Managing Director, GxP Services

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Overview Summary

The Managing Director, Advarra Consulting has the responsibility, as assigned, for leadership of one or more of the Consulting Service lines within an increasingly diverse consulting group. The Managing Director serves in a team leadership role, operates as a client liaison, and provides consultancy services as an individual contributor or as part of a larger team for Advarra Consulting Client Projects. