... ...state of inspection-readiness, collaborating with R&... ...Research, Commercial, Regulatory, Bio Analytical,...Full timeTemporary workLocal areaRemote workFlexible hours
- ...Job Summary: Responsible for leading and maturing the Validation... ...Validation (CSV) program, ensuring compliance with GxP and FDA... ...compliance gaps, supporting audit readiness, and overseeing validation... ...for FDA audits and support inspection readiness activities. Oversee...
- ...for the Quality Control Microbiology Laboratory to lead testing, EM programs, and regulatory compliance in a regulated cGMP environment. Responsibilities... ...and products, and ensuring data integrity and inspection readiness. The role requires strong leadership and deep knowledge...
$17.5 - $26 per hour
...GENERAL SUMMARY & SCOPE The Lead Cashier (LC) is responsible... ...(operating procedures and compliance standards with an emphasis on... ...register functions, associate exit inspections and cashier chat in/outs,... ...fixtures to ensure guest-readiness at all times. Maintain prompt...Full timePart timeWork experience placementLocal areaFlexible hoursShift workAfternoon shiftUlta Beauty
Watertown, MA3 days ago$48 per hour
Clean Harbors in Breslau, ON location is currently looking for a Lead Heavy Duty Mechanic to join our team. The ideal candidate... ...and completes required safety activities such as monthly inspections, updates safety boards, conduct daily toolbox talks, etc as per...Full timeCasual workWeekend workClean Harbors
Cambridge, MA12 days ago$103.45k - $169.96k
Position Overview As the Organization Readiness Program Lead, you will execute on and support the Group Benefits Underwriting Transformation strategy. You will collaborate closely with the Underwriting Transformation team and cross‑functional Group Benefits partners as...Full timeWork experience placementH1bWork at officeRemote workFlexible hours3 days per week- ...Quality Assurance professional to assure GCP compliance for sponsored Clinical Development... ...programs, outsourcing governance, and inspection readiness across global studies. The candidate will lead QA initiatives, ensure regulatory alignment, and act as a key liaison with...
- ...clinical trials, ensuring patient safety, data integrity, and regulatory compliance. The role partners with study teams, CROs, and Quality... ...emphasizes cross-functional collaboration, preparation for inspections, and continuous quality improvement within a hybrid #J-188...
- ...Health is seeking a Sr, Manager, Business Compliance to lead Medicare appeals compliance, aligning... ...on managing CMS inquiries, audit readiness, and cross-functional risk management. The position requires deep Medicare regulatory knowledge, strong communication, and ability...
- CSL is seeking a Manager, Regional Regulatory Lead to drive regulatory strategy for our biotherapies... ...of regulatory dossiers, ensure compliance with global and regional requirements,... ...evolving regulations, and support inspections and audits. This position offers the opportunity...
CSL
Waltham, MA15 days ago - ...President of Quality Assurance to lead its quality strategy across... ...governance, ensuring inspection readiness, and leading a team to maintain high standards of compliance and patient safety. The ideal... ...leadership presence and expertise in regulatory inspections. A competitive...
$185.37k - $308.95k
Associate Director, Medical Review Lead, MSRM Who we are At Agios, we are fueled... ...products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to... ...system and process improvement. Support inspection readiness by identifying quality issues, contributing...Temporary workRemote workWork from homeFlexible hours3 days per week$148.5k - $214.5k
...Framingham, MAAbout the jobAre you ready to shape the future of medicine?... ...roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable... ...consultation meetings with agency, site inspections, or written responses to Agency’...Full time- ...experienced Computer System Validation (CSV) Lead to oversee validation activities for... ...lifecycle management, FDA and global regulatory compliance, validation documentation, risk... ...audits, customer audits, and regulatory inspections. Mentor junior CSV engineers and provide...
$90.6k - $150.59k
...currently initiating a search for an Ancillary Inspection Team Leader to join our exceptional... ...company of WSP, one of the world's leading engineering and professional services firms... ...objectives, goals and challenges. Are you ready to get started?WSP USA (and all of its U...Work at officeLocal areaRelocation packageFlexible hoursNight shift- ...world. Primary ResponsibilitiesThe Trenchless Geotechnical Team Lead will report to the Trenchless Services Engineering Lead, having... ...logging, and performing trenchless construction oversight and inspection. As well, strong written and verbal communications skills are a...For contractorsLocal areaRemote work
$99.2k - $134.68k
...employees and visitorsEnsure daily facilities inspections are conducted and documented, confirming... ...Senior Director of Human Resources on compliance related issues for all worker safety... ...planning with department and senior leaders; lead and project manage office renovations,...Full timeContract workFor contractorsWork at officeLocal areaWorldwide$150k - $225k
...operational oversight, and regulatory compliance for maintenance operations... ...while ensuring regulatory readiness and effective stewardship of... ...federal regulations. They will lead a multidisciplinary team of... ...support accreditation and inspection readiness. Ensure ongoing...Contract workLocal area- .../Basel and collaboration across cross-functional teams. The candidate will author SOPs, develop risk-based GCP programs, and lead inspection readiness while coordinating with internal and external partners in a fast-paced startup #J-18808-Ljbffr Monte Rosa Therapeutics
$34.28 - $47 per hour
## Lead Facilities Maintenance TechnicianApplylocations... ...meet production and compliance requirements.The role... ...on product quality, regulatory compliance, and... ...regulations* Conduct safety inspections and enforce safe work... ...and ensure regulatory readiness (e.g., fire systems, emergency...Temporary workFor contractorsLocal areaShift workWeekend work- ...Lead Structured Cabling TechnicianThe Lead Structured Cabling Technician is responsible... ...AP placement or configuration as needed.Compliance and Quality Assurance:Ensure all... ...local regulations.Conduct thorough quality inspections to guarantee system reliability and performance...For contractorsLocal area
ACAV and Associates LLC
Boston, MA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Compliance & Inspection Readiness Lead. Be the first to apply!
Related searches
- regulatory scientist Cambridge, MA
- regulatory cmc Cambridge, MA
- clinical research regulatory Cambridge, MA
- food regulatory Cambridge, MA
- regulatory Cambridge, MA
- regulatory technician Cambridge, MA
- regulatory accountant Cambridge, MA
- regulatory engineer Cambridge, MA
- regulatory executive Cambridge, MA
- regulatory contract Cambridge, MA