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