GMP-Ready QA/RA Director Quality & Regulatory Strategy
ProPharma
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 execution with a lean, scalable approach. The role requires 10+ years in life sciences quality/regulatory, and a proven track record building quality systems from the ground up to support GMP projects and customer partnerships. #J-18808-Ljbffr ProPharma
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the GMP-Ready QA/RA Director Quality & Regulatory Strategy in Raleigh, NC vacancy
- ...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...Quality
- ...deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance,... ...out and execute their GMP readiness plan so their first GMP... ...FMEA, and an IQ/OQ/PQ strategy for a combined instrument... ...GMP workflows ~ Led QA for GMP drug manufacturer...QualityWork at officeRemote work
- ...in providing unique, accessible, and high-quality medications, Azurity leverages its integrated... ...description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory...QualityFull timeLive inWork at officeWork from home
Azurity Pharmaceuticals - US
Raleigh, NCmore than 2 months ago $120k - $140k
...standards of product quality and patient safety... ...produced meets GMP/GDP requirements... ...Technical Operations, and Regulatory Affairs ,... ...~ Lead to define strategy of implementation... ...(HAs) inspection readiness ~ Support HA inspections... .... Experience in QA operation,...QualityContract workTemporary workWorldwideSobi
Raleigh, NCa month ago$120k - $140k
...standards of product quality and patient safety... ...produced meets GMP/GDP requirements,... ...Technical Operations, and Regulatory Affairs,... ...QTA Lead to define strategy of implementation... ...ensure CMO inspection readiness for Health... ...with experience in QA operation, production...QualityContract workTemporary workWorldwide- QA Operations Sr. ManagerAt Guerbet, we... ...diagnosis, prognosis and quality of life of... ...safety, quality, and regulatory standards, and in... ...compliance with GMP, ALCOA+ data integrity... ...Control Strategy (CCS).Oversee contamination... ...to site readiness activities and leadership...QualityLocal area
- Digital QA ManagerAt Guerbet, we build... ...diagnosis, prognosis and quality of life of... ...safety, quality, and regulatory standards, and in... ...systems within a GMP-regulated manufacturing... ..., and inspection readiness.YOUR ROLEProvide... ...assessments, test strategies, and validation...QualityLocal areaShift work
- Vaxcyte, Inc. is seeking a Sr. Director of Quality Assurance for Quality... ...release, and in-process testing strategies for Drug Substance and Polysaccharides... ...Development, MSAT, QC, Regulatory, and CMOs. The role requires... ...and leading high-performing QA teams, driving continuous...QualityRemote job
$175k
...Science is seeking a Sr QA Operations Manager to... ...hygiene, safety, quality, and regulatory standards, and in alignment... ...in compliance with GMP, ALCOA+ data integrity... ...Contamination Control Strategy (CCS). Oversee contamination... ...Contribute to site readiness activities and...QualityFull timeTemporary workWork at officeLocal areaMonday to FridayShift workDay shiftKelly Services
Raleigh, NCa month ago- ...follow through.Position SummaryThe Director, Regulatory Affairs will serve as a U.S.-based regulatory strategy lead for assigned development... ..., and will contribute to high-quality, timely regulatory submissions... ...sound, submission-ready, and aligned with regulatory strategyPrepare...QualityWork at officeLocal areaRemote work
- QA Systems ManagerAt Guerbet, we build lasting relationships... ..., prognosis and quality of life of patients.... ..., safety, quality, and regulatory standards, and in... ...ANVISA, PIC/S), supports GMP operations, and drives... ...Supplier Quality and audit readiness. The incumbent will coach...QualityLocal area
- ...licensed CPA firm.Responsibilities· Lead regulatory compliance, BSA/AML, and fair lending... ...reporting· Oversee risk assessment, testing strategies, and documentation to ensure alignment... ...reports to ensure accuracy, consistency, and quality of deliverables· Communicate engagement...QualityFull timeContract workWork at officeFlexible hours
- ...doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC... ...functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products... ...requiredRepresent GRDRA during GMP inspections by... ...life cycle management of quality variations.Proficient...QualityHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
- POSITION SUMMARYThe Director, Quality Control provides strategic... ...with global GMP requirements.The Director... ...the overall control strategy. This role ensures inspection readiness data integrity, and continuous... ...with Manufacturing m QA, MSAT, AS&T, and Regulatory to support clinical...Quality
