Quality Systems and Compliance Lead
AstraZeneca
AstraZeneca seeks a Quality Systems and Compliance Lead for an autologous cell therapy manufacturing site in Rockville, MD. The role oversees quality system execution, deviation and change control management, regulatory compliance, and inspection readiness for products in clinical development and commercial manufacturing.
Responsibilities
- Support execution and continuous improvement of site quality systems aligned with regulatory requirements
- Prepare, facilitate, and communicate outcomes of quality governance meetings including Deviation and Change Control Review Boards
- Plan and lead site self-inspections as lead auditor, documenting scope and tracking corrective actions
- Support inspection readiness activities and coordinate regulatory inspection preparation and responses
- Analyze quality data and develop reports, dashboards, and metrics on trends and key performance indicators
Requirements
- 7+ years quality experience with bachelor's degree in science, engineering, or related field
- Experience writing and investigating quality records
- Strong cGMP knowledge and ability to interpret regulatory requirements
- Experience leading or supporting GxP audits and health authority inspections
- Demonstrated quality data analysis, trend identification, and reporting capabilities
- Proficiency with electronic quality systems and Microsoft applications
- Strong facilitation, written communication, and stakeholder management skills
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Quality Systems and Compliance Lead in Rockville, MD vacancy
$100.88k - $151.32k
...support the execution and continuous improvement of site Quality Systems and Compliance activities. The individual will serve as a key point of contact... ...minutes, and track progress of quality actions. • Plan, lead, and document site self-inspections as a lead auditor,...QualityRockville, MD4 days ago- Lentigen Technology Inc. in Gaithersburg, MD is seeking an Associate Director of Quality Assurance (Systems) to lead the Quality Management System, drive GxP compliance, and partner with Clinical Operations and IT. This role focuses on governance, optimization, and cross...Quality
- Miltenyi Biotec, Inc. in Gaithersburg, MD, is seeking an Associate Director of Quality Assurance (Systems) to lead the Quality Systems, QMS, and GxP compliance across operations, with liaison to Regulatory, Technical Operations, and Clinical Development. The role focuses...Quality
- Merck KGaA in Rockville, MD is seeking a Quality Specialist 3 to support Contract Testing Services by ensuring cGMP/GLP compliance and regulatory requirements. The role performs... ...support, and CAPA activities. You will lead root cause analysis, host change control meetings...QualityContract work
$186.23k - $279.35k
...of people living with rare diseases. We lead with breakthrough science, deep disease understanding... ...development, legal, manufacturing, quality, portfolio management, etc.).Monitors the... ...working in a regulatory documentation system (like Veeva).Proficient in English in the...QualityFull timeTemporary workWork at officeAstraZeneca
Gaithersburg, MD4 days ago$107.9k - $195.05k
...Leidos Health & Civil Sector is seeking a Systems Engineer Lead to support the National Institutes of... ...access management, encryption, and compliance with NIH, HHS, and federal security requirements... ...environment.Commitment to quality, innovation, and continuous process improvement...QualityFull timeLeidos
Rockville, MD4 days ago$125k - $160.53k
...Rockville, Maryland. This role involves leading engineering efforts, managing resources across projects, and ensuring quality and compliance in mechanical design. The ideal candidate... ...and knowledge in thermodynamic system analysis. The position offers a full-time...QualityFull time$189.5k - $235k
...Regulatory Affairs-Global Regulatory Lead Vacancy No VN723 Employment... ...submissions for regulatory compliance, in conjunction with the... ...for reviewing and ensuring the quality of detailed scientific and... ...drugs that harness the immune system to treat a broad spectrum of...QualityFull timeWork at officeLocal areaRemote workWorldwideNight shift- Grunley Construction Company, Inc. seeks a senior quality and compliance professional to lead Submittal Management, QC/QA programs, and site inspections on complex government and commercial projects in the DMV. The role requires a bachelor’s in Engineering or Construction...Quality
- Keystone is seeking a Policy & Quality Assurance Lead in McLean, VA. The role ensures alignment with Booz Allen policies and requirements... ...teams, develop test strategies, and oversee cross-system validation to ensure compliance and accuracy. #J-18808-Ljbffr Global Business Ser....Quality
- ...Rossmoor is seeking a Restoration Supervisor to lead restoration projects for our clients, ensuring timely delivery and quality workmanship. You will oversee crews, manage materials and equipment, maintain safety compliance, and communicate with customers to ensure...Quality
$98k - $163k
...Public TrustWhat You Will Do:Lead end-to-end operational and business... ..., technology, policy, and compliance requirements.Support key... ...with government policies and systems of record.Facilitate cross-functional... ...delivery teams, ensuring quality, accountability, and...QualityFull timeFlexible hoursGuidehouse
McLean, VA5 days ago$140k - $150k
...Job Title: Lead Information System Security Officer (ISSO) - CISSP Location : Silver Spring,... ...status, vulnerabilities, configuration compliance, security findings, system and cloud... ...and ensures we deliver results with quality, applying industry best practices and...QualityRemote work- Leonardo DRS is seeking an experienced Lead Assembler for System Integration to join the second shift in Germantown, MD. The candidate will lead... ...quickly to evolving operations and maintaining safety and quality standards. Ideal applicants have extensive assembly experience...QualityAfternoon shift
