Manager, Quality Assurance
Manages and coordinates daily duties and provide opportunities for training and development of the Quality Assurance (QA) Specialists. Monitor and maintain compliance with current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR), Points to Consider (PTC), International Conference on Harmonisation (ICH), Good Laboratory Practices (GLP), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Solicit and implement industry best practices.
· Supervises, plans and reviews operations for assigned staff, including coordinating, scheduling and assigning work and maintaining facility's standards.
· Responsible for new hire employee training, employee development/guidance and conducting employee performance appraisals in a timely and objective manner.
· Keeps team current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
· Keeps the department current with regard to the practice of all appropriate cGMP, CFR, PTC, ICH and relevant foreign regulatory guidelines.
· Interfaces with company’s internal departments, clients, FDA and other appropriate regulatory officials on QA / regulatory matters.
· Leads/Participates in client audits and responds to audit findings in a timely manner. Supports and actively participates in regulatory inspections.
· Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements. Focus on driving continuous quality improvements. Initiates and revise SOPs and Policies as necessary.
· Perform trend analysis, report results and coordinate corrective and preventative actions (CAPA) to drive compliance and quality initiatives. Measure, track and evaluate key quality metrices to support future quality initiatives and resource allocation.
· Lead and/or participates on cross-functional teams and projects representing quality in positive and compliant manner.
· Manages and conducts documentation review and approval including but not limited to: Testing and Manufacturing Batch Records, Cleaning Record, Client Protocols, Training Records, Qualification/Validation Documents, subcontractor reports, raw material receipt records, equipment charts and records, final reports, Certificate of Analysis (CofA), and SOPs.
· Review, approve and perform investigations and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills.
· Supports QA aspects of the change control processes (equipment, facilities, utilities and document) and ensure are handled in a compliant manner
- Must have 5 or more years experience managing personnel
- Strong knowledge of cGMP, GLP requirements, PTC guidelines and ISO17025
- Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
- Ability to evaluate technical data and to assist in the writing and editing of technical documents.
- Ability to use judgment, clear problem-solving and decision-making skills.
- Ability to work under limited supervision and to handle complex problems.
- Ability to communicate effectively with all levels of the organization.