Associate Director, Quality Compliance
Oversee the global compliance function and related processes within the range of laboratory, clinical, manufacturing and distribution operations. Provide direction to Compliance staff, ensuring that compliance activities achieve an inspection readiness status in the cGMP and GxP environments and are in compliance with Company policies, procedures, standards and applicable local, state, federal, and international regulations governing drug products and medical devices.
Leader of Quality Compliance team driving functional excellence and tactical execution of GxP and Pharmacovigilance programs and procedures.
Oversees the support activities for all regulatory audit processes relating to GxP including, but not limited to, FDA, MHRA, EMA and Health Canada. Provides corporate training on inspection readiness and best practices.
Assures research and development work activities are compliant with all appropriate regulatory requirements (GCP / GLP). Supports GCP / GLP activities by planning and effectively managing the implementation of audits, both internal to research and development clinical work and external to investigators.
Oversees the Product Complaint process managing the investigation, identification of trends, escalation of critical issues and the timely closure of product complaints.
Collaborates with Pharmacovigilance (PV) to ensure Adverse Event / Complaint management are executed in a timely manner.
Manages the Field Action and Product Recall processes including the development and maintenance of procedures associated with these processes.
Manages the Annual Product Quality Reports (APQR) to ensure accurate and timely completion of required documents.
Oversees and executes the self-inspection audit program for all GxP areas to assure compliance with policies procedures and regulatory requirements. Works with functional owners to drive corrective actions and ensure the effectiveness of responses. Creates metrics to improve the performance of the self-inspection process.
Oversees the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and communication of results expediently to applicable groups.
Conducts ongoing surveillance of world-wide regulations, agency guidance documents, industry standards, new technologies and internal needs. Works with functional owners to ensure updates to procedures and policies to comply with the ever-changing regulatory environment.
Working hours: 8:00 AM - 5:00 PM
BS/BA degree in a related medical, science or business discipline or equivalent training and formal experience; minimum 7+ years' experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries.
Functional quality expertise in pharmaceutical regulatory compliance (cGMP) is required.
Strong knowledge of clinical compliance GCP and GLP is desired.
Advanced computer skills, data reporting and quality analyst capabilities are a plus (Excel / CatsWeb / Visual Basic / SQL / Web Development).
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