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 bolthires 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 Apply tot his job

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