CrawlJobs Logo

Consultant: Clinical QA (GCP)

life-science-talent-solutions.dk Logo

Life Science Talent

Location Icon

Location:
Denmark

Category Icon
Category:
Research and Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

The consultant will assess the current “as-is” clinical QA/GCP and clinical safety oversight setup, identify gaps versus expectations, and implement remediation through pragmatic processes, governance, and SOP libraries. The goal is to elevate compliance maturity and ensure robust oversight of clinical activities and vendors, while strengthening readiness for audits and regulatory inspections.

Job Responsibility:

  • Quality oversight (GCP) across clinical delivery
  • Clinical Safety / PV quality interface
  • Gap assessment (“as-is”) and remediation plan
  • Build/upgrade SOP library and process framework
  • Audits, inspections, and readiness activities

Requirements:

  • Many years of experience in Clinical QA (senior-level capability
  • strong independence)
  • Specific QA GCP experience with demonstrated oversight responsibilities (not only operational execution)
  • Strong track record with audits and regulatory inspections (preparation and/or hosting/support)
  • Experience in rare disease programs and/or complex clinical settings
  • Experience in small biotech/lean organizations where the consultant can build structure without heavy bureaucracy
  • Ability to operate hands-on: building SOPs, setting up governance, and driving adoption

Nice to have:

  • Prior experience working closely with Clinical Safety/PV teams and vendors, including oversight and quality interface design
  • Broader GxP quality exposure (e.g., QMS build, quality risk management) if relevant to clinical scope

Additional Information:

Job Posted:
February 17, 2026

Employment Type:
Parttime
Work Type:
Remote work
Icon
Life Science Talent - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 31694 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Consultant: Clinical QA (GCP)

GCP QA Consultant

Are you a detail‑driven QA expert who's passionate about upholding exceptional G...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong background in clinical quality assurance and GCP compliance
  • Experience in reviewing and managing clinical trial documentation
  • Knowledge of regulatory inspection processes and risk-based quality management
  • Ability to lead audits and manage CAPAs effectively
  • Familiarity with oncology clinical trials is preferred
  • Excellent problem-solving skills and adaptability
  • Strong communication and collaboration abilities
Job Responsibility
Job Responsibility
  • Review key clinical trial documentation, including protocols, investigator brochures, informed consent forms, and trial master files
  • Lead assessments and investigations of quality issues, including root cause analysis, remediation, and timely resolution
  • Facilitate reviews of potential serious breaches and urgent safety measures for assigned clinical programs
  • Coordinate GCP-GVP vendor audits, manage audit programs, and ensure proper execution and closure of audits
  • Oversee quality management with functional lines and vendors, including leading Quality Oversight Committee meetings
  • Collaborate on implementing risk-based quality management (RBQM) strategies for studies, including critical data identification and reporting
  • Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis and strategy development
  • Provide guidance and training on compliance issues, leveraging expertise in GCP and industry best practices
  • Support the development, implementation, and maintenance of GCP standard operating procedures (SOPs)
Read More
Arrow Right

GCP QA Consultant

Proclinical is seeking a GCP QA Consultant to support quality assurance activiti...
Location
Location
Germany , Berlin
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong knowledge of ICH-GCP guidelines and regulatory requirements
  • Experience in quality assurance for clinical trials, particularly in phase 2-3 studies
  • Proficiency in risk management and quality oversight processes
  • Ability to manage and maintain TMF documentation and ensure inspection readiness
  • Skilled in identifying deviations, implementing corrective actions, and driving process improvements
  • Excellent communication and collaboration skills to work with cross-functional teams and external partners
  • Familiarity with Clinical Trial Agreements, site feasibility, and activation processes
  • Leadership and mentoring abilities to guide junior team members
Job Responsibility
Job Responsibility
  • Develop and oversee study quality-related plans, including Oversight Quality and Audit Plans
  • Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas
  • Oversee quality activities for phase 2-3 trials, focusing on risk management and endpoint de-risking
  • Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements
  • Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings
  • Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements
  • Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events
  • Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans
  • Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes
  • Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready
  • Fulltime
Read More
Arrow Right

