GMP Readiness & Quality Strategy Director
Jobleads-US
ProPharma in Raleigh, NC seeks a senior Quality & Regulatory leader to shape GMP readiness for a multi‑product platform. You will build lean QMS, lead Part 11 strategies, and guide cross‑functional teams through design controls, IQ/OQ/PQ, and vendor qualification across instrumentation, software, and consumables.
You will advise customers on GMP readiness, engage with stakeholders, and help scale the Quality & Regulatory function to support rapid growth in the biotech and pharma space.
#J-18808-Ljbffr Jobleads-US- ...ProPharma in Raleigh seeks an experienced leader in quality, regulatory, and GxP to guide GMP readiness for a biotech/pharma ecosystem, including instrument, software, and consumables. Lead QMS development, Part 11 adherence, vendor qualification, and cross-functional...Suggested
$120k - $140k
...highest standards of product quality and patient safety. As an... ...every batch produced meets GMP/GDP requirements , aligns with... ...the QTA ~ Lead to define strategy of implementation and monitoring... ...Authorities (HAs) inspection readiness ~ Support HA inspections/...SuggestedContract workTemporary workWorldwide- ...highest standards of product quality and patient safety. External... ...that every batch produced meets GMP/GDP requirements, aligns with... ...and the QTA. Lead the strategy for implementing and monitoring... ...launch. Assess and ensure CMO readiness for Health Authority (HA)...SuggestedContract work
- POSITION SUMMARYThe Director, Quality Control provides strategic and operational leadership... ...in accordance with global GMP requirements.The Director QC oversees... ...with the overall control strategy. This role ensures inspection readiness data integrity, and continuous improvement...Suggested
- ...Pharmaceuticals is seeking a Global Program Director - Enablement to drive high‑quality, global cross‑functional project... ...for products, and to lead launch readiness activities across the pipeline and... ...development and commercialization strategies. The position requires a Bachelor’...Suggested
- The Director, Clinical Quality Assurance is primarily responsible for establishing... ...the overall global Quality strategy and initiatives.Position... ...pharmacovigilanceDevelop and implement inspection readiness plans and procedures... ...to ICH guideline, GCP, and GMP as defined by the US Food...Temporary workWorldwide
- ...to improve the diagnosis, prognosis and quality of life of patients.Achieve, Cooperate, Care... ...e.g., FDA, EMA, ANVISA, PIC/S), supports GMP operations, and drives a culture of... ...Risk Management, Supplier Quality and audit readiness. The incumbent will coach and develop their...Local area
- ...grow at pace. The team is looking for a Quality Director to join them. You will report to the... ...regulatory standards. Develop quality strategies, KPIs, and executive reporting that align... ...while maintaining continuous audit readiness. Drive effective root cause analysis and...Permanent employmentLocal areaFlexible hours
- ...the diagnosis, prognosis and quality of life of patients.Achieve,... ...digital quality systems within a GMP-regulated manufacturing... ..., efficiency, and inspection readiness.YOUR ROLEProvide Quality oversight... ...URS, risk assessments, test strategies, and validation summary...Local areaShift work
- ...the diagnosis, prognosis and quality of life of patients.Achieve,... ...executed in compliance with GMP, ALCOA+ data integrity principles... ...site Contamination Control Strategy (CCS).Oversee contamination control... ...staffContribute to site readiness activities and leadership...Local area
- ...Environmental Health & Safety team as the Director of the Plan Review & Recreational... ...(PRRS)! Are you a mission‑driven leader ready to shape safer, healthier communities across... ...streamline workflows for clients.Deliver high‑quality customer service by supporting applicants...Full timeTemporary workWork experience placementSummer workLocal area
- ...chain, the highest standards for quality, and technically advanced... ...FDA 21 CFR Part 820, including GMP, GDP, and data integrity... ...external, FDA) and ensure audit readiness at all times. Support CAPA,... ...duties as assigned by Quality Director. Job Expectations The Employee...Temporary workCasual workWork at officeOverseasFlexible hours
- ...a strategic, hands-on leader who will direct site-wide Quality Assurance and Quality Control in a highly regulated biopharmaceutical... ...manufacturing environment. You will ensure GMP compliance, inspection readiness, robust quality systems, and continuous improvement while...
