Vice President, Quality
General Summary
The Vice President (VP) Quality at Southern Research will be an integral member of the executive leadership team, responsible for shaping the overall quality strategy and ensuring that all operations meet the highest standards of regulatory, scientific, and operational excellence. In this role, the VP Quality will provide executive-level leadership to the Quality team and will also be responsible for establishing and maintaining a robust Quality Management System (QMS). In addition, the VP Quality will foster a culture of continuous improvement and process discipline, mentor and develop the Quality team, and serve as a key advocate for upholding Southern Research's commitment to regulatory excellence and operational integrity in a dynamic and challenging preclinical CRO environment.
Essential Duties & Responsibilities
- Quality Strategy & Leadership
- Develop and Execute Strategy: Formulate a long-term quality vision and objectives, aligning them with corporate and operational goals. Ensure that the Quality framework underpins all initiatives, fostering coherence between QA, QS, QIT, and Archives.
- Lead the Quality Function: Provide leadership and direction to the Quality team (including QA, QS, QIT, and Archives), driving robust processes for document management, training management, deviation handling, and change control.
- Foster a Culture of Excellence: Promote adherence to industry best practices and quality standards, integrating quality focused continuous improvement principles into all activities across the organization.
- Budget Oversight: Manage the Quality organization's budget, ensuring effective resource allocation for QA, QIT, Archives, and QS functionalities.
- Quality Assurance (QA)
- Quality Management System (QMS): Oversee the implementation, maintenance, and optimization of a comprehensive QMS, ensuring processes are efficient, scalable, and compliant with applicable guidelines. Leverage QS tools (e.g., eQMS) to streamline document control, training, deviation management, audit, CAPA, CI, Validation, etc.
- Operational Excellence: Collaborate with cross-functional teams-such as Research & Development, Operations, and Business Development-to integrate quality considerations into project lifecycles, aligning with both regulatory and organizational objectives.
- Internal Audits & CAPA: Oversee internal audits, manage corrective and preventive actions (CAPAs), and track issues to resolution. Ensure findings inform ongoing improvement of QS processes.
- Regulatory Compliance
- Regulatory Alignment (e.g., FDA/EPA/USDA): Ensure that the organization's operations, data integrity, and documentation are aligned with relevant regulatory requirements through robust quality processes.
- Inspection Readiness: Oversee or support inspections and audits by regulatory bodies, external partners, or clients; ensure timely follow-up and resolution of any findings.
- Subject Matter Expertise: Serve as an expert on quality and regulatory issues, guiding quality focused improvements to maintain compliance with evolving guidelines and partnering with compliance functions as needed.
- QIT Systems
- Technology Leadership: Guide the strategic direction and integration of applications, including eQMS, LIMS, and other specialized software, to ensure regulatory compliance, inspection readiness, operational integrity, accurate data capture, and workflow efficiency.
- Systems Validation: Oversee validation activities, upgrades, and ongoing maintenance of computerized systems within the QS framework, ensuring compliance with industry standards and effective change control.
- Continuous Improvement: Evaluate emerging technologies that enhance quality processes-such as deviation management, CAPA tracking, and training modules-to promote operational excellence, data integrity, and sponsor satisfaction.
- Archives & Document Management
- Archival Strategy: Develop and maintain a comprehensive archives framework for study reports, scientific data, records, specimens, and critical documentation.
- Document Control: Implement robust, QS-driven processes for versioning, secure storage, and retrieval to support research, client needs, and potential audits.
- Long-Term Integrity: Ensure adherence to best practices in data retention and integrity, aligning with industry standards for sustained organizational and regulatory compliance.
- Risk Management & Continuous Improvement
- Risk Assessment: Proactively identify quality-related risks, leveraging the eQMS framework to manage a risk register and implement mitigation strategies.
- Quality Metrics & KPIs: Establish key performance indicators (KPIs) within the eQMS to measure progress, track quality performance, and inform leadership of trends or potential issues.
- Continuous Improvement Initiatives: Champion initiatives that elevate operational efficiency, reduce errors, and enhance customer and sponsor satisfaction, using QS tools (e.g., deviation management, CAPA) to track and measure effectiveness.
- Cross-Functional Collaboration
- Teamwork & Communication: Collaborate with operational and business units to ensure that quality processes and requirements are embedded at every project stage.
- External Partnerships: Manage relationships with external stakeholders (e.g., sponsors, industry partners, auditors), serving as a primary contact for all qualityrelated matters.
- Executive Reporting: Present regular updates on quality metrics, risk management, and improvement strategies-including those facilitated by eQMS-to the executive leadership team.
- Team Development & Mentorship
- Leadership & Coaching: Build and lead a high-performing quality team, providing mentorship, training, and professional development opportunities in best quality practices.
