The Quality and Regulatory Manager position is responsible for ensuring the Company and our suppliers follow Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practice (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards.
Responsible for monitoring compliance with all applicable regulations (local, State, Federal, International, FDA, AABB, OSHA and other applicable agencies). Monitor compliance through performing internal audits, managing deviations, review and approval of standard operational procedures (SOPs), other controlled documents and validation plans and the review and assessment of other Quality Systems reports (e.g., customer complaints, risk management reports, etc.).
Provide consultation for operations concerning IRB approvals, regulations, appropriate standard operating procedures, and validation protocols.
Prepare for, facilitate and participate in quarterly QA Management Meeting and quarterly Change Control Meetings.
Perform internal audits, manage results and report results to executive management.
Participate as a team member or serve as project lead and manage quality improvement projects.
Develop, review, and revise general QA department (QMS) SOPs.
Perform final QA batch record reviews for the release of GMP products.
Performs all other duties, at the discretion of management, as assigned.
Quality Management Activities:
Process improvement activities including developing statistical reports for tracking and trending quality system reports for reporting to executive management.
Evaluate & review operational policies and procedures to ensure that SOPs are clear, accurate, concise, and complete before approval.
Evaluate and approve employee training and competency programs to ensure compliance with all regulatory requirements.
Responsible for developing, maintaining and training on QA, Quality Systems, and Regulatory policies and procedures.
Provide initial and ongoing annual training for GMP, GTP, GCP, GLP, and GDP for all staff.
Communicate with and advise customers regarding quality assurance requirements and activities.
Work with other QA management staff to ensure an adequate internal assessment program is maintained.
Review Change Control and Document Change Control request to ensure all aspects of the proposed changes and project plan are adequate before issuing approval.
Quality system reports oversight including deviations, complaint, exceptions, MRBs, etc. Monitors compliance and generates statistics for tracking and trending purposes. Assist in the development of Corrective Actions and Preventative Actions if necessary.
Work closely with HemaCare Medical Directors to ensure that operational/clinical activities, policies and procedures meet standards to ensure donor, staff and patient safety.
Regulatory Management Activities
Interface with regulatory agencies, accreditation bodies and customers on issues related to Quality and Regulatory systems and IRB issues.
Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance. Notify operations of regulatory changes.
Review and approve operational SOPs for regulatory compliance.
Support regulatory inspections and Customer Supplier Qualification Audits, coordinate responses, maintain all applicable documentation and records.
Process and maintain all required licenses, permits, registrations and accreditations.
Supplier/Vendor Management Activities
Coordinate and Manage Supplier/Vendor Qualifications for HemaCare’s suppliers/vendors. Maintain all applicable documentation and records.
Coordinate with operations to ensure all critical supplies and services are assessed for criticality and are obtained from approved suppliers.
Ensure approved suppliers are re-qualified at appropriate intervals.
Monitor FDA warning letters to ensure currently approved suppliers are not under regulatory restrictions which might impact HemaCare’s critical supplies.
Perform onsite audits of suppliers as a component of supplier qualifications/requalification as deemed necessary.
Validation Management Activities
Responsible for ensuring the organization’s validation program and practices are compliant with all of the most current applicable regulatory requirements and are current with the industry standard. Also, be responsible for prioritizing tracking, and reporting of major validation initiatives.
Lead cross-functional project teams in the development and implementation of validation plans and protocols.
Maintain Validation Master Plans to ensure compliance with regulatory requirements and current industry practices.
Review and approve validation plans related to equipment, software, process, facility, and cleanroom related protocols.
Review and approve completed validation documentation.
Present HemaCare’s validation processes and documentation during external audits (e.g., FDA, AABB, customer and other regulatory agency inspections).
Donor Deferral and Document Control Management Activities
May have oversight of donor deferral activities including product quarantine/retrieval/recall, consignee notifications and Federal, State and County notifications and review of records: Post Donation Information, abnormal test results, potential duplicate donors.
May have oversight of document control activities including working with document control staff to maintain strict document control of SOPs, forms, validation plans and other associated documents.
Training Management Activities
May have oversight of training management activities including coordinating, scheduling, documenting, and maintaining training activities within a cGMP environment. Training consists of but is not limited to new hire training, annual refresher training, departmental and interdepartmental specific training, competency assessments and remedial training for all HemaCare employees.
Additional Salary Information: Based on experience
Internal Number: 2526
HemaCare is a global leader in the customization of human-derived biological products and services for biomedical research, drug discovery, process development, and cell and gene therapy starting material. The company’s network of FDA-registered, GMP/GTP-compliant collection centers ensure fresh donor material is available to customers and for use within HemaCare’s GMP-compliant isolation laboratory. Human biological material including peripheral blood, bone marrow, and cord blood is isolated into various primary cell types for fresh and frozen distribution.