Senior Manager, Clinical Quality Assurance

Key Responsibilities

• Draft, review or revise Clinical QA SOPs to assess consistency and compliance with regulatory requirements/internal standards
• Attend cross-functional team meetings and provide guidance to clinical operations staff based on interpretation of current regulations to ensure best practices including risk-based management
• Work closely with Clinical Operations to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventative action (CAPA) plans, as necessary
• Provide Quality Control (QC) review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports and other clinical trial related documents
• Audit Planning and Oversight 40%
  • Conduct and/or assist in internal audits (systems, processes, vendors, computer system validation)
  • Interact with contract auditors in the scheduling process, kick-off meetings with auditors and internal groups, assist in the drafting of audit plans, confirmation letters and agendas, etc.
  • Identify the need for, conduct and/or assist in external audits (includes, but is not limited to, investigator sites, central IRBs, CROs and clinical labs)
  • Oversee the audit response process for the Investigator Site and Contract Research Organization (CRO) audits/inspections and ensure acceptability of actions to address findings through the CAPA process
• Inspections 10%
  • Assist with inspection readiness, and regulatory inspections as needed

Qualifications

• 8+ years of direct GCP pharmaceutical/biotechnology experience with Bachelors degree or equivalent
• Solid understanding and application of GCP, GLP and ICH requirements, especially ICH E6R3
• A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
• Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
• The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Broad experience in product development, clinical operations, regulatory compliance and GCP auditing
• Willingness to travel up to 25% both domestic and international

Additional Information

• Competitive salary and annual bonus
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more
• Generous parental leave and family planning benefits
• Outstanding culture and opportunities for personal and professional growth