Full Description

Overview

Job Description Summary

Provide leadership in formulating regulation policy including resource management and development, implementation, and maintenance of a Quality Management Program for the Phase 1/2A IND, Biologics and Good Tissue Practice programs. Lead quality input in process development IND manufacturing and quality control of biologics manufacturing program. Manage under the direction of the Director of Research Compliance & Integrity the implementation of quality management systems in relation to Quality Assurance in order to ensure product safety and regulatory compliance.

Job Description

Essential Functions

Establish and maintain appropriate quality system to ensure compliance with regulatory requirements. Register, distribute and maintain controlled documents including but not limited to Quality Management Plan, Batch Record Documents, Standard Operating Procedures (SOPs), Master Validation Plans, Validation Protocols and Quality Assurance Manual. Represent the Biologics Manufacturing Facility during client and regulatory inspections. Represent the Research Institute (RI) during regulatory inspections. Ensure that requirements for quality systems are met according to FDA guidelines and industry standards for the manufacture of biologics and an overall program for Good Tissue Practices. Work closely with the Scientists, Biologics and Facility Management Teams for deviation investigations, process change controls and implementation of process improvement changes. Perform internal and external audits to ensure compliance with regulatory and internal guidelines. Provide cGMP training to staff on a continuing basis. Provide oversight to product development including raw material technical specifications and supplier selection. Approve and release product (investigational drug/device) for use in clinical trials and as appropriate to Good Tissue Practices. Assign and delegate responsibilities to Biologics QA Auditors. Develop and collaborate with Biologics Manufacturing Leadership on continuous improvement and CAPA projects.

Education Requirement

Requires a MS degree in a scientific discipline or equivalent experience.

Licensure Requirement

(not specified)

Certifications

(not specified)

Skills

Knowledge and expertise in the principles of current Good Manufacturing Practices. Strong technical documentation and auditing skills with the ability to work with complex details. Experience with cGMP practices relative to biological products and cell cultures.

Experience

Minimum of five years of successful quality and regulatory experience.

Physical Requirements

Note frequency as Constantly (67-100%), Frequently (34-66%) and Occasionally (0-33%) for each requirement. Also note any lifting requirements with pound limit.

Sitting - Constantly

Stooping - Occasionally

Standing - Occasionally

Talking on the phone or in person – Frequently

Walking – Occasionally

Additional Physical Requirements Performed But Not Listed Above

(not specified)

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"