Senior Clinical QA Program Lead: Audit Strategy
Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine is hiring a Manager, Clinical QA Program Lead to drive audit strategies and ensure GxP compliance across therapeutic programs. The role can be located in multiple sites including US and Europe; travel as needed. You will lead domain-specific QA audits, guide CAPA processes, and partner with audit teams to strengthen quality systems and regulatory readiness across the organization. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
- Johnson & Johnson is currently recruiting for a Manager, Clinical QA Program Lead with two openings. Location options include Raritan... ...China and Madrid, Spain. Role involves leading GCP audits and developing audit strategies across therapeutic areas. The position requires at...Suggested3 days per week
$102k - $177.1k
...Quality Job Sub Function Clinical Quality Job Category Professional... ...for a Manager, Clinical QA Program Lead-Two Openings ! This... ...EMEA- Requisition# R-094833 Audit Strategy Main responsibilities will... ...significant information with senior leaders. Proactively seeks...SuggestedLocal areaImmediate start3 days per week- Merck & Co. seeks a Senior Director, Clinical Data Management TA Lead for Melanoma to oversee data management across therapeutic areas, drive portfolio strategy, and ensure quality and regulatory compliance. The role partners with TA, Geography, and Capability leads to...Senior
- MSD Malaysia is seeking a programming professional to support statistical programming activities for clinical trial data analysis. The role requires developing SAS programs to create and validate analysis datasets for Clinical Study Reports and regulatory submissions. Applicants...Senior
- CSL Behring is seeking a Senior Clinical Scientist to advance cardiovascular-renal programs in a hybrid role based in King of Prussia, PA or Glattbrugg, Switzerland.... ...projects, reporting to a Global Clinical Scientist Lead, ensuring quality and regulatory compliance...Senior
$117k - $184.2k
Job DescriptionThe Senior Clinical Scientist provides scientific leadership... ...of a clinical development program within the assigned therapeutic... ...Scientific LeadershipServe as the lead Clinical Scientist for... ...assessments align with development strategy.Maintain knowledge of...SeniorFull timeFor contractorsSecond jobLocal areaFlexible hours- ...Senior Clinical Project Manager (Oncology) - Remote, US ICON plc is a world-leading healthcare intelligence and clinical research organization... ...radioligand-based clinical programs. What You Will Do:... ...practices into project management strategies. Contributing to...SeniorRemote workFlexible hours
- ...Senior Clinical Project Manager (Oncology) - Remote, US ICON is a global... ...you will be responsible for leading and manage projects,... ...radioligand-based clinical programs. What You Will Do: You... ...practices into project management strategies. Contributing to organizational...SeniorRemote work
$173.2k - $272.6k
...leader for the role of Senior Director, Stability Operations and Device Program Management. This position... ..., while also leading device program management... ...regulatory submissions, clinical supply, and lifecycle management... ...product development strategies, key milestones are...SeniorFor contractors$117k - $201.25k
...merit.Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function... ...compound-specific Clinical Pharmacology strategies for supported programs, including interactions with... ...The Principal Scientist independently leads the day-to-day clinical pharmacology...Full timeLocal areaImmediate start- Creative Solutions Services, LLC is seeking a Senior SAS Programmer with 10+ years in the clinical domain to drive SDTM/CDISC workstreams in a CRO/Pharma setting. You will lead complex SAS programming efforts and mentor junior staff. You will develop advanced SAS macros...Senior
$122k - $212.75k
...recruiting for a Senior Manager,... ...for the quality strategy and quality aspects... ...PAI and agency audits for the product... ...the necessary QA resource for global... ...products.Leads a comprehensive... ...Quality throughout clinical, DS, DP, FF &... ...term incentive program.Subject to the...SeniorFull timeLocal areaImmediate start- ...Function: Discovery & Pre-Clinical/Clinical DevelopmentJob... ...the best talent for a Senior Principal Scientist,... ...teams to advance biologics programs from discovery through... ...planning, and program strategy.The preferred candidate... ...integrator, technical lead, or cross-functional liaison...SeniorFull timeLocal area
$147.6k - $180.4k
...by our shared purpose: leading the fight against MASH.... ...strengthening our workforce strategy to ensure we have the... ...narratives, support audits / inspections and responsesProduce... ...)7-10 years in GMP QA / QMS with strong... ...Employee Assistance Program for employees and their...SeniorMinimum wageFull timeLocal areaFlexible hours- Merck & Co., Inc. is seeking a Principal Trial Manager to lead data management strategies across one or more drug or vaccine trials. You will drive... .... The role requires a BA/BS with at least 6 years in Clinical Data Management or related fields and 3+ years in formal...Senior
