Executive Director, Operations Quality Management

Job Description

Leads the Operations Quality Management (OQM) group dedicated to optimizing the efficiency and compliance of Development Operations functions (Clinical Operations, Biostatistics, Clinical Data Management, Statistical Programming and R&D Strategic Outsourcing) and clinical study execution teams. The OQM group is responsible for 1) Process, Standards and Training, 2) TMF Management, and 3) Development Operations Compliance. The leader is responsible for advancing the infrastructure and deliverables in these areas, cross functional relations, resource recruitment and development, and developing/maintaining reports and metrics. The leader for this group will represent Development Operation and study teams and liaise with Quality Assurance in projects and initiatives related to quality and compliance, audit management, and inspections readiness efforts.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Lead the Operations Quality Management group including defining/executing department vision/roadmap and staff hiring/development. Partner with the Development Operations (DevOps) leadership team in ensuring well executed clinical studies by implementing compliance strategies and solutions. Liaise with QA to ensure processes and compliance mechanisms are sufficient to meet Quality expectations and requirements. Oversee day-to-day compliance efforts in support of ongoing clinical programs. Implement tools and approaches for remediation of identified risks or compliance issues. Publish metrics and KPIs to keep the DevOps leaders informed of key risk indicators and efficiencies efforts. Oversee Development Operations process creation and optimization. Oversee the design and delivery of training management tools and initiatives. Oversee the TMF management for Exelixis studies to ensure inspection readiness. Partner with QA and support the SVP of Development Operations in representing the voice of quality and building the culture of quality and compliance in DevOps. Oversee Development Operations inspection readiness initiatives. Serve as the Development Operations point of contact for audits and inspections Partner with QA in the management of process deviations, CAPAs and audit/inspection finding resolution and close out. Support the implementation of systems as relates to eTMF and CTMS with the goal of effective implementation and roll out strategies All other duties as required.

SUPERVISORY RESPONSIBILITIES: Manages staff and resources as assigned.

EDUCATION/EXPERIENCE/SKILLS: Education: MS, MPH, PharmD or similar degrees in biological sciences or related field

Experience: At least 16 years of relevant pharmaceutical industry experience An in depth understanding of GCPs. Experience with developing SOPs and department processes. Experience with quality assurance audits Experience with training and mentoring clinical research staff. Responsible for setting goals for each direct report Responsible for the evaluation of performance of each direct report, performance planning and professional development Responsible for general assessment of remaining department personnel goals and performance Ensure appropriate performance management of all team members Empowers staff through leadership and training to maximize their potential and create a positive work environment

Knowledge/Skills/Abilities: A strong working knowledge of US FDA, EU and GCP regulations is required. Must be detail oriented, self-motivated, organized and have the ability to prioritize work. Additionally, must be able to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situation and deadlines. Strong communication and presentation skills also required. Must be able to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally. Must have the ability to present formally within area of expertise to a diverse audience. Additionally, must be able to communicate with regulatory agencies, when applicable. Must be able to travel without restriction. Office-based environment on non-travel days, requires ability to sit for long periods of time operating computer/telephone.

JOB COMPLEXITY:

Has a major impact on the company's ability to deliver products, or medical solutions, generate revenue, or implement resource solutions (finance, people, material)

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.