Description
\t\t\t\t\tQuality 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,, 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:•\tLeads 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. •\tSupports the implementation and management of the Pharmacovigilance (PV) Quality Management System (QMS) and PV System for clinical and commercial operations, partnering with Patient Safety. •\tContributes to QA audit planning and performs GCP, GLP, and PV audits of sites, systems, vendors, and documents. •\tManages external auditors, including contracts and audit-specific activities. •\tSupports the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems. •\tEnsures ongoing qualification of GCP, GLP, and Good Pharmacovigilance Practice (GVP) vendors and systems.•\tPrepares and negotiates Quality Agreements with vendors. •\tManages study, GCP, GLP, and GVP deviations, quality issues, Corrective and Preventive Actions (CAPA), effectiveness checks, and root cause analysis.•\tDirects Serious Breach processes and reporting.•\tPartners with GxP functions to ensure alignment within the QMS and regulatory compliance. •\tParticipates in and leads Inspection Readiness efforts and inspections (GCP, GLP, and GVP/Pharmacovigilance.•\tAdvises stakeholders on GCP, GLP, and GVP compliance issues.•\tPrepares Key Performance Indicators (KPIs) for performance monitoring and Management Oversight.•\tContributes to the development and approval of QA, GCP, GLP, and GVP procedures (Standard Operating Procedures (SOPs)).•\tAssists in providing GxP training to staff. •\tSupports departmental GxP activities and projects.
\t\t\t\t\tSkills
\t\t\t\t\tQuality assurance, investigations, Quality management, Compliance, GCP, pharmacovigilance, Cell Therapy, GLP, ICH, QMS, Audit, CAPA, root cause analysis, GXP, Project management, Pharmaceutical, Inspection
\t\t\t\t\tTop Skills Details
\t\t\t\t\tQuality assurance,investigations,Quality management,Compliance,GCP,pharmacovigilance,Cell Therapy,GLP,ICH,QMS,Audit,CAPA,root cause analysis
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tQualifications:•\tBS with 8+ years or MS/PhD degrees 6+ years of leadership experience in biopharmaceutical quality assurance and clinical quality assurance. •\tIn-depth knowledge of Good Clinical Practices (GCP), and other applicable regulations and standards.•\tExperience conducting and hosting internal and external audits and inspections.•\tExperience developing, implementing, and maintaining quality systems and procedures.•\tExcellent leadership, communication, interpersonal, and problem-solving skills.•\tAbility to work independently and as part of a cross-functional team.•\tExperience in cell therapy quality preferred.•\tExperience in late stage clinical/commercial.•\tExperience leading health authority inspections required. GCP Sponsor inspection, PAD, Safety inspection requiredMust be able to consult and advise GCP group, not just audit.
\t\t\t\t\tExperience Level
\t\t\t\t\tExpert 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 22, 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.
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