OBJECTIVE

This position will provide the appropriate quality leadership and strategic input to develop, operate and maintain quality systems in support of contract development and production of novel cell based and biological therapies.

ESSENTIAL DUTIES/RESPONSBILITIES

1. Responsible for ensuring that personnel, methods, corporate policies and SOPs comply with local, state, federal and global requirements, regulations, GLP, GTP and GMP requirements.

2. Responsible for overseeing the planning, creation, implementation and control of a quality system established to ensure product reliability, quality, efficacy, compliance to applicable regulations, GMP, GLP, GTP and internal standards for manufacturing, material and finished product.

3. Oversee the management of the controlled document system including standard operating procedures, specifications, and batch production records.

4. Oversee the establishment of qualifications and validate standards for new products and procedures.

5. Create, implement and maintain a compliance auditing program to fulfill regulatory requirements.

6. Identify critical operation issues including quality, regulatory and resource issues that impact production projects.   

7. Responsible for collaborating with Regulatory/Materials Management/Manufacturing functions to ensure all production processes comply with cGMPs.

8. Identify quality improvement needs and opportunities and ensure that appropriate personnel address the issue(s).

9. Provide guidance to effectively resolve deviations and out-of-specification results and work closely with QC/Manufacturing to develop plans for investigations and corrective actions.

10. Actively participate in completed batch production review.

11. Ensure that corrective actions are implemented.

12. Assist in the development and maintenance of training programs throughout the Company.

13. Hire, train, and manage all quality staff to achieve department/organization goals.  Staff will be trained to the expected standards adopted by the Company.

14. Assess employee performance requirements and evaluate achievement of specific goals.

15. Coordinate quarterly reports and/or updates as they relate to quality activities and completion of projects.

16. Design and review/approve SOPs, test procedures, validation procedures, etc.

17. Frequently interacts with subordinate supervisors, outside customers, and functional peer group managers.

18. Carry out managerial responsibilities in accordance with the organization’s policies, procedures and state, federal and local laws.

QUALIFICATIONS

Bachelor’s degree in science or related life sciences field.   Must have 8 plus years supervisory/management experience in a biotechnology or related company.  Must of 6 plus years experience in a quality position.  Experience in a Cellular Therapy Company preferable.

The candidate must also have the following:

- a thorough knowledge of cGMP, GTP, GLP, and principles of QA/QC.

- strong knowledge of FDA quality systems regulations, qualifications and validation requirements.

- experience in writing protocols, reports and compilation of documents required for regulatory submissions.

- strong management and training skills.

- detail oriented and have excellent organizational skills.

- able to work in multi-faceted operation.

- ability to drive projects to completion under pressure.

- strong interpersonal, communication and technical writing skills.

- ability to manage and organize time effectively.

SUPERVISORY RESPONSIBILITY (if applicable)

Individual will oversee Quality Assurance  operations.