Associate Director – Quality Programs and Governance

Job Description:

• 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

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