Quality Assurance Manager
Our client strives to be the testing leader in the pharmaceutical and medical device industries. Each employee must approach their job as an ongoing commitment to quality testing and customer service in order for the company to succeed. This means fulfilling commitments in both of the following key result areas:
- Our Clients. We want to help our clients deliver safe and successful health care products to the public. We do this by providing responsive, cost-effective testing services that combine outstanding technical quality, top-notch regulatory compliance, and outstanding attention to the specialized needs of our clients. All staff are expected to make client service their top priority. This means that each employee is expected to do whatever is practical to meet our clients’ needs, even if this exceeds the specific responsibilities listed in their job description.
- Our People. We consider our people to be our greatest asset, and we provide employees with a work environment that fosters teamwork, growth, flexibility, and innovation. Our strong commitment to teamwork ultimately translates into long-term trust and reliability for our clients.
SERVICE RESPONSIBILITIES TO CLIENTS
- Act as liaison to client auditors and regulatory inspectors. Host and coordinate inspections involving the company officer and department heads as necessary with regulatory agents on-site.
- Prepare responses to audit reports from clients and regulatory agencies.
- Administer system(s) for handling client problems or complaints.
- Act as a regulatory resource for clients. Ensure that all client requests for information pertaining to current regulations are met promptly and effectively.
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
- Provide laboratory staff and management with current regulations and industry compliance news by attending industry meetings and workshops and by acquiring and evaluating current guidelines.
- Together with other department managers, plan for cross-departmental workshop training as needed. Plan and hold group and one-on-one continued training on issues pertaining to regulatory compliance.
- Involve staff in audit follow-up procedures for the purpose of instruction, feedback, and continuing staff development.
- Act as a regulatory resource, support, and coordinator.
Provide leadership for Quality Improvement Projects in the following areas:
- Compliance-driven projects. Quality improvements to increase the laboratories’ level of compliance (e.g. process validation, documentation systems).
- Competitive advantage projects. Quality improvements to increase laboratory efficiency or decrease quality costs thereby providing the company with a competitive advantage.
- Measurement and feedback projects. Projects designed to measure specific quality parameters and provide organized, evaluated information to corporate officers and department heads. These include programs that measure report error rates, turnaround time, customer satisfaction, etc.
- Approve and issue Certificate of Analysis
- Structure and organize the Quality Assurance department staff, ensuring that quality functions are being performed as required.
- Conduct annual performance evaluations of departmental staff.
- Play a lead role in the company’s future planning efforts.
Core GLP Responsibilities:
- Oversee Master Schedule of GLP studies.
- Perform in-life audits of GLP studies.
- Perform final audits of GLP reports.
- Oversee archives of all GLP studies.
Core GMP/ISO Responsibilities:
- Coordinate and conduct regular Management Review Meetings.
- Perform internal audits of departments, data, systems, and facilities. Report findings to management. Organize and plan follow-up inspections as part of corrective action processes.
- Perform audits of vendors and subcontractors as mandated by executive management.
- Oversee the maintenance of Operations Manual. Maintain file of all historical procedures and protocols.
- Review new or revised SOPs generated at the facility.
- Write SOPs pertaining directly to quality functions.
- Oversee Form Control System.
- Maintain employee signatures and initials on file.
- Oversee archiving of non-GLP documentation per internal retention requirements.
- Provide new employees with appropriate training documents.
- Provide all employees with training in GMP, GLP, ISO, and other applicable regulations as well as the role of quality assurance in the laboratory.
- Maintain the company’s FDA registration and compliance to FDA regulations.
- B.S. (or equivalent in training and/or experience) required.
- Thorough knowledge and understanding of GMP/GLP regulations required.
- Thorough knowledge and understanding of ISO standards required.
- Minimum five years experience in a GMP/GLP laboratory setting required.
- Lead auditor certification preferred