This position is responsible for oversight of the auditing department, ensuring the company and its vendors are compliant with company, industry and regulatory guidelines and requirements. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
Develops and maintains Internal Audit and Supplier Audit programs.
Conducts audits of donor centers, corporate office, laboratories, distribution centers, storage warehouse and suppliers to ensure compliance with FDA, EU, IQPP, and cGMP regulations.
Conducts “For Cause” audits.
Prepares audit schedule and audit schedule changes.
Develops center, corporate, supplier, and third party compliance checklists, in
collaboration with the Director of Compliance.
Audits donor records files, processing records and manufacturing records to determine compliance with company SOPs and policies.
Prepares audit reports based on audit findings.
Reviews audit findings with auditors prior to assignment of observation severity.
Evaluates audit responses for adequacy, including root cause analysis.
Conducts follow-up actions for center, corporate and supplier audits as required to ensure CAPA implementation and compliance.
Tracks and trends internal audit findings.
Coordinates the identification of systemic audit findings for process improvement initiatives and adherence to SOP.
Manages department employees including training, performance evaluations, career development, compensation administration and progressive discipline as needed according to company policies.
Trains auditors regarding the audit process, findings, reports, and follow-up actions.
Conducts regularly scheduled staff meetings with Auditors, Sr. Corporate Compliance Auditor, and Sr. Vice President, Regulatory Affairs & Quality Assurance.
Serves as a contributing member of the weekly Quality Department meetings.
Other job-related responsibilities as required.
Bachelor’s degree in life science or related field.
Minimum five years’ experience in biologics, biotechnology or pharmaceutical industry with increasing regulatory compliance responsibilities or equivalent combination of education and experience.
One year management experience.
Knowledge of FDA and EU regulations and standards.Strong written and verbal communication skills.
Plasma industry experience preferred.Advanced auditor certification preferred, such as ASQ Certified Quality Auditor (CQA).
Physical and Mental Working Conditions
Frequently required to travel overnight.
Frequently performs work while sitting.
Required to communicate and interact with employees and vendors.
For over 25 years, BPL has been a leader in the plasma industry. We are recognized both in the United States and in other countries for the consistently high quality of product we provide to pharmaceutical companies around the globe. BPL Plasma, Inc. is a subsidiary of Bio Products Laboratory Ltd, who manufactures a wide range of plasma products. Located in Elstree, near London (UK), we are commi...tted to research and development to maintain a key position in a constantly changing market in the 21st century.
BPL has 34 plasma centers throughout the United States. All of our plasma centers are FDA regulated and follow all industry guidelines. We pride ourselves on operating modern plasma facilities staffed with trained and friendly personnel.
In addition to collecting life-saving plasma, BPL compensates donors for their time, resulting in the infusion of thousands of dollars in to the local communities surrounding the centers. Moreover, BPL centers are involved in local area Chambers of Commerce and sponsor community activities such as neighborhood cleanups.