Maryland Staffing
Quality Assurance Associate Director
Maryland Staffing, Frederick, Maryland, United States, 21701
Quality Assurance Director
Quality Assurance Director with extensive experience in biopharmaceutical quality assurance and management of quality programs for clinical cell therapy assets. The ideal candidate will be a highly motivated professional who can oversee Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP, GLP, and PV operations in a fast-paced cell therapy environment. The candidate should embrace a collaborative work environment and be able to execute multiple projects concurrently. This position is ideal for candidates with experience in GCP environments, with knowledge of ICH guidelines and FDA compliance for investigational late stage/commercial cell therapy products. Principal Duties/Responsibilities: Leads Quality Assurance (QA) oversight for assigned studies, ensuring compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) in collaboration with Clinical Operations and CRO teams. Supports the implementation and management of the Pharmacovigilance (PV) Quality Management System (QMS) and PV System for clinical and commercial operations, partnering with Patient Safety. Contributes to QA audit planning and performs GCP, GLP, and PV audits of sites, systems, vendors, and documents. Manages external auditors, including contracts and audit-specific activities. Supports the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems. Ensures ongoing qualification of GCP, GLP, and Good Pharmacovigilance Practice (GVP) vendors and systems. Prepares and negotiates Quality Agreements with vendors. Manages study, GCP, GLP, and GVP deviations, quality issues, Corrective and Preventive Actions (CAPA), effectiveness checks, and root cause analysis. Directs Serious Breach processes and reporting. Partners with GxP functions to ensure alignment within the QMS and regulatory compliance. Participates in and leads Inspection Readiness efforts and inspections (GCP, GLP, and GVP/Pharmacovigilance). Advises stakeholders on GCP, GLP, and GVP compliance issues. Prepares Key Performance Indicators (KPIs) for performance monitoring and Management Oversight. Contributes to the development and approval of QA, GCP, GLP, and GVP procedures (Standard Operating Procedures (SOPs)). Assists in providing GxP training to staff. Supports departmental GxP activities and projects. Skills Quality assurance, investigations, Quality management, Compliance, GCP, pharmacovigilance, Cell Therapy, GLP, ICH, QMS, Audit, CAPA, root cause analysis, GXP, Project management, Pharmaceutical, Inspection Top Skills Details Quality assurance, investigations, Quality management, Compliance, GCP, pharmacovigilance, Cell Therapy, GLP, ICH, QMS, Audit, CAPA, root cause analysis Additional Skills & Qualifications: BS with 8+ years or MS/PhD degrees 6+ years of leadership experience in biopharmaceutical quality assurance and clinical quality assurance. In-depth knowledge of Good Clinical Practices (GCP), and other applicable regulations and standards. Experience conducting and hosting internal and external audits and inspections. Experience developing, implementing, and maintaining quality systems and procedures. Excellent leadership, communication, interpersonal, and problem-solving skills. Ability to work independently and as part of a cross-functional team. Experience in cell therapy quality preferred. Experience in late stage clinical/commercial. Experience leading health authority inspections required. GCP Sponsor inspection, PAD, Safety inspection required Must be able to consult and advise GCP group, not just audit. Experience Level Expert Level Pay and Benefits The pay range for this position is $75.00 - $92.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Frederick, MD. Application Deadline This position is anticipated to close on Sep 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Quality Assurance Director with extensive experience in biopharmaceutical quality assurance and management of quality programs for clinical cell therapy assets. The ideal candidate will be a highly motivated professional who can oversee Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP, GLP, and PV operations in a fast-paced cell therapy environment. The candidate should embrace a collaborative work environment and be able to execute multiple projects concurrently. This position is ideal for candidates with experience in GCP environments, with knowledge of ICH guidelines and FDA compliance for investigational late stage/commercial cell therapy products. Principal Duties/Responsibilities: Leads Quality Assurance (QA) oversight for assigned studies, ensuring compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) in collaboration with Clinical Operations and CRO teams. Supports the implementation and management of the Pharmacovigilance (PV) Quality Management System (QMS) and PV System for clinical and commercial operations, partnering with Patient Safety. Contributes to QA audit planning and performs GCP, GLP, and PV audits of sites, systems, vendors, and documents. Manages external auditors, including contracts and audit-specific activities. Supports the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems. Ensures ongoing qualification of GCP, GLP, and Good Pharmacovigilance Practice (GVP) vendors and systems. Prepares and negotiates Quality Agreements with vendors. Manages study, GCP, GLP, and GVP deviations, quality issues, Corrective and Preventive Actions (CAPA), effectiveness checks, and root cause analysis. Directs Serious Breach processes and reporting. Partners with GxP functions to ensure alignment within the QMS and regulatory compliance. Participates in and leads Inspection Readiness efforts and inspections (GCP, GLP, and GVP/Pharmacovigilance). Advises stakeholders on GCP, GLP, and GVP compliance issues. Prepares Key Performance Indicators (KPIs) for performance monitoring and Management Oversight. Contributes to the development and approval of QA, GCP, GLP, and GVP procedures (Standard Operating Procedures (SOPs)). Assists in providing GxP training to staff. Supports departmental GxP activities and projects. Skills Quality assurance, investigations, Quality management, Compliance, GCP, pharmacovigilance, Cell Therapy, GLP, ICH, QMS, Audit, CAPA, root cause analysis, GXP, Project management, Pharmaceutical, Inspection Top Skills Details Quality assurance, investigations, Quality management, Compliance, GCP, pharmacovigilance, Cell Therapy, GLP, ICH, QMS, Audit, CAPA, root cause analysis Additional Skills & Qualifications: BS with 8+ years or MS/PhD degrees 6+ years of leadership experience in biopharmaceutical quality assurance and clinical quality assurance. In-depth knowledge of Good Clinical Practices (GCP), and other applicable regulations and standards. Experience conducting and hosting internal and external audits and inspections. Experience developing, implementing, and maintaining quality systems and procedures. Excellent leadership, communication, interpersonal, and problem-solving skills. Ability to work independently and as part of a cross-functional team. Experience in cell therapy quality preferred. Experience in late stage clinical/commercial. Experience leading health authority inspections required. GCP Sponsor inspection, PAD, Safety inspection required Must be able to consult and advise GCP group, not just audit. Experience Level Expert Level Pay and Benefits The pay range for this position is $75.00 - $92.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Frederick, MD. Application Deadline This position is anticipated to close on Sep 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.