- ...Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...searching for the best talent for a Senior Principal Scientist,... ...decision‑making for biologics programs. This role is deeply technical... ...Manufacturing and Controls (CMC) strategies and program planning....SeniorFull timeLocal area
- CSL Plasma Inc. is seeking a Senior Pharmacovigilance professional to serve as a case-management SME for ongoing clinical trials. You will ensure compliance with GxP and PV processes... ...plans, and coordinate inspections and audits. Lead vendor oversight for PV activities,...Senior
- ...Gastroenterology team in Horsham, PA, focusing on clinical trial leadership and strategic medical... .../PharmD, with a strong track record in leading Phase 3b and 4 clinical trials.... ...submissions and developing data dissemination strategies. A background in Gastroenterology,...Senior
$142.4k - $224.1k
...TMed) drives early clinical development of... ...clinical pharmacology strategies spanning first-in-... ...trials and programs in collaboration with... ...development teams. Leads the development of... ...regulatory agencies and audits/inspections, and... ...and mitigation, senior management presentations...Full timeFor contractorsLocal areaWorldwideFlexible hours- ...Function: Discovery & Pre-Clinical/Clinical... ...the best talent for a Senior Principal Scientist, Bioanalytical... ...and clinical-stage programs, there may be some responsibility... ...business systems.Lead regular meetings with... ...risks and mitigation strategies.Collaborate with...SeniorFull timeWork experience placementLocal areaWorldwide
- Merck & Co., Inc. in Rahway, NJ seeks an Associate Director to lead the consumer patient adherence strategy for our PAH drug. You will own strategy, execution, and optimization of the adherence program, collaborating with Marketing, Patient Services, Market Access, Digital...Senior
$156.9k - $247k
...Technical and Engineering Lead - Inhalation Programs (Director Equivalent)Our company... ...of device development strategies. This individual will be expected... ...support and influence clinical and commercial inhalation combination... ...and present ideas to senior leadershipExcellent...Full timeFor contractorsLocal areaWorldwideFlexible hours$129k - $203.1k
...Quality Assurance (QA) is an independent... ...activities and auditing and provide support... ...the company’s non -clinical studies and internal... ...and Operation Leads, support the implementation... ...of the QA strategy. Independently facilitates... ...major project/program areas as related...Contract workFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- Southland Industries Inc. in Horsham, Pennsylvania is seeking a Quality Manager responsible for overseeing all quality activities on site. The ideal candidate will develop and maintain quality standards while ensuring compliance with contractual obligations. Applicants ...Senior
$173.2k - $272.6k
Job Description The Senior Director, Clinical Data Management Therapeutic Area (TA) Lead, Hematology - provides strategic and operational... ...and digital enablement across programs, while driving quality,... ...(Therapeutic Area) portfolio strategy and prioritization, developing...SeniorFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$231.9k - $365k
...(12 anatomic pathologists, 3 clinical pathologists, and approximately... ...matter expert and influences strategy from early discovery through... ...works with multiple program development teams. Key responsibilities... ...-site, including:An industry-leading suite of on-site in vitro and...SeniorFull timeFor contractorsLocal area- ...Clinical Research Associate - East Coast ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive... ...innovative treatments and therapies. Our FSP dedicated program is looking for someone to monitor Oncology...SeniorFlexible hours
- Responsibilities Support statistical programming activities for clinical trial data analysis. Develop SAS programs to create and validate analysis datasets... ..., EMA, etc.). Collaborate with biostatisticians, project leads, and other stakeholders in ensuring project plans are...SeniorFor contractors
$274.5k
...SummaryThis position is for a Clinical Development Senior Medical Director within the atirmociclib program. This individual contributor... ...supporting clinical trial(s) and lead sub teams in clinical... ...create and refine development strategies.Represent the company in external...SeniorPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$162k - $202k
...currently seeking a Principal Biostatistician in a hybrid role based in King of Prussia, PA, or Waltham, MA. You will lead statistical strategies for clinical programs and ensure high-quality analyses for regulatory submissions. The role drives study design, analysis plans,...
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