Quality Leader, Capital Projects | GMP & Regulatory
Merck & Co. Inc
Merck & Co. in West Point, PA is seeking an Associate Director, Quality to provide quality direction for a Drug Substance capital project, ensuring compliance with CGMPs and regulatory requirements across training, documentation, change control, inspection management, and the QMS. This role partners with operations to ensure the facility is designed and qualified to meet regulatory standards. The position requires strong leadership, regulatory interaction experience, and the ability to manage #J-18808-Ljbffr
- ...Vice President, Global GMP Clinical Manufacturing... ..., and supply of high-quality, GMP-compliant products... ..., overseeing major capital projects, and leading a comprehensive... ...with senior leaders across various functions... ...manufacturing, quality, regulatory, and technical disciplines...QualityProjectRegulatory
$76k - $121.9k
...preventive actions (CAPAs), monitors quality-system performance and trends, supports regulatory gap assessments and change... ...applicable FDA, EMA, ATMP, and EU GMP Annex 1 expectations; translate identified... ...Strong analytical, facilitation, project-management, and problem-solving...QualityProjectRegulatoryWork at officeLocal area- ...serves as a technical lead and project manager for environmental... ...environmental review processes, and regulatory compliance efforts necessary... ...schedules, budgets, quality objectives, and agency commitments... ...Experience supporting large utility capital programs and multi-state...QualityProjectRegulatoryWork at officeLocal area
$140k - $195k
...lead for engineering design projects, guiding a team of engineers... ...construction, rehabilitation, and capital improvement projects across... ...operations teams. Implement quality assurance and quality control... ...with clients, contractors, regulatory agencies, and project stakeholders...QualityProjectRegulatoryFull timeFor contractorsWork experience placementFlexible hours- ...Qualification, and Validation (CQV) Project Manager to lead CQV projects for GMP facilities. This client-facing role... ...on schedule, budget, scope, quality and safety while collaborating with... ...opportunities to grow in a global engineering leader. #J-18808-Ljbffr JacobsQualityProject
- ...preventive maintenance programs, and align projects with safety, quality, and efficiency goals. You will manage capital improvements, drive reliability, and... ...best practices across facilities, including GMP adherence and regulatory compliance. #J-18808-Ljbffr Lehigh Valley...QualityProjectRegulatory
$117k - $184.2k
...and compliant supply of quality vaccine products to... ...ensure compliance with GMP and safety Develop and... ...peers, and functional leaders Demonstrated leadership... ...communication skills Project Management Experience... ...Understanding and ability to apply regulatory/compliance requirements...QualityProjectRegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workWeekend work- ...to identify and prioritize capital improvement projects. Recommend expense or capital... ..., and suppliers to obtain quality products and services at... ...current DFA guidelines and regulatory requirements and proper reporting... ...manufacturing practices (GMP) and work in a manner...QualityProjectRegulatoryFor contractors
- ...engineering, manufacturing, quality, validation, and technology teams... ...:Lead MES deployment projects from planning through go-live... ...activities to ensure systems meet regulatory and user requirements. Develop... ...testing, and validation in a GMP-regulated environment....QualityProjectRegulatoryFull timeLocal areaRemote work
- Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing quality activities and... .... You will partner with Project Management, Manufacturing, Regulatory Affairs, and QA IT to manage batch disposition,...QualityProjectRegulatory
- Merck is seeking an Associate Director to lead end-to-end project management of major supply chain changes, coordinating cross-divisional... ...project governance, and strong collaboration across Regulatory, Quality and Global Supply Chain functions. The ideal candidate will...QualityProjectRegulatory
- ...for pilot plant facilities and project teams to ensure microbiology data meet compendial and quality standards. Key... ...Formulations). • Provide CMC regulatory submission support with respect... ...to solve problems. • Works to GMP standards as appropriate. • Follow...QualityProjectRegulatoryContract work
- ...AMA-ALU CORP in Hatfield, PA is seeking an experienced Quality Control Supervisor to lead all QA/QC functions in a food... ...and CAPA, drive continuous improvement, and ensure regulatory compliance including FDA, GMP, HACCP, and PFAS-related standards. #J-18808-Ljbffr...QualityRegulatory
$131k - $210k
...Responsibilities 1. Ensures the quality, accuracy, and... ...to adherence to stated project goals, as well as legal... ...compliance with legal, regulatory, and IPS project requirements... ...both building and GMP cleanroom compliance... ...Hathaway company, is a global leader in technical consulting...QualityProjectRegulatoryFor contractorsWork at officeFlexible hours- ...including Core, US, and EU Labeling. Objectives: ensure high-quality, regulatory-compliant labeling documents to support safe product use... ...understanding of regulatory labeling standards and scientific concepts; project management and communication skills. Preferred: advanced...QualityProjectRegulatory
