Clinical Quality Assurance Lead – 18 month Fixed Term Contract

Clinical QA Lead (18‑Month Fixed Term Maternity Cover)

ProPharma is seeking an experienced Clinical Quality Assurance Lead to join our global QA team. The role will provide guidance for quality activities and drive continuous improvement across our Clinical Research Solutions (CRS) and Functional Service Provider (FSP) service lines.

Responsibilities

• Host and support CRS/FSP client audits and regulatory authority inspections, including preparation, conduct, and reporting.
• Serve as subject‑matter expert for applicable quality topics, CAPA review and approval, and eQMS record management.
• Develop and track CAPA responses arising from client and inspection activities.
• Collaborate with multiple business lines to prepare for and conduct audits and inspections.
• Coordinate Client Questionnaire Audits and serve as SME for quality topics.
• Review and approve Deviations, Quality Events, CAPAs, and Effectiveness Checks in the eQMS.
• Support project leadership in setting up and subscribing to client‑specific Deviation, Quality Event, and CAPA eQMS reports.
• Conduct periodic review of eQMS reports to identify emerging trends.
• Escalate emerging trends to management for improvement opportunities.
• Perform GxP change‑management activities, including risk/impact analysis, change plan review, approval, and implementation.
• Provide ongoing GxP SME to CRS/FSP staff.
• Participate in CRS/FSP client operational meetings requiring CQA representation.
• Contribute to the creation and approval of controlled documents such as SOPs and work instructions.
• Review and approve CRS/FSP and QA controlled documents and computerized‑system validation documentation in the eQMS.
• Identify and report potential service‑impacting issues to management with corrective actions.
• Support the internal QA program, including quality assurance and quality control activities.
• Maintain adherence to applicable SOPs, GxP regulations, and client agreements.

Qualifications

• Advanced computer skills with Microsoft Office and Adobe Acrobat.
• Experience with GxP QMS, including record management, reporting, and data analysis.
• Willingness to train staff on eQMS fundamentals.
• Strong communication skills to translate quality issues to non‑quality staff.
• Excellent verbal, written, and presentation skills and ability to build professional relationships.
• Analytical mindset to evaluate and troubleshoot complex problems.
• Highly responsible, self‑motivated, and enthusiastic about GxP work.
• Exceptional time management, project coordination, and problem‑solving skills.
• Attention to detail and commitment to quality.
• Ability to handle stressful situations and adapt to changing priorities.
• Willing to travel 5 % of the time, including internationally.
• Fluent in English (speaking and writing).
• University or bachelor’s degree (or equivalent experience).
• At least 5 years of quality experience in pharmaceutical, medical device, or other regulated industries.
• Minimum 2 years of hosting GCP audits.
• Prior CRO experience is preferred.

Additional Information

Travel: 5 % of time, including international travel.

Equal Opportunity Employer

We celebrate our differences and create a workplace where every employee can be authentic. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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