Research Biologics Quality Assurance Manager BioMnf

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"