myGwork - LGBTQ+ Business Community · 3 days ago

R & D 3rd Party Senior Director

King of Prussia, PA

Full-time

Onsite

Director

10+ years exp

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Responsibilities

Lead the Quality R&D quality management of Third Parties involved in all outsourced manufacturing, analytical and distribution process steps from development to commit to phase III clinical vaccines and medicines.

Provide quality leadership to the incoming material suppliers and supplier network for externally supplied to the R&D GSK manufacturing sites, chemicals and components.

Accountable for setting the strategy, inspiring and motivating the team, priority planning, and making high-impact risk-based decisions.

Responsible for operational quality activities including due diligence, quality agreements, joint quality governance, compliance frameworks, audit and regulatory inspections support, remediation facilitation, submissions review, launch preparation, and quality systems implementation.

Detect, escalate, and mitigate risks within the area of R&D Third Party Quality.

Manage and drive quality improvement of R&D external network for small molecule, large molecule, and vaccine.

Ensure inspection readiness for the approval of new R&D CMO's.

Empower, support, and coach the team to drive improvements in ways of working.

Oversee and manage significant deviations, change control, and customer incidents for R&D incoming material suppliers and CMO.

Influence R&D functional partners and Quality R&D leadership team to ensure high-quality standards and systems are in place to support manufacturing process and distribution of clinical contracted activities.

Engage internal and external stakeholders to embed a fit-for-purpose quality mindset across Business Owners and Third Parties.

Ensure compliance with all training requirements and manage the budget according to GSK Finance guidelines.

Ensure compliance with cGMP, policies, and procedures.

Deliver required actions through training in site systems and QMS.

Qualification

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Quality managementLeadershipProject managementContinuous improvementDecision makingProblem solvingCommunicationR&D StandardsQA ReleaseGCP/GLP AuditingQuality ControlProblem-Solving

Required

Minimum Level of Education BA/BS degree or equivalent in experience - Area of Specialisation Scientific or engineering degree.

Experience required 10 years' experience in Quality function in a highly regulated environment. Proven record of accomplishment regarding Leadership, Project Management, Continuous Improvement, Decision Making, Problem Solving, and Communication.