Director, GxP Systems
General Summary
The Director, GxP Systems will lead the business and compliance aspects of implementation, validation, deployment, adoption, optimization, and overall governance of GxP applications within Operations. This individual will oversee key research-focused systems-including mission-critical platforms such as Veeva, Provantis, and Benchling-ensuring they align with Operations objectives, maintain regulatory compliance, and support broader organizational goals.
In addition, the Director will facilitate and drive critical decisions regarding system selection, upgrade purchases, and retirement, while also establishing application objectives and maintaining training documentation. A key focus of this role is enhancing functionality, improving user adoption, and managing solutions that support core business strategies.
This position will act as a liaison between internal stakeholders and end-users to ensure GxP applications align with operational needs. The Director, GxP Systems will collaborate with Information Technology (IT) resources to ensure proper integration, security, and compliance of applications while focusing on business-specific needs and regulatory adherence.
This position may be remote, with occasional travel to Birmingham, AL.
Essential Duties & Responsibilities
- Serves as the Business Owner for Operations applications, including Veeva, Provantis, and Benchling, ensuring their effective management, optimization, and alignment with business needs.
- Develops and Implements a Strategic Framework for the management and continuous improvement of GxP applications in Operations, with an initial focus on Veeva, Provantis, and Benchling.
- Engages with Stakeholders to identify business needs, define functional requirements, and collaborate with IT on system enhancements, while leading communication, change management, and user adoption efforts for new features, updates, or process changes.
- Oversees the business and compliance lifecycle of GxP Applications, from implementation and validation to deployment, adoption, optimization, and ongoing governance within Operations.
- Manages Project Planning and Execution, defining schedules, milestones, and deliverables to ensure timely, budget-compliant, and high-quality implementation of application initiatives. Ensures alignment with corporate objectives by coordinating cross-functional collaboration.
- Partners with IT to monitor system performance and stability, ensuring business continuity and addressing operational concerns while IT handles security, infrastructure, and technical troubleshooting.
- Collaborates with IT on User Access Management, ensuring role-based access controls are in place and enforced according to least privilege principles while IT handles provisioning and de-provisioning of accounts.
- Partners with Quality and IT to uphold system validation, GxP compliance, and audit readiness, implementing corrective and preventive actions (CAPAs) as needed. Provides business input while IT executes system controls and security measures.
- Supports Data Integrity Initiatives by ensuring operational teams follow compliance best practices, while IT is responsible for data protection strategies, disaster recovery, and security protocols.
- Coordinates with IT for troubleshooting and system maintenance, ensuring business continuity while IT handles patches, updates, and security measures.
- Manages Vendor and Service Provider Relationships, ensuring external partners deliver quality services that align with business needs and compliance requirements.
- Supports New Operational Initiatives, participating in planning, process updates, and system adaptations to accommodate evolving business priorities.
- Leads End-User Training and Support, developing and delivering training sessions, creating user guides and checklists, and providing ongoing assistance to application users on system functionality, workflows, and troubleshooting.
- Acts as the Liaison between end-users, department leaders, and technical teams to ensure the application effectively supports operational and business objectives.
- Continuously Assesses and Optimizes Business Workflows, leveraging system capabilities to drive efficiency, automation, and operational effectiveness.
- Ensures Compliance with Policies and Regulations, maintaining adherence to business policies, industry regulations, and company standards for all applications within Operations.
Citizenship
- This position requires U.S. citizenship.
Requirements/Minimum Qualifications
- Bachelor's or advanced degree in Life Sciences with experience in Computer Science, Information Systems or related technical field; OR Bachelor's or advanced degree in Computer Science, Information Systems, or a related discipline with experience in life sciences.
- 10+ years of experience in a research organization with a focus on system administration, system ownership, and compliance.
- Hands on expertise and knowledge of Veeva, Provantis, and/or Benchling.
- 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.
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