Quality Assurance Manager
Reporting to the Director of Quality Assurance, the QA Manager has the overall responsibility for maintaining as well at enhancing the Quality Systems and providing support for standardization of procedures within the company for the assigned site/s in collaboration with QA Management. The position will oversee and manage Quality Assurance activities, ensuring GLP, GCP, Quality Processes, Training and Qualification. She/he is also responsible for conducting and or scheduling internal (Facility, Study-Specific) and hosting external audits to assess compliance with regulations, and company procedures. In addition, she/he will serve as the Quality/GxP resource for supporting project teams at the assigned site/s in collaboration with QA Management.
- Develop, implements, maintains and enhances Quality Systems and associated procedures; Involved in obtaining appropriate certification or accreditation (e.g. CAP, CLIA, GLP) as needed;
- Updates and maintain Quality Assurance logs, databases, and generate metrics as needed;
- Ensures Vendor audits are scheduled and conducted as required,
- Provides GxP compliance, general QA support and guidance to personnel;
- Schedules and conducts internal (Facility, Study-Specific) and external audits;
- Reviews SOPs to ensure compliance with applicable regulatory and corporate standards;
- Develops and writes QA SOPs;
- Participates in the development and delivery of internal quality and regulatory training programs;
- Assists management in the preparation for regulatory agency inspections and sponsor specific inspections;
- Reviews and evaluates investigations, findings and resolutions, change control, CAPAs, non-conformances, and audit observations;
- Reviews CAPAs to determine effectiveness, performs trend analysis and compile summary reports;
- Recruitment and management of any QA auditors as required;
- Ensures harmonization of QA audits and findings within site/s and company requirements.
- Keeps up to date with current regulatory guidelines and regulations;
- Communicates compliance risks to senior management;
- Performs/coordinate audits for equipment and software validations;
- Performs other duties as assigned.
Required Expertise and Skills
- Bachelor's degree;
- 5+ years of quality and/or compliance related experience in CRO industry, working in a regulated environment with direct QA responsibility and staff management;
- Knowledge, understanding, and application of ISO/IEC 15189, GCP, EMA, OECD in relation to Good Laboratory Practice (GLP) and/or GCLP quality requirements;
- Knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance, applied to various bioanalysis techniques (e.g. Immunoassays, Quantitation, etc.);
- Demonstrate documentation management skills, ability to design and implement quality processes;
- Strong commitment to the accomplishment of tasks, self-motivated, excellent organizational skills;
- Proven flexibility to adjust to constantly changing priorities, handle multiple tasks, while maintaining quality;
- High level of attention to detail and accuracy, excellent investigative techniques;
- Ability to work well in a team environment;
- Strong leadership, team management and communication skills;
- Ability to identify and/or resolve quality issues, discrepancies with others in a proactive, diplomatic, flexible and constructive manner;
- Be able to independently convey information with authority, handle highly sensitive matters and interact with high-level contact with other organizations.