As a member of ONO Group
Senior Manager, Clinical Quality Assurance
Location
Massachusetts
Posted
30 days ago
Salary
$138K - $190K / year
Seniority
Senior
Job Description
Senior Manager, Clinical Quality Assurance
Deciphera Pharmaceuticals
• 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.
Job 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.
- Willingness to travel up to 25% both domestic and international.
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.
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