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Quality R&D Lead - Contract - Collegeville PA

À±½·ÊÓƵ 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

À±½·ÊÓƵ is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

À±½·ÊÓƵ Staffing is an equal opportunity employer.