What are the responsibilities and job description for the Quality R&D Lead position at Proclinical Staffing?
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.
