Alphanumeric is hiring a QUALITY R&D THIRD PARTY SENIOR LEAD to work in Upper Providence, Collegeville, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Pay Range:
This position is responsible for supporting the assessment and Quality integration plan relating to integration of assets.
Responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP services provided to R&D to ensure that external providers of critical services (CMOs) comply with data integrity and quality standards, GxP regulations and meet national health authority requirements.
Promote and implement a Quality and Safety culture within R&D.
Provide business owners and third parties with GMP expertise and regulatory compliance advisory and act as a valuable source to R&D for the selection of GMP suppliers for vaccine R&D projects allocated, while promoting operational efficiency, continuous improvement and contributing to R&D pipeline acceleration.
Key Responsibilities:
* Assess the current Quality Posture of External Partners to identify any key risks or required Quality Improvement activities
* Perform Operational Quality oversight of Third Parties, including Deviations, Change Controls, CAPAs and Batch Release Activities for Drug Substance and Drug Product.
* Performance management of project workstream activities
* Escalate serious cGMP/Regulatory compliance issues following internal procedures
* Building relationships with cross functional team and stakeholders
* Performance manage quality plans for projects
* Ensure business continuity in a changing environment, supporting sites internal / external
* Encourage collaboration across the company to ensure cross-functional input to key decisions and initiatives
* Identify and manage Quality and Compliance risks that arise from projects
* Proactively drive a mindset of continuous improvement of processes, value creation and costs savings without compromising compliance, quality or customer service across the team
* Drive robust RCA and problem solving mindset and use of tools across organisation and ensuring CAPAs are implemented to address root causes