Sr. Director Quality Assurance - GCP/GLP

This is a remote position.

KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world’s leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements in the United States, Europe and Latin America. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!

The Role:

The Sr. Director of Quality Assurance will work with internal clinical and nonclinical functions and external parties including consultants, contract auditors, CROs and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for all programs.   Will independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners and internal systems in compliance with GCP, GLP, and Company policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.  They will support a culture of sustainable compliance; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready.

Essential Duties and Responsibilities

• Provide expertise in GCP and GLP compliance interpretation, consultation, training, and recommendations to clinical and nonclinical development functions and program teams.
  
• Assume complex assignments on issues or studies where there is no precedent.
  
• Develop and implement risk based GCP and GLP audit and compliance strategy. Audits require advanced auditing skills and involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
  
• Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
  
• In collaboration with the head of QA, facilitate GCP and GLP regulatory inspections; provide GCP and GLP compliance technical support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions.
  
• Analyze, report, and present metrics to functional teams and Quality management; recommend any required actions and monitor implementation.
  
• Identify and mitigate GCP and GLP activities and process improvement initiatives as requested by management.
  

Requirements

• BA/BS degree required; advanced degree
  
• Minimum of 15 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be hands-on GCP and GLP Quality Assurance experience
  
• Operational Experience (e.g., Clinical Operations, Data Management, etc.) an advantage
  
• Self-motivated leader with extensive knowledge and/or awareness of ICH GCP, GLP regulations (21 CFR Part 58 and OECD Principles) and applicable global regulations and guidance for clinical and nonclinical development.
  
• Advanced knowledge in the conduct and reporting of audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and the clinical programs.
  
• Experience preparing for and participating in GCP and GLP regulatory inspections.
  
• Strong technical writing skills; ability to write clear quality position statements, risk-based audit reports, and procedures.
  
• Excellent communication skills.
  
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
  
• Ability to rapidly synthesize complex issues and identify risks in a pragmatic way
  
• Extensive experience in building GCP and GLP systems and processes.
  
• This position can be hybrid based in San Diego, CA or Remote.
  

Benefits

Our client offers a comprehensive benefits package including:

401k Matching

Family and Individual Insurance Packages (Health, Life, Dental, and Vision)

Paid Time Off & Paid Holidays

Long & Short-Term Disability

Identity Theft Plans

Retirement & Pension Plans

Employee Assistance Program

Employee Referral Program

Tuition Reimbursement Programs

Advancement & Professional Growth opportunities 

Parental Leave

& More