CPC

Associate Director – Quality Programs and Governance

CPC

full-time

Posted on:

Location Type: Remote

Location: Remote • Colorado • 🇺🇸 United States

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Salary

💰 $155,000 - $205,000 per year

Job Level

Senior

Tech Stack

CloudGoogle Cloud Platform

About the role

  • Manage the Quality team to ensure delivery of departmental and organizational quality objectives.
  • Define and implement the CPC Quality program and ensure that it is robust and adheres to all internal and external requirements as governed by the CPC scope of activities.
  • This program should be proactive in evolving, innovating, and anticipating organizational risks and quality gaps.
  • Define and oversee implementation of quality policies, procedures, and metrics.
  • Provide the Executive Director and Leadership Committee with key updates on a regular basis.
  • Ensure quality processes, tasks, and deliverables are on track and on schedule.
  • Identify strategic gaps, risks or deficiencies and work with the Executive Director to address them.
  • Champion CPC’s Quality Management System (QMS) and regulatory technologies.
  • Oversee the review, revision, approval, version control, and historical archival of controlled documents within the QMS.
  • Ensure compliance with regulatory requirements (e.g., FDA, HIPAA, GCP) and internal quality standards.
  • Identify potential areas of non-compliance or inefficiency and develop proactive measures to address them.
  • Lead internal auditing functions to ensure that CPC is compliant with all applicable local, federal and international regulations, guidelines and standards.
  • Oversee external audits of CPC and responses to audit observations or requests, in conjunction with appropriate Leadership Committee members.
  • Represent CPC in interactions with the FDA and other regulatory bodies.
  • Maintain and manage all GxP Clinical Systems documentation from implementation, change management, user access and audit trail review, and retirement to ensure data integrity, security and regulatory compliance.
  • Conduct external audits and risk assessments for all technology systems (on-prem, software as a service (SAAS), cloud-based, etc.), if applicable.
  • Oversee and support the build and validation of electronic data capture (EDC) clinical trial databases.
  • Lead the organizational development and maintenance of quality assurance policies, SOPs, and process documentation.
  • Identify process gaps and revise policies (POLs), standard operating procedures (SOPs) and work instructions (WIs) to ensure compliance with applicable regulations and regulatory guidance.
  • Prepare and present quality performance reports to senior leadership.
  • Lead initiatives for continuous improvement in the Quality Department.
  • Report on all significant or concerning regulatory and/or quality issues to the Executive Director.
  • Serve as an internal subject matter expert to address and resolve regulatory or quality assurance issues.
  • Supervise and lead quality team members to set clear job expectations, assess training needs and ensure team members receive training as needed.
  • Assist all personnel reporting to this position to create improvement and innovation goals annually.
  • Maintain a Society of Quality Assurance membership and participate in IT System workshops.
  • Maintain certification in CITI training as appropriate for role.

Requirements

  • Bachelor’s degree is preferred, but equivalent experience will be considered.
  • Minimum of 5 years of supervisory experience required.
  • Minimum of 7 years of IT project management; proven experience managing software implementations and database validation, preferably in healthcare or clinical research.
  • Minimum of 10 years of experience in a clinical research setting required including quality oversight responsibilities.
  • Strong knowledge of regulatory system compliance, qualification and validation.
  • Experience with technical regulatory standards like CDISC, 21CRFPart11, SOC and ISO quality frameworks.
  • Knowledge of applicable regulatory requirements (e.g. ICH, GCP, HIPPA, GDPR and FDA) for conducting clinical trials.
  • Proficient technical understanding of cloud-based IT Systems.
  • Proficiency with Microsoft Office.
  • Excellent interpersonal, oral and written communication skills.
  • Strong planning, prioritization, analytical, problem-solving, organizational skills and attention to detail.
  • Ability to work independently and as a member of a team.
  • Ability to manage conflicts and resolve problems effectively.
  • Ability and willingness to travel up to 15%.
Benefits
  • Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
  • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
  • 11 paid holidays
  • 15 - 25 vacation days based on years of service
  • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
  • In-suite exercise and relaxation room
  • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
  • Flexible and remote work schedules

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
quality management systemregulatory compliancedatabase validationsoftware implementationclinical trial databasesinternal auditingrisk assessmentquality assurance policiesprocess documentationcontinuous improvement
Soft skills
interpersonal skillsoral communicationwritten communicationplanningprioritizationanalytical skillsproblem-solvingorganizational skillsattention to detailconflict resolution
Certifications
CITI trainingSociety of Quality Assurance membership