- ...Supervisor to lead the daily operations of our Quality Control Microbiology Laboratory. This role... ...regulatory requirements Maintain audit-ready lab conditions and manage inventory of... ...communication skills In-depth knowledge of GMP, FDA, USP, and other regulatory standards...
$175k
...applicable hygiene, safety, quality, and regulatory standards, and... ...executed in compliance with GMP, ALCOA+ data integrity principles... ...site Contamination Control Strategy (CCS). Oversee... ...staff Contribute to site readiness activities and leadership forums...Full timeTemporary workWork at officeLocal areaMonday to FridayShift workDay shift- ...sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical... ...to help build out and execute their GMP readiness plan so their first GMP-ready product can... ...controls, design FMEA, and an IQ/OQ/PQ strategy for a combined instrument, consumable,...Work at officeRemote work
- ...Euromed Pharma US Inc is looking for a driven and experienced Director of Quality US to lead and champion quality assurance initiatives. This... ...Additional Responsiblities Maintain inspection readiness at all times across facilities and systems Ensure full compliance...For contractorsLocal area
$138.6k - $257.4k
...Description Summary Job Title: Site Quality Head (Associate Director level) #LI-Onsite... ...standard for inspection readiness, robust management of product... ...Lead site quality strategy and governance to meet Novartis... ...years of experience in a GMP pharmaceutical manufacturing...$144.6k - $265.1k
...Solutions, Microsoft Dynamics, and Sustainability Technology and Strategy. With such a variety of areas to explore, you'll have the... ...manager), ensuring deliverables are being developed and will be ready according to plan. Demonstrated experience as a senior resource...Local area- ...create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and... ...Accenture, shaping the future of businesses worldwide. If you're ready to contribute to the evolving business landscape, this is the...Full timeLive inWork at officeLocal areaWorldwide
$145k - $195k
...aligned, risks are proactively managed, and programs move from strategy through execution with speed, accountability, and transparency... ..., issue resolution, organizational dependencies, and readiness activities across acquired entities and strategic initiatives....Remote work- ...requires disciplined coordination across strategy, operations, and execution. This role shapes... ...planning processes, improve decision quality, and strengthen execution at scale. This... ...planning cycles* Lead the creation of executive ready planning materials that enable faster,...Work at officeWork from homeWorldwideFlexible hoursShift work
- Biocryst Pharmaceuticals, Inc. is looking for a Director of Quality Control located in North Carolina. This role will oversee all Quality Control activities, ensuring compliance with regulations and internal standards. The ideal candidate will have advanced degrees and...Remote job
- ...Career Move Starts Here! The Role: Quality Manager Location: Raleigh, NC... ...to establish quality assurance strategies in all phases of the product development... ...trust and collaboration. Ready to take the next step? Apply today and...Permanent employmentLocal area
$195k - $215k
...Job Description Site Head of Quality Location: Raleigh, North... ...Assistance: Provided Reports To: Director, Quality Technical Operations... ...initiatives. Lead site readiness for regulatory inspections,... ...Opportunity to lead quality strategy at a growing sterile pharmaceutical...Temporary workCasual workWork at officeLocal areaRelocation package- ...re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great... ...colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study...Full timeFor contractorsLocal area
$155.6k - $306.8k
Position Summary Our Deloitte Strategy & Transactions team helps guide clients through... ...to team development and high-quality client deliveryA successful candidate would... ...investments and use digital trends to build future-ready strategies.QualificationsRequired:...Local areaVisa sponsorship$112k - $153k
...to Raleigh, NCThe QA Manager, GCP is responsible for: Ensuring quality oversight and quality assurance and quality by design activities... ...and site level, as applicable and contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi....Temporary workLocal areaFlexible hours$85k - $120k
...Bonus based on performance ~ Company car Position: Quality Control Manager Description: Cooper Tacia General Contracting... ...QC meetings with subcontractors and field personnel to ensure readiness, approved materials, and clear quality expectations. •...Full timeContract workFor contractorsFor subcontractorWork at office- ...Planning Location: Raleigh, NC Reports To: Director, Global Tax Planning Position... ...evaluating, designing, and executing tax strategies across U.S. international and non-U.S. jurisdictions... ...planning-related documentation, audit readiness, and post-implementation follow-through...Local area
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