A Quality R&D Third Party Senior Lead is needed for a leading pharmaceutical manufacturer in the Collegeville, PA area. This position manages quality oversight of external GMP service providers by assessing risks, ensuring regulatory compliance, and driving continuous improvement to support R&D project objectives.
location: Collegeville, Pennsylvania
job type: Contract
salary: $71.42 - 99.28 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Assess the current quality posture of external partners to identify key risks and required improvements.
- Identify and manage quality and compliance risks arising from projects.
- Design, develop, and implement third-party quality strategies for GMP service providers.
- Ensure external GMP providers comply with company quality standards, GxP regulations, and national health authority requirements.
- Provide GMP expertise and regulatory compliance advisory for selecting GMP suppliers for vaccine R&D projects.
- Performance manage project workstream activities and quality plans.
- Support business continuity by ensuring smooth internal and external site operations.
- Manage quality plans and project workstreams to maintain alignment with company objectives.
- strong knowledge of GMP principles and regulatory requirements.
- Proven project management skills.
- Experience in risk management and quality oversight.
- Knowledge of manufacturing and packaging processes.
- Understanding of PSC networks and supply capabilities.
- Excellent problem-solving and communication skills.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