$173.2k - $272.6k
...validation, and authoring of regulatory submissions. Under the... ...internal and external GMP manufacturing sites,... ...resource allocation, capital, and consumable budgets, ensuring headcount projections and financial targets... ...(PAT).Engineering & Quality: Strong background in...QualityProjectRegulatoryFull timeFor contractorsLocal areaFlexible hours$18.75 - $25 per hour
...relationships with Key by providing distinctive quality service in branch. Lead Tellers ask... ...issues, and branch compliance with regulatory, security, and internal audit... ...inclusive work environment, challenging projects, accessible leaders, and opportunities to grow in your...QualityProjectRegulatoryHourly payFull timeWork experience placementFlexible hoursShift workDay shift$129k - $203.1k
Job Description Our Quality organization ensures every... ...while meeting all regulatory requirements. Partnering... ...oversight to a Drug Substance capital project according to our... ...is an advocate and leader for the development, execution... ...functions relating to GMP compliance, and...QualityProjectRegulatoryContract workFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...a global health care leader with a diversified portfolio... ...in Safety First, Quality Always, and Inclusion... ...programmatic strategy including regulatory, siting, and tech... ..., due diligence, and capital projects.... ...Manufacturing Practices (GMP), Key Client Relationships...QualityProjectRegulatoryFull timeContract workFor contractorsLocal areaWorldwideFlexible hours$173.2k - $272.6k
...Commercialization Team (DCT) leader is accountable for delivering... ...impact technical, operational & regulatory success or timelines.... ...and Analytical, Regulatory, Quality, and Supply Chain from early... ...to ensure on-time, end-to-end project execution and delivery. Drives...QualityProjectRegulatoryFull timeFor contractorsLocal areaFlexible hours$117k - $201.25k
...recognize their merit. Job Function Regulatory Affairs Group Job Sub... ...Manager, Global Labeling Product Leader to be based in Raritan, NJ;... ...commitment to providing high-quality, compliant, and timely... ...required. Experience leading project teams within a matrix environment...QualityProjectRegulatoryLocal areaImmediate startWorldwide- ...work under a mentor on automation, process operations, or capital projects, contributing to GMP manufacturing and technology initiatives. The role... ...work, collaboration across functions, and adherence to Quality systems and safety protocols, with the chance to develop...QualityProject
$55.57k
...development, and delivering high-quality services. As Clinical Manager... ...treatment interventions, regulatory compliance, and strong collaboration... ...✔ An experienced clinical leader ✔ Skilled in staff... ...managing multiple priorities and projects ✔ An effective communicator and...QualityProjectRegulatoryFull timeFor contractorsWork at officeLocal areaTrial periodWeekend workAfternoon shift£100 per hour
...Summary As VP, Global GMP Clinical Manufacturing... ...manufacture, and supply of high-quality, fit-for-purpose, GMP-... ...closely with senior leaders across DDS, GSC, Finance, Quality, Regulatory, and Technical... ...Oversight of major capital projects, including the Marietta...QualityProjectRegulatoryFull timeLocal areaFlexible hours- Role Lead the global Regulatory Data Office within Johnson & Johnson's Innovative Medicine... ...focusing on data governance, stewardship, and quality for regulatory affairs data.... ...regulatory systems (e.g., Veeva Vault RIM) project leadership High-Value focus on regulated...QualityProjectRegulatoryWork at office
- ...DDQ Director to lead the DDQ organization and ensure GMP computerized systems compliance across Quality, IT, and Manufacturing functions. You will oversee... ...of computerised systems. The role requires extensive regulatory knowledge, leadership of cross-functional teams, and...QualityRegulatory
- ZETA USA Inc. in King of Prussia, PA, is seeking a Project Manager to lead pharmaceutical and biotech capital projects from planning through start-up, ensuring GMP compliance and on-time delivery. You will coordinate cross-functional teams, manage budgets up to multi-million...Project
$173.2k - $272.6k
...SummaryThe Digital and Data Quality (DDQ) Director will lead the... ...management of all quality aspects of GMP computerized systems utilized... ...policies, procedures, and regulatory expectations across assigned... ...& SkillsLean Six Sigma, Project Management Professional (PMP)...QualityProjectRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours- ...Ramboll US Corporation seeks a Senior Managing Consultant in air quality compliance & permitting to lead complex projects within Ramboll's Environment & Health division. You will guide regulatory interpretation, emissions estimation, and air permit preparation for diverse...QualityProjectRegulatory
$173.2k - $272.6k
...Lead, Director- QMS & Digital Quality Governance AnalyticalGlobal... ...Development, Digital/IT Quality, and Regulatory Compliance, the incumbent... ...workstreams, setting project milestones, proactively managing... ...Transformation, Executive Communications, GMP Compliance, Laboratory...QualityProjectRegulatoryFull timeFor contractorsLocal areaFlexible hours
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