Cqa

Location
Location
China , Shanghai
Salary
Salary:
360000.00 - 480000.00 CNY / Year
https://www.randstad.com Logo
Randstad
Expiration Date
June 03, 2026
Flip Icon
Requirements
Requirements
  • Bachelor's degree or above in life sciences or related fields
  • Master's degree or higher preferred
  • At least 5 years of clinical research experience, including at least 2 years focused on GCP quality assurance/compliance
  • Experience in GCP management (including root cause analysis) and hands-on support for regulatory GCP inspections
  • Proficient in NMPA, FDA, and EMA clinical research regulations and ICH-GCP guidelines
  • familiar with global multi-regional regulatory requirements
  • Ability to independently develop study quality management plans and audit protocols and lead their implementation
  • Excellent communication and coordination skills, capable of building effective internal and external partnerships and guiding clinical teams to focus on quality
  • Adaptable to a fast-paced, multi-tasking, and dynamic startup environment, able to meet tight deadlines
  • Fluent in English, capable of using it as a working language
Job Responsibility
Job Responsibility
  • Develop, implement, and maintain clinical SOPs, policies, work instructions, and templates
  • Ensure SOPs align with global regulatory requirements (e.g., FDA, EMA, ICH GCP, MHRA)
  • Manage SOP lifecycle activities including authorship, review, approval, training, and periodic review
  • Provide QA oversight for clinical trials conducted by CROs, vendors, and investigative sites
  • Support risk-based quality management (RBQM) activities, including quality risk assessments and mitigation plans
  • Review clinical trial documents (e.g., protocols, ICFs, monitoring plans, vendor plans) for quality and compliance
  • Plan, conduct, and manage internal audits, vendor audits, and investigator site audits
  • Support regulatory inspections (e.g., FDA, EMA, MHRA, NMPA), including inspection readiness, hosting, and follow-up
  • Track and manage audit findings, CAPAs, and effectiveness checks
  • Oversee deviation, noncompliance, and issue management processes
Read More
Arrow Right

Clinical Research Coordinator IV

PURPOSE AND SCOPE: Works under the supervision of the Principal Investigator (PI...
Location
Location
United States of America , Denver
Salary
Salary:
Not provided
freseniuskidneycare.com Logo
Fresenius Kidney Care Eupora
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree
  • Advanced Degree preferred or an equivalent combination of education and experience
  • Has excelled in the role of Clinical Research Coordinator III or equivalent for 5+ years and demonstrated a mastery of the job role, outstanding performance, and exceptional job performance measures
  • Clinical research site experience required
  • Clinical Research Coordinator certification (e.g., CCRC or CCRP) required
  • Current state licensure, if applicable
  • Excellent computer skills: Ability to adapt to various electronic systems
  • proficiency in Microsoft Office applications minimally
  • Excellent communication and organizational skills
  • Training/experience in management or other leadership roles is desirable
Job Responsibility
Job Responsibility
  • Works under the supervision of the Principal Investigator (PI) to support the conduct and management of a clinical study by facilitating and coordinating the daily study activities
  • Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines
  • Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source
  • Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations
  • Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Food and Drug Administration (FDA) guidelines
  • Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies
  • Complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal regulations
  • Adheres to Standard Operating Procedures (SOP), GCP, all regulatory practices as established by law, and company policies and procedures
  • Maintains essential trial documents according to applicable HIPAA and regulatory requirements
  • Works with dialysis facility manager and/or clinic manager to master standard of care procedures to better advocate on behalf of site research capabilities
What we offer
What we offer
  • Healthcare
  • Continuing Education
  • Paid Time Off
  • Collaborative Environment
  • Additional Perks
  • 401(k) Retirement Saving
  • Fulltime
Read More
Arrow Right
New

Senior Lecturer/Associate Professor in Literacy

As a Senior Lecturer / Associate Professor in Literacy, you will play a key role...
Location
Location
Australia , Albury-Wodonga, Bathurst, Port Macquarie, Wagga Wagga
Salary
Salary:
Not provided
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 08, 2026
Flip Icon
Requirements
Requirements
  • A doctoral qualification relevant to literacy or education, with a recognised teaching qualification
  • A strong record of high-quality teaching and student-centred learning
  • An established or emerging research profile aligned to literacy, curriculum or pedagogy
  • The ability to build productive partnerships and contribute to academic leadership
Job Responsibility
Job Responsibility
  • Lead impactful literacy teaching and research
  • Teach across online and on-campus environments
  • Shape future teachers and education practice
  • Contribute to curriculum innovation
  • Build strong relationships with students and partners
  • Provide academic leadership in literacy education
  • Contribute to the School's research profile
  • Supervise higher degree research students
  • Actively engage with professional, community and government stakeholders
  • At Associate Professor level: significant academic leadership, research impact, and contribution to the broader discipline at national/international level
What we offer
What we offer
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Program Manager - Controls and Avionics Solutions

