Assists in establishing current quality systems as they pertain to current industry, regulatory and customer requirements for investigational new drugs, biologics and/or medical devices and maintaining operations in a state of control. Also assists the QA Director in maintaining the established systems. 

• Establishes Standard Operating Procedures (SOP), performs routine maintenance of SOPs, including periodic reviews to assure alignment of systems with regulatory requirements and global requirements. Provides training when required to assure retention. 

• Audits departments for compliance to the quality systems, generating audit reports, identifying trends, and establishing performance of the quality system  

• Provides quality oversight of vendor qualifications, i.e. questionnaires, quality agreements, vendor audit schedule etc.  

• Maintains Change Control, Deviation, Out of Specification, Corrective and Preventative Action, Complaint and investigation report system and follow-up actions. 

• Assists in maintaining compliance status of the facility and audit readiness.  

• Implements quality compliance and corrective action training. 

• Trains new employees and junior team members on TFS procedures and cGMP regulations. 

• Works independently on projects as Quality Assurance Representative with no supervision. 

• Maintains current knowledge of ICH requirements to assure compliance of Quality systems.  

• Responsible for ensuring that all APQR’s are properly generated, reviewed, and submitted. 

• Partner with site (Logistics and Quality Assurance) and network resources to provide oversight of supplier management and site-specific supplier quality issues.  

• Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects to enhance client satisfaction.

• Other assignments and tasks as required.

REQUIREMENTS:

• Advanced Degree plus 2 years of experience, or Bachelor's Degree in Chemistry, Biology, or related scientific discipline plus 5 years of experience.

• Excellent project management and problem-solving abilities

• Strong written and verbal communication skills in English

• Ability to work independently and collaborate effectively in a matrix environment

• Proven track record of building relationships with suppliers and interdepartmental groups