- ...Larraby, Inc. seeks a Program Manager for ERP Systems to oversee the implementation and... ...with onsite collaboration as needed. You will lead ERP program execution, manage stakeholders, and ensure quality and compliance with momentum/iFAMS systems, with responsibility...QualityRemote work
- ...organizations. We help customers secure critical systems, modernize enterprise technology, and... ...looking for an OT/ICS Systems Engineer Lead to join our team supporting our federal... ...~5 years of experience leading data quality and data reporting ~5 years of experience...QualityWork experience placementFlexible hours3 days per week
$24 - $32 per hour
Select how often (in days) to receive an alert: Lead Assembler System Integration-2nd Shift Location: Germantown, MD, US, 20876 Job ID: 1157... ...specialists who are responsible and accountable for producing quality work to prescribed standards, with a focus on continuous...QualityContract workWork experience placementLocal areaFlexible hoursShift workAfternoon shift- ...Company, LLC is seeking a Manager, Regulatory Affairs to lead regulatory strategy and biosafety-compliance for diverse clinical programs. This remote US role... ...cross-functional partners across Clinical Operations, Quality, Safety, and #J-18808-Ljbffr The Emmes Company, LLCQualityRemote job
- Your Role: The Associate Director, Quality Systems develops, maintains, and improves the Quality... ..., and meet phase-appropriate compliance standards. This is a cross-functional role... ...Duties and Responsibilities:Team Leadership Lead, mentor, and develop a team of Quality...QualityFull timeFlexible hours
Miltenyi Biotec
Gaithersburg, MD7 days ago $185k - $225k
...Overview LMI is seeking a Cyber Systems Engineer/AI Governance Lead/Solutions Architect to provide full-time senior technical leadership for Department... ...of AI/ML and generative-AI lifecycle concepts, data quality, model/product limitations, human oversight,...QualityFull timeContract workLMI
Tysons, VA1 day ago- ...throughput assays and support method validation projects. You will guide junior staff, ensure GDP/GLP/GCLP compliance, and manage multiple projects with rigorous data quality. The role demands a strong background in ligand-binding assays, immunoassays, and BSL‑2 techniques,...Quality
- ...Senior Global Medical Affairs Lead, Cardiovascular & Renal is a... ...navigates and transforms health systems, leverages digital, advanced... .... Regulatory Insight & Compliance: The Senior GMAL possesses keen... ...for evidence, ensuring high quality, compliant data generation and...QualityHourly payFull timeTemporary workWorldwide3 days per week
AstraZeneca
Gaithersburg, MD5 days ago - ...past experience in engineering, design, or quality control of medical devices, combined with... ...of our customer needs. Analyze quality systems and assess: Quality Management Systems... ...America is the US subsidiary of GMED, a leading Certification Organization, a...QualityFull timeContract workTemporary workWork experience placementRemote workWork from homeWorldwideHome officeFlexible hours
GMED NA
Rockville, MD5 days ago $21.5 - $22.87 per hour
...Culinary Lead, FT With over 58 stores and the largest avocational... ...of exclusive and premium-quality goods for the kitchen and... ...Google reviews. Operations & Compliance · Ensure compliance with food... ...to operate a computer, POS system, keyboards, merchandise scanners...QualityContract workWork at officeLocal areaFlexible hoursNight shiftTouch Of Modern
Rockville, MD5 days ago- The Payroll Tax Lead independently manages payroll tax compliance and related deliverables across federal, state, and local jurisdictions in a multi-state hybrid... ...changes, tax exceptions, agency discrepancies, and system configuration concerns; perform variance analysis,...Full timeTemporary workFor contractorsFor subcontractorLocal areaImmediate start
Financial Industry Regulatory Authority
Rockville, MD1 day ago $19.74 - $25.66 per hour
...Job Description Summary The Team Lead assists in supervising and managing all day... ...store operations while ensuring that 100% compliance exists with all established Company policies... ...recognized brands known for their quality. Rack Room Shoes also offers an assortment...QualityHourly payFull timePart timeCasual workRack Room Shoes
Clarksburg, MD4 days ago$58.08k - $77.44k
...healthcare through its industry-leading exome and genome testing and... ..., ensuring that all building systems within the company are... ...functional projects with Equipment, Quality, Lab Personnel and IT.... ...protective equipment (PPE), and compliance with regulatory standards. Noise...QualityWork experience placementLocal areaGeneDx
Gaithersburg, MD3 days ago- ...opening for an experienced and reliable Lead Journeyman Commercial Service Electrician... ...repair, and maintain a variety of electrical systems, including electrical panels, lighting,... ...a strong reputation for delivering high-quality projects across commercial, industrial, and...QualityImmediate startFlexible hours
Electric Advantage, Inc.
Rockville, MD3 days ago - ...experienced Product Manager to lead the Graph Platform and AI-... ...intelligence into FINRA's AI systems and enabling advanced investigative... ...) where governance and compliance are material constraints Proven... ...or at the right level of quality, assesses alternatives to resolve...QualityFull timeTemporary workFor contractorsWork experience placementFor subcontractorLocal areaImmediate start
Financial Industry Regulatory Authority
Rockville, MD2 days ago - ...firms, including Forrester and Gartner. We are seeking a Lead Business Systems Analyst. This role requires a strong blend of business... ...efforts across multiple platforms and applications Ensure compliance with banking regulations, data governance, and security standards...Local area
Tiger Analytics Inc.
McLean, VAa month ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Systems and Compliance Lead. Be the first to apply!
Related searches