Manager Clinical QA

Job Title: Manager Clinical QA

Job Number: 33196

Location: Remote, 

Job Description

The Clinical Quality Assurance Manager will be responsible for overseeing all necessary audits related to clinical studies, as well as internal and external audits of GCP systems and processes. They will also manage and support quality-related activities and systems related to clinical studies, as well as any GCP or GPVP inspections/audits by Regulatory Authorities. The manager will collaborate with other departments to develop and manage timelines for GCP audits of vendors and clinical sites, with the goal of ensuring GCP compliance. Additionally, they will establish metrics for Quality Assurance to evaluate compliance with GCP and identify potential compliance risks, as well as enhancing proactive risk-based auditing.

Responsibilities

Ensure readiness for inspections by creating a compliance audit plan that includes internal and external audits. Help with inspection preparation and provide support during inspections. Coordinate and supervise audits, such as sponsor GCP audits of investigational sites and internal audits, to ensure compliance with regulatory requirements, guidelines, study protocols, monitoring plans, and policies/procedures, and GPVP audits of the safety department. Conduct audits, either alone or with other auditors, as required to meet the audit program's needs, and create SOPs, audit report templates, work instructions, or job aids. Track audit findings and identify potential quality risks, escalate them to management, and provide GCP/QA expertise to clinical staff. Ensure that adequate resources are available to meet the audit plan's requirements and manage contract auditors. Review deviations, participate in quality improvement efforts, and review controlled documents and process assessments to identify potential quality and compliance gaps. Conduct and/or support meetings, provide department support activities, and coordinate/facilitate lessons learned initiatives for the department and cross-functional teams as needed.

Required Skills

To qualify for this position, candidates should hold a Bachelor's degree in a science or health-related field, or an equivalent combination of education and experience. Having an advanced degree is preferred. Candidates must have at least 7 years of project management experience in the life-science industry or demonstrate the necessary skills for this position, and a minimum of 3 years of direct clinical (GCP/GPVP) Quality Assurance experience. Candidates must have direct work experience in a global, cross-functional project management role in the life sciences, and knowledge of FDA and/or EMA regulations, ICH guidelines, and GxP governing pharmaceutical development activities. Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and SharePoint, is required, as well as experience with project management software like MS Project or SmartSheet. Candidates should possess excellent interpersonal skills and leadership abilities, as well as excellent verbal, written, and presentation skills. They should be able to distill and communicate key information to relevant audiences and possess root cause analysis, problem-solving, and analytical skills. Candidates must demonstrate the ability to organize multiple priorities and projects, focus on results, work collaboratively across functions, and proactively ensure continual learning by staying up-to-date with the latest Agency guidance and industry best practices.

Compensation and Benefits:
Salary range: $115,000-130,000/year

Benefits:
Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
401(k)
Paid Time Off (PTO)