$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:...QualityLocal areaVisa sponsorship- Senior Manager, Regulatory Strategy (Labeling & Ad Promo)ICON is a global healthcare intelligence... ...labeling and ad promo services, balancing quality, timelines, and stakeholder... ...design (mock-ups, master/commercial/press ready, stability/validation), labeling/packaging...QualityFull time
- Protara Therapeutics is seeking a Senior Quality Specialist-Temp to provide QA support for GMP activities, review controlled documents, and strengthen... ...Management System. This role emphasizes data integrity, regulatory readiness, and cross-functional collaboration in a fast-...QualityTemporary work
$155.6k - $306.8k
...Summary Private Equity M&A Strategy & Diligence Manager Our... ...engagementManage development and quality review of client... ...rationalization, and buy-/sell-side readiness) with diligence capabilities... ...critical issues brought on by regulatory changes, competition, globalization...QualityOdd jobWork experience placementLocal area$189.2k - $372.9k
...Summary Private Equity M&A Strategy & Diligence Senior ManagerOur... ...messy data into crisp, IC-ready insights. You’ll drive... ...project workManage direct on-time, quality delivery of work... ...critical issues brought on by regulatory changes, competition, globalization...QualityOdd jobWork experience placementLocal area$138.6k - $257.4k
...Join Novartis as our QA Operations Head and play... ...patients receive high-quality medicines that meet... ...product quality, and regulatory compliance. As a visible... ...Ensure ongoing inspection readiness and successfully... ...Technical Operations strategy. Essential Requirements...Quality$163.4k - $322.1k
...technologies, and formulate consumer-driven strategies to engineer a digitally enabled,... ...analyses, insights, and high-quality, executive-ready deliverables grounded in research and... ...others The team An evolving customer and regulatory landscape, cost and operational pressures...QualityLocal areaFlexible hours- ...Turnover Specialist in Raleigh to ensure GMP documentation is complete, accurate, and inspection-ready. You will coordinate turnover to QA, resolve data discrepancies, and maintain... ...environments, a Life Sciences/Engineering/Quality background, and strong organizational and...Quality
$161.93k - $269.88k
...capabilities. The ideal candidate brings strategy and operations expertise, as well as AI... ...AssuranceDirectly align with enabling areas (e.g. PPN, Regulatory, Marketing & Comms, Sales Excellence) to... ...attention to detail and quality of work productAbility to build and sustain...QualityFull timeLocal areaVisa sponsorship- The Director, Clinical Quality Assurance is primarily responsible... ...the Clinical QA function and providing... ...and national regulatory requirements... ...overall global Quality strategy and initiatives.... ...inspection readiness plans and procedures... ...guideline, GCP, and GMP as defined by the...QualityTemporary workWorldwide
$95k - $145k
...complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based... ...skillsMeticulous attention to detail and quality of work productAbility to build and sustain...QualityRemote workVisa sponsorship- ...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...Quality
- ...seeking an experienced QA Consultant to help food... ...manufacturers meet FDA and GMP standards. The role... ..., FSMA compliance, and quality system development across... ...domestically. Strong regulatory knowledge and writing skills... ...and inspections readiness. #J-18808-Ljbffr Pace®...QualityRelief
- ...Senior Manager, Regulatory Strategy (Labeling & Ad Promo) ICON plc is a world-leading healthcare... ...labeling and ad promo services, balancing quality, timelines, and stakeholder... ...design (mock-ups, master/commercial/press ready, stability/validation), labeling/packaging...QualityRemote workFlexible hours
ICON plc
Raleigh, NC16 days ago - QA Program Manager Hybrid - 3 Days Onsite · Research... ...complex clinical and regulatory challenges. With deep... ...the Regulatory Affairs/Quality Assurance (QA) function... ...consultant on regulatory strategy matters. Lead risk... ...parental leave. If you are ready to be part of a team where...QualityContract work3 days per week
- ...a leading fertilizer company, seeks a Director of Regulatory Affairs - Biological & Traditional Fertilizers to lead global regulatory strategy, registrations, and compliance for bioscience... .... You will partner with R&D, legal, quality and commercial teams to enable market...Quality
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to GMP-Ready QA/RA Director Quality & Regulatory Strategy. Be the first to apply!
Related searches
- qa manager Raleigh, NC
- qa director Raleigh, NC
- quality assurance supervisor Raleigh, NC
- quality assurance manager Raleigh, NC
- quality assurance qa manager Raleigh, NC
- qa supervisor Raleigh, NC
- director quality assurance regulatory affairs Raleigh, NC
- quality manager healthcare Raleigh, NC
- quality manager Raleigh, NC
- director of quality & patient safety Raleigh, NC