BioSpace · 2 days ago

Head, R&D Quality

King of Prussia, PA

Full-time

Onsite

Executive

10+ years exp

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Comp. & Benefits

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Responsibilities

To establish and maintain quality systems, standards, and procedures for new and lifecycle development products.

Provide direction and oversight of the Quality Management System for Clinical, Combination Products/Medical Devices, Pharmacovigilance, and Safety.

Lead and co-ordinate internal and Health Authority inspections.

Accountable for Quality interfaces from early phase research to GMP manufacture and commercial launch.

Chair senior R&D Quality Management Review and participate in key R&D Governance bodies.

Define and manage the process for Quality supplier qualification of vendors contracted by R&D.

Educate R&D resources on quality requirements across the product development lifecycle.

Qualification

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R&DClinical OperationsClinical SupplyPharmacovigilanceGMP QualityHealth Authority InspectionsMatrix OrganizationProblem-SolvingCommunicationInfluencingCross-Cultural Experience

Required

Requires a degree in a scientific, engineering or related discipline. Post graduate qualifications (Masters/PhD) are preferred.

Requires minimum of 10 years of experience with equal exposure to both R&D and Quality in R&D. Quality experience should include audit participation at some level.

Understanding of R&D clinical operations, clinical supply and Pharmacovigilance is essential.

Experience of GMP Quality is also valuable.

Knowledge and experience of leading Health Authority inspections.

Must be comfortable working in a global, matrix organization with cross-cultural experience.

Experienced at communicating and influencing at senior and executive management level.