Senior Manager, Clinical Quality Assurance

Deciphera Pharmaceuticals • Waltham, MA

6h • Hybrid

About The Position

The Senior Manager, Clinical Quality Assurance is responsible for the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Deciphera. The primary responsibilities are to ensure both quality and compliance of Deciphera sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, and country specific), along with current industry standards and practices.

Requirements

• 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

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
• Assist and advise with training QA and clinical staff as necessary for GCP
• Identify potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation
• As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board
• Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
• 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
• Assist with inspection readiness, and regulatory inspections as needed
• Other duties and responsibilities as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 101-250 employees