POSITION SUMMARY
Under the direction of the Executive Vice President and Chief Laboratory Officer, provides overall management and operational direction for Pearl Pathways to ensure financially sound, state-of-the-art capabilities and growth commensurate with the long-term objectives of Versiti. In collaboration with the Director of Business Development Pearl Pathways, directs the implementation of business and operational strategies and plans to drive revenue growth. Leads management team to ensure quality standards, client deadlines, and production timelines are met. Communicates with current and potential clients to create and modify work contracts and agreements, resolve urgent or serious issues, and address questions and concerns.
DUTIES AND RESPONSIBILITIES
- Assumes overall operational responsibility for Pearl Pathways operations assets including accountability for P&L, forecasting, human capital, product development strategy, etc.
- Work directly with key internal and corporate stakeholders on strategic and annual planning and management to ensure operational excellence in the delivery of services.
- Provides strategic direction and oversight to ensure compliance with all applicable standards and regulations to ensure that regulatory changes are incorporated into standards and policy.
- Partners with clinical and business leadership to develop and implement the strategic plan for Versiti Clinical Trials (VCT) operations.
- Attend and fully participate in Versiti quality management (QM) meetings and other meetings, as appropriate, working with management to identify changes.
- Facilitate and support client visits, audits, and inquiries and interact with governmental and other agencies as appropriate and ensure that any findings are addressed in a timely and satisfactory manner.
- Achieve client satisfaction by monitoring company performance using tools to accurately assess the delivery of services.
- Review, approve, authorize, and ensure proper implementation of SOPs not under the purview of other approvers and review at least biennially.
- Participate in the design, review of, make any necessary changes to, approve annually, and oversee the implementation of QM programs.
- Ensures participation in group regulatory, certification, and accreditation training when provided.
GENERAL DUTIES
- Leads by example, motivates and inspires.
- Supports and promotes a culture of open, productive communication and responsibility.
- Represents the company at designated internal and external meetings and assumes other special assignments as designated.
- Provides customer feedback to the corresponding service teams, Diagnostic Laboratories and other operational staff.
- Upholds the company customer service standards and management philosophy.
- Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification.
- Understands and leads Pearl Pathways organization in accordance with all applicable regulatory and compliance requirements.
- Complies with all standard operating policies and procedures.
QUALIFICATIONS
Education
- Bachelor's Degree BA/BS or MSc. degree in life science or technical field (e.g., molecular biology, immunology, chemistry with strong academic performance required).
- Master's Degree MBA preferred but can be substituted through applicable business leadership experience.
Experience
- Minimum of 10 years of experience supporting clinical, quality, or regulatory required, preferably in a supervisory and/or leadership capacity.
- 10+ years previous experience with human capital, resource allocation, recruiting, and hiring required.
- 10+ years in-depth understanding of terminology, design, goals, and other key features of quality, research and/or clinical trial protocols required.
Knowledge, Skills, and Abilities
- Superior leadership and interpersonal skills including strong organizational and verbal/written communication skills required.
- Proven ability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations including superior ability to manage time, resources, and supervise technical personnel required.
- In-depth knowledge of and ability to interpret relevant regulations, requirements, and guidelines as it relates to conducting clinical trials, quality, and regulatory required.
- Ability to proactively direct and promote teamwork in a multi-disciplinary team setting required.
- Ability to present technical topics/company information at company-wide training meetings/sessions without assistance required.
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