Quality R&D Lead - Contract - Collegeville PA

Proclinical is seeking a Quality Integration Specialist to support the assessment and integration of quality plans for external partners.

Primary Responsibilities:

This role focuses on developing third-party quality strategies and ensuring compliance with data integrity, GxP regulations, and national health authority requirements. You will play a key role in promoting a culture of quality and safety while providing GMP expertise and regulatory compliance advice.

Skills & Requirements:

Understanding of GMP and project management skills.Experience in risk management and manufacturing processes.Problem-solving abilities and excellent communication skills.

The Quality R&D Lead's responsibilities will be:

Assess the quality posture of external partners to identify risks and improvement needs.Oversee operational quality activities, including deviations, change controls, CAPAs, and batch release for drug substances and products.Manage project workstream activities and escalate compliance issues as needed.Build relationships with cross-functional teams and stakeholders.Manage quality plans for projects to ensure business continuity.Encourage collaboration for cross-functional input on key decisions.Identify and manage quality and compliance risks from projects.Drive continuous improvement in processes, value creation, and cost savings.Implement robust root cause analysis and problem-solving tools.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.