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Clinical Quality Assurance Lead (GCP) - CEE
Job Description
Exciting Opportunity: Clinical Quality Assurance Lead (GCP) – Central & Eastern Europe (CEE) – Remote
Are you a dedicated quality professional with a passion for ensuring the highest standards in clinical research? We are seeking a proactive and detail-oriented Clinical Quality Assurance Lead specialized in GCP to join our dynamic team supporting the healthcare and pharmaceutical industries across CEE. This is a critical role that offers the chance to influence compliance excellence in a fully remote setting, with minimal travel, and to work on impactful projects for a leading organization.
In this hands-on leadership position, you will serve as a key quality expert, guiding audits, regulatory inspections, and process improvements. Your expertise will directly support our clients’ success and ensure our clinical operations meet rigorous GxP standards. If you are ready to make an immediate impact and thrive in a collaborative, fast-paced environment, we want to hear from you.
Required Skills:
- Minimum of 2 years' experience leading GCP audits within a clinical or pharmaceutical setting.
- Proven expertise in GxP quality management systems, including audit preparation, conduct, reporting, and CAPA management.
- Strong understanding of regulatory compliance, GCP guidelines, and inspection readiness.
- Excellent written and verbal communication skills in English with the ability to articulate quality issues clearly.
- Proficiency with Microsoft Office Suite and Adobe Acrobat.
- Exceptional attention to detail, problem-solving skills, and the ability to prioritize multiple tasks.
- Ability to work independently in a remote environment and collaborate effectively with cross-functional teams.
- Willingness to travel at least 5%, including internationally.
Nice to Have Skills:
- Previous experience in a Clinical Research Organization (CRO) setting.
- Knowledge of computerized systems validation and quality documentation.
- Experience preparing for and hosting client audits and regulatory inspections.
- Familiarity with quality management system software (eQMS).
- Additional language skills relevant to the CEE region.
Preferred Education and Experience:
- Bachelor’s degree in a related field or equivalent work experience in the pharmaceutical, biotech, or healthcare industry.
- At least 5 years of quality assurance experience in regulated environments, with a strong focus on clinical trials and GCP compliance.
- Demonstrated experience in a lead or audit capacity, supporting inspections and regulatory queries.
Other Requirements:
- Ability to adapt to fluctuating business needs and prioritize effectively.
- Flexibility to travel internationally, approximately 5% of the time.
- Urgent availability desired, with the ability to start promptly.
- Commitment to maintaining confidentiality and the highest professional standards.
Take the next step in your career by joining a global organization committed to improving healthcare outcomes. Apply now and be part of a team that values expertise, initiative, and a passion for quality excellence. Your expertise can make a real difference in advancing innovative therapies and patient care worldwide.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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