Quality Leader, Capital Projects | GMP & Regulatory
Merck
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 Merck & Co.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Quality Leader, Capital Projects | GMP & Regulatory in West Point, PA vacancy
- ...Point is seeking an Associate Director, Quality to provide quality direction for a Drug Substance capital project. You will lead GMP compliance, quality systems, training, change... ...the site. This role requires strong CGMP/regulatory knowledge, leadership, and the ability to...QualityProjectRegulatory
- MSD is seeking an Associate Director of Quality to provide direction for a Drug Substance capital project and oversee quality systems. The role requires strong CGMP knowledge, regulatory interaction, and leadership across cross-functional teams. The candidate will lead...QualityProjectRegulatory
$131k - $210k
...Responsibilities Ensures the quality, accuracy, and... ...to adherence to stated project goals, as well as legal... ...compliance with legal, regulatory, and IPS project... ...including both building and GMP cleanroom compliance... ...Hathaway company, is a global leader in technical consulting...QualityProjectRegulatoryFor contractorsWork at officeFlexible hoursIPS-Integrated Project Services, LLC
Blue Bell, PA2 days ago$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- ...Behring in King of Prussia, PA, seeks a Quality Manager - USA to support QMS operations and... ...ensuring GDP/compliance, and supporting regulatory readiness across the US operations. Strong... ...’s degree and at least 5 years of GMP quality experience in pharmaceutical manufacturing...QualityRegulatoryLocal 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
- ...ensuring methods and documentation meet quality and regulatory standards. The ideal candidate will... ...integrity standards and applicable GLP/GMP requirements. Coordinate analytical... ...teams and external laboratories, tracking project timelines and technical deliverables....QualityProjectRegulatoryContract workRemote workMonday to FridayShift work
RX2 Solutions
King of Prussia, PA7 days ago - ...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
- ...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
GSK
King of Prussia, PA3 days ago $129k - $203.1k
Job DescriptionOur 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...QualityProjectRegulatoryFull timeContract workFor contractorsLocal areaMerck Sharp & Dohme (MSD)
West Point, PA4 days ago- ...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
Dairy Farmers of America
Lansdale, PA2 days ago - ...ensure exceptional service delivery and regulatory compliance for our clients. Key Responsibilities... ...of plan issues. Manage special projects and additional responsibilities as... ...the ability to: Deliver high-quality work while meeting deadlines. Provide...QualityProjectRegulatoryRemote work
Benetrends Financial
Lansdale, PA12 days ago - 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
- ...complex datasets, tables, listings, and figures for regulatory submissions and post-marketing support. The role requires... ...knowledge, and collaboration with statistics and project teams to ensure timely, high-quality deliverables at all stages of development. #J-18808-...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 hoursMerck Sharp & Dohme (MSD)
West Point, PA3 days ago- ...laboratory and benchtop equipment within a GMP-regulated environment. This position... ...to lead critical qualification projects work closely with Quality Engineering Validation and... ...supporting both operational excellence and regulatory compliance. The successful candidate...QualityProjectRegulatoryFull timeVisa sponsorship
CAI
Limerick, PA21 days ago $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 hoursMerck Sharp & Dohme (MSD)
West Point, PA4 days ago$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 shiftKey Bank
Spring House, PA3 days ago- ...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
- ...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
$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- Scientific Leader, Discovery Integration Sciences Business Introduction... ...Probability of Technical and Regulatory Success) assets and unlock... .... Foster inclusive high‑quality scientific and technical collaboration... ...and reports for project teams and decision‑making forums...QualityProjectRegulatoryLocal areaRemote workWork from homeRelocation2 days per week3 days per week
- 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
$137k - $235.75k
...aligned with the clinical development plan, regulatory strategy, and anticipated pharmaceutical... ...significant strategic, regulatory, quality, budget, partner, or timeline decisions... ...to-end execution of assigned diagnostic projects, coordinating contract laboratories, diagnostic...QualityProjectRegulatoryContract workLocal area$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- ...DescriptionAt IPS, we are global leaders in developing... ...architecture, engineering, project controls, procurement,... ...C/Q/V services, and regulatory requirements.You will also... ...requirements and quality standards. Provide consistent... ...and experience in a GMP/Validation discipline with...QualityProjectRegulatoryWork at officeNight shift
Integrated Project Services
Blue Bell, PA3 days ago $173.2k - $272.6k
...Vaccine programs. The leader will be expected to demonstrate... ..., proficiency in Quality Control and ability to... ...analytical issues under GMP regulations)Oversee... ...and negotiation skills.Project management experience including... ...Pipeline Development, Regulatory Compliance, Regulatory...QualityProjectRegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA3 days ago- ...leads simulation modeling projects. They shall lead direct... ...Services is a global leader in developing... ...technology, trends and regulatory environment to successfully deliver capital projects and improve operations... ...efficiently, delivering higher quality and controlling costs....QualityProjectRegulatoryLocal areaRemote workWorldwide
Integrated Project Services
Blue Bell, PA5 days ago - ...deliverables.Broad experience and understanding of regulatory framework and guidelines in the region... ...guidance in strategic, program and project initiatives in cyber security.Bachelor’s... ...business success.At Presidio, speed and quality meet technology and innovation. Presidio...QualityProjectRegulatoryFull timeFor contractorsLocal area
Presidio
King of Prussia, PA20 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Leader, Capital Projects | GMP & Regulatory. Be the first to apply!
Related searches
- quality inspection West Point, PA
- quality intern West Point, PA
- water quality scientist West Point, PA
- quality equipment West Point, PA
- quality West Point, PA
- quality manufacturing West Point, PA
- quality tech West Point, PA
- software implementation project manager West Point, PA
- capital projects West Point, PA
- senior implementation project manager West Point, PA