Senior Quality Assurance Manager

BioAgilytix Labs is a contract bioanalytical laboratory whose mission is the complete satisfaction of their pharma, biotech and agriculture clients’ needs in the discovery, GLP, GCP/GCLP and GMP areas for studies such as: (1) immunoassays, (2) pharmacokinetics, (3) immunogenicity, (4) biomarker analysis and (5) cell-based assays measuring downstream targets of small and large molecule drugs.

Position Description:

The principal responsibilities for this position are to:

• Manage all direct reports (all level of auditors)
• Develop, implement and manage QA systems as detailed in the QMS, conduct periodic reviews of QMS, and implement corrective actions.
• Lead/performs protocol, data, report, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOP, protocols and regulatory requirements.

• Write QA SOPS and provide regulatory input for other department SOPs

• Assist or host sponsor audits and government agency inspections
• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
• Notifies management of quality/compliance trends and service failures.
• Monitor regulatory and industry trends/actions and report regularly to QA management.

• Interface with internal departments, external customers and regulatory entities regarding compliance needs, issues and status.

• Supports maintenance of the Master Schedule for nonclinical studies

• Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks.

Requirements:

• BS degree in biology, chemistry, or other scientific or related field
• Minimum of 8 years of experience in a Quality environment, with a minimum of 2-3 years of management experience
• Extensive knowledge of GxP Regulations with a minimum of 5 years working in a GLP, GCP or GMP environment.
• Experience in evaluation GxP systems and processes to ensure compliance with regulatory requirements and in assessment of GxP quality systems
• Extensive Internal and/or external GxP auditing experience
• Experience in hosting government agency and Sponsor inspections
• Ability to work in a fast paced environment where multiple projects are in process and must be completed in a timely manner under minimal supervision
• Excellent oral and written communication skills are essential
• Proficient use of computer and Microsoft software programs

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