- Performance Management: Set clear expectations, monitor performance, and create a supportive environment that encourages growth, excellence, and ongoing engagement with quality initiatives.
- Knowledge Sharing: Encourage ongoing education on industry trends, regulatory changes, and best practices. Leverage eQMS platforms to disseminate knowledge, standardize procedures, and align the team's efforts with organizational quality goals.
Requirements/Minimum Qualifications
- Bachelor's degree in Life Sciences (Biology, Chemistry, or related field) required.
- 15 years of experience in quality assurance, regulatory affairs, or quality management in the life sciences or pharmaceutical industry.
- 5 years in a leadership role with demonstrated success in building and managing QA teams and systems. Experience with a preclinical CRO preferred.
- Has a thorough understanding of quality systems and compliance requirements for life sciences or contract research services field.
- Expertise in Quality Systems and compliance, proven track record of implementing QMS, conducting audits, and driving continuous improvement.
- Familiarity with FDA, EPA, USDA guidelines and inspection processes; experience with hosting regulatory inspections and responding to audit findings.
- Strong knowledge of US FDA/EPA GLPs, quality standards, and industry best practices.
- Experience hosting regulatory inspections and interacting with regulators.
- Experience with electronic system workflows (eQMS, LIMS, etc.), including system validation and data integrity.
- Demonstrated ability to analyze data, identify trends, and implement effective solutions.
- Exceptional strategic thinking and decision-making abilities.
- Excellent verbal, written, and interpersonal communication; able to influence stakeholders at all levels.
- Proven ability to lead, mentor, and develop a diverse team in a dynamic, fast-paced environment.
- Strong project management skills to balance multiple priorities and projects simultaneously.
- Certification in a professional quality organization, e.g., Registered Quality Assurance Professional in Good Laboratory Practice.
- Eligibility to work in the U.S. without visa sponsorship.
Knowledge/Skills/Abilities
- Proficient in managing enterprise SaaS platforms, preferably from a business and operations compliance perspective.
- Familiarity with regulatory frameworks (e.g., GxP, FDA 21 CFR Part 11) is strongly preferred.
- Strong understanding of IT infrastructure, security principles, data governance, and compliance.
- Proven leadership and project management experience.
- Ability to work collaboratively across departments and drive business application improvements.
- Strong analytical, problem-solving, and decision-making abilities, with the capacity to translate business needs into actionable insights.
- Excellent communication and stakeholder management skills.
Core Values
Cultivating human connection - putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.
Operating with precise execution - measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.
Harnessing relentless curiosity - our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.
Stewarding a healthy community - implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.
Job Specific Behaviors
Strategic Vision and Leadership - Establishes multi-year business division vision. Participates with other senior leaders to develop the overall organization mission, vision, and strategic plan. Committed to leadership excellence and models leadership competencies.
Strategic Decision Making - Obtains information and identifies key issues relevant to achieving a long-range goal; commits to a course of action to accomplish goal after developing alternatives based on logical assumptions, facts, constraints & resources.
Strategic Relationship Building - Uses appropriate interpersonal skills to work effectively with others to meet mutual goals and objectives; understands the role & interrelationships of each organizational function. Possess skills in managing across functional and organizational lines.
Operational & Technical Excellence - Ensures that work products enable the organization to meet or exceed our customer's expectations.
Communications - Expresses thoughts and ideas effectively in individual and group situations; adjusts language to the needs of the audience.
Goal Setting - Establishes stretch goals and manages to focused outcomes. Demands excellence. Demonstrates a strong commitment to organizational success; works to do what is best for all stakeholders.
Change Leadership - Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitates the implementation and acceptance of change within the workplace.
Team Building - Creates a climate of teamwork to achieve objectives, taking advantage of our diversity; creates a sense of ownership and encourages individuals to stretch beyond their own capabilities.
Coaching and Development - Selects for talent. Sets expectations and provides clear and timely feedback. Motivates, develops self and others to foster a learning environment and openly shares information that would guide others. Uses appropriate interpersonal style to guide direct reports to action. Selects for talent, sets expectations, provides clear feedback, motivates, develops self and others; fosters a learning environment; recognizes performance success.
Business Knowledge - Maintains external awareness of business sectors; applies knowledge of Institute's culture, business processes and tools to achieve goals.
Physical Demands
- Ability to perform work utilizing a computer for extended periods of time.
- Ability to sit for extended periods of time without being able to leave the work area.
- As related to laboratory work (as applicable):
- Ability to stand for extended periods of time without being able to leave the work area.
- Ability to climb ladders and stairs in performing the work.
- Ability to walk for reasonable distances in performing the work.
Certifications, Licenses & Registrations
- Certification in a professional quality organization, e.g., Registered Quality Assurance Professional in Good Laboratory Practice.
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Southern Research Institute
Feb 19, 2025 