Sr. Clinical Quality Assurance Manager

Sr. Clinical Quality Assurance Manager

Requirements

• BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred.
• Master’s degree in life sciences or related discipline and 6+ years of similar experience noted above.
• Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired.
• Experience with gene therapy clinical trials is preferred.
• Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies.
• Ability to identify and escalate problems and follow-through with the corrective actions.
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors.
• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals.
• Must possess excellent verbal and written communication skills along with sound organization skills applicable to audit planning, reporting and archiving.
• Anticipates business and industry issues; recommends relevant process improvements.
• Demonstrates broad expertise or unique knowledge.
• Considered an expert within the company and may have external presence in area of expertise.
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team.
• Ability to work as part of and lead multiple teams.
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.
• Excellent computer skills.
• Excellent communications, problem-solving, analytical thinking skills.
• Sees broader picture and longer-term impact on division/company.
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Excellent project management, strong project leadership skills.

Responsibilities

• Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles.
• Develop risk mitigation plans and strategies.
• Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary.
• Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance.
• Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management.
• Provide GCP training as needed, including Investigator Meeting training.
• Lead, plan, conduct, and oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans, and applicable policies/procedures.
• Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable.
• Assist in the audit site selection process for study-specific audit plans.
• Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs.
• Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker.
• Provide proactive audit status and metrics reports to management.
• Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training.
• Proactively research, test and implement quality systems, processes and procedures within CQA area.
• Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting.
• Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned.
• Support all on-site regulatory inspection activities.
• May work on other projects within QA not related to GCP.

Preferred Qualifications

• Experience with gene therapy clinical trials is preferred.