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Director, Quality Assurance-Bioanalytical Labs/Clinical Trials

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Primary Location: Durham, North Carolina, United States Full time R1322480

Job description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

PURPOSE

The Director, Quality Assurance (QA) has responsibility for management and oversight of the compliance program for Good Laboratory Practices (GLP) for nonclinical development, and for GxP as it relates to bioanalytical laboratory components of clinical studies, to assure management that the bioanalytical laboratory facilities, equipment, personnel, methods, practices, records and controls for each nonclinical laboratory study are in compliance with current GLP regulations as well as consistent with client expectations and requirements to positively impact company performance. This position is responsible for management of the successful and timely execution of the internal audit program, planning and implementation of quality improvement projects, departmental budget, regulatory compliance training, and quality assurance unit (QAU) staff training and line management.

RESPONSIBILITIES

  • Provides clear direction and vision to the QAU and laboratory teams that ensures the quality programs of the Bioanalytical and ADME Laboratories are consistent with client and regulatory requirements and expectations.
  • Supports all human resources policies, such as performance development, recruiting and interviewing standards.
  • Develops direct reports and sets manageable objectives and goals for career development that also support company objectives.
  • Develops, evaluates and supports process and procedural improvements that are consistent with client and regulatory agency expectations to improve the quality, efficiency, and effectiveness of company operations.
  • Provide the required quality assurance support for data submission to regulatory bodies (e.g. GLP Study Report).
  • Monitors the QAU staff performance, sets project priorities and ensures deadlines are met to support client projects through effective teamwork, organization, and management.
  • Maintains organizational awareness of regulatory developments and requirements and has responsibility for ensuring all potential GxP compliance issues are identified and brought to the attention of appropriate business managers in a timely manner.
  • Stays current with industry trends and developments through active involvement with external professional groups.
  • Leads audits and/or inspections of all laboratory facility, process, and study data generated from such to ensure regulatory compliance.
  • Responsible for ensuring appropriate coordination of inspections by external visitors and regulatory agencies.
  • Reviews all SOPs to ensure compliance to regulatory requirements and established company procedures.
  • Assure QA oversight of computer system validation projects to meet regulatory requirements.
  • Establishes budgets for area of responsibility and works within established budgets.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of word-processing, spreadsheet, and database applications.
  • Extensive knowledge of current Good Laboratory Practices (GLP) and pharmaceutical research and development processes in regulated environments.
  • Considerable knowledge of quality assurance principles, processes and procedures.
  • Strong interpersonal skills.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation skills
  • Senior Management experience in Quality Assurance / Regulatory Compliance.
  • Ability to influence and guide others at all levels of management.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Ability to manage costs effectively through appropriate resource allocation.
  • Ability to articulate and define departmental needs and processes.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in life sciences
  • Minimum of 10 years Quality Assurance experience.
  • Experience in bioanalytical laboratories (research, sample testing, biomarkers, etc.) which support clinical trials is required. GLP knowledge and experience is required.
  • Minimum of 4 years of management experience; or equivalent combination of education, training and experience

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

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“I know Q2 Solutions offers me a great career path with lots of options. My line manager fully supports my growth.”

Marianne H, Associate Laboratory Project Set-Up Manager

“There are tremendous opportunities to grow here. If you are driven, passionate and committed, the sky’s the limit.”

P. Surve, Clinical Process Team Lead

“What gets me most excited about being part of Q2 Solutions is working with cutting-edge technologies that help patients and further innovation in the field.”

Todd L., Scientist

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