This position is based in Endicott, New York. New York and on-site work will be ...
Location
Location
United States , Endicott
Salary
Salary:
120874.00 - 205486.00 USD / Year
baesystems.com Logo
Baesystems
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in engineering, engineering or manufacturing management, or other discipline
  • Demonstrated ability for building strong customer/ stakeholder relationships
  • Strong communication, negotiation, and presentation skills
  • Ability to interpret data and make data-driven decisions
  • Highly adaptable with strong initiative
  • Demonstrated ability to lead and motivate cross-functional teams
  • Knowledge of the global aviation market and regulatory requirements and/ or military aviation market
Job Responsibility
Job Responsibility
  • Maintaining strong customer relationships and leading a multidisciplinary team to execute complex development programs within schedule and budget
  • Leadership and management oversight of a project team assuring that project’s financials, schedule, and technical objectives are met and that the highest level of customer satisfaction is achieved while meeting all contractual commitments
  • Work effectively and collaboratively with Engineering, Operations, and all Program Office functional leadership to assure deliveries continue to exceed customer commitments and achievement of financial commitments to the company
  • Manages, coordinates, plans, organizes, controls, integrates, and executes projects within the Military Aircraft Systems portfolio
  • Participates in the support of new business and in the development of proposals
What we offer
What we offer
  • Health insurance
  • Dental insurance
  • Vision insurance
  • Health savings accounts
  • 401(k) savings plan
  • Disability coverage
  • Life and accident insurance
  • Employee assistance program
  • Legal plan
  • Discounts on home, auto, and pet insurance
  • Fulltime
Read More
Arrow Right
New

Finance Business Partner (Research)

Full Time, Fixed Term (12 months). Level 7 - $101,421 to $110,819 p.a. (plus 17%...
Location
Location
Australia , Wagga Wagga
Salary
Salary:
101421.00 - 110819.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 02, 2026
Flip Icon
Requirements
Requirements
  • A degree in Accounting or Finance (professional accounting body membership is desirable)
  • Experience in project budgeting, forecasting and financial analysis
  • Background in management accounting or business partnering within complex environments
  • exposure to government funding or higher education is advantageous
  • Excellent stakeholder engagement skills, with the ability to work effectively with academics and researchers
  • Familiarity with business intelligence systems and dashboard reporting
Job Responsibility
Job Responsibility
  • Partner with academics to deliver strategic financial insights that enable research success
  • Directly influence world-class projects and decisions shaping the future of education and innovation
  • Lead initiatives that enhance financial governance, deliver accurate and timely reporting, and support key projects such as cost-pricing systems and research budgeting
  • Help build financial capability across the University, fostering collaboration and continuous improvement
What we offer
What we offer
  • Flexibility with a 35-hour work week
  • Access to hybrid work arrangements
  • 17% superannuation
  • Fulltime
Read More
Arrow Right
New

Associate Lecturer/ Lecturer in Oral Health

Make a real impact by educating future oral health professionals to serve the ur...
Location
Location
Australia , Wagga Wagga
Salary
Salary:
80046.00 - 134965.00 AUD / Year
csu.edu.au Logo
Charles Sturt University
Expiration Date
June 16, 2026
Flip Icon
Requirements
Requirements
  • A qualification relevant to the discipline and appropriate to the level being applied for
  • Full registration (for teaching/research) as a Dentist or Oral Health Therapist with the Australian Health Practitioner Regulation Agency (Ahpra)
  • Excellent understanding of the clinical practice of oral health therapy, supported by a record of teaching and subject coordination relevant to the discipline and appropriate to the level being applied for
  • Evidence of the delivery of high quality student-centred learning and teaching in oral health therapy and/or general dentistry
  • A record of research activity or capability relevant to the discipline and appropriate to the level being applied for, as outlined in the position descriptions, may facilitate the progression of research opportunities
Job Responsibility
Job Responsibility
  • deliver high-quality teaching, clinical supervision and learning experiences in Oral Health
  • work with students in both clinical and preclinical settings while contributing to curriculum development, industry engagement and community partnerships
What we offer
What we offer
  • Generous support provided to assist with relocating to Riverina’s beautiful Wagga Wagga or surrounds
  • 17% superannuation
  • Fulltime
Read More
Arrow Right