The Director, Audits and Compliance, is responsible and accountable for compliance and oversight of LabConnect’s audit program, vendor management and internal processes in QMS. Ensures audit readiness, risk-based audit management and a strategic plan for quality compliance towards excellent customer satisfaction. This role builds and leads a highly performing global team to ensure quality risk management across all areas and a quality plan that covers internal, external, client and regulatory audits and their effectiveness. This position will have Quality leadership responsibilities for critical escalations, critical vendor management, regulatory and quality compliance and SME contribution to key strategic initiatives, contract management, gap analyses, validation, and project management. Serves as internal regulatory SME when required.This position is ideally suited for candidates within commuting distance to Johnson City, TN, Cleveland, OH, or in the Eastern US time zone.Essential Duties and Responsibilities
Define, develop, implement, and oversee an effective risk-based audit program at LabConnect, driving customer satisfaction and regulatory compliance.
QA Leadership and management of strategic corporate initiatives from a quality and compliance perspective, working collaboratively across all functions including internal and external partners
Lead critical client communications, contractual engagement, and issues management as needed. Build effective internal relationships to support client needs and quality standards.
Review, Edit, and implement standardized contracts, support LC sites for maintaining all regulatory standards, accreditation (including partner labs), and certifications. Proactively support roadmap and implementation of newer industry standards,
Advise on compliance and best practice knowledge for all LC teams, including providing training to standards in collaboration with HR.
Maintain and expand regulatory knowledge, to the ICH Principles of GCP, General Data Privacy Regulation and International GCPs, GLPs, Computer systems regs and other applicable areas
Lead and serve as primary, for Sponsor Audits, Software Assessments, Critical Vendor Audits, Gap Analyses, Trial Specific Audits and other key critical auditing, risk mitigation, and regulatory assessment activities.
Assisting management in assuring organizational readiness for audits and inspections by scheduling, coordinating, conducting, and documenting gap analyses.
Utilizing risk-based decision making and critical thinking in evaluating potential audit candidates, facilities, documents, and key quality systems. Partner closely with client facing functions to proactively build quality factors in selection of vendors and service providers, and their management.
Own, define and maintain all internal processes and SOPs governing Audits and Compliance activities at LC.
Clear and concise communication of audit outcomes and management reporting for regulatory and quality metrics across the QMS and business performance
Supervise and assist in management of Non-Conformance reporting and their related preventive measures and due diligence and other areas in Quality as tasked.
Performs other related duties and tasks as necessary or as assigned.
Education and Qualifications:
Bachelor's degree in relevant scientific discipline (e.g., Biology, Chemistry, Medical Technology, Engineering).
Advanced degree (e.g., Master's, PhD) in a relevant scientific discipline, preferred.
Minimum of 10 years of experience in quality and operations within the central laboratory, biotech, or pharma industry with expertise in GxPs and managing regulatory compliance including interaction with Health Authorities. Must have minimally 6 years of auditing and inspections experience.
Strong knowledge of regulatory requirements (e.g., CLIA, CAP, ISO 15189, GxP, CFR Part 11, Annex 11, ISO9001, ICH guidelines) and industry standards.
Proven experience in leading and managing quality teams in a global, multi-site environment.
Very strong communication and collaboration skills, with timely decision making and risk management.
Required Skills:
Excellent problem-solving skills and the ability to drive continuous improvement initiatives.
Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Proficiency in operational management systems such as Veeva, LIMS and other applications supporting GxP.
Effective decision making and application of sound judgement in issue escalation to management with proposals and sense of urgency.
Experience in defining and providing metric based assessments of QMS to drive the right decisions.
Language AbilityAbility to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.Math AbilityAbility to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Reasoning AbilityAbility to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Computer SkillsTo perform this job successfully, an individual should have knowledge of Microsoft Office applications, word processing software, spreadsheet software and database software.Physical Demands:While performing the duties of this job, the occupant is regularly required to:
Prolonged periods of sitting at a desk and working on a computer.
Prolonged use of computer and headphones for conference calls.
Communicate effectively via phone, video, and email.
Use hands and fingers to operate a computer and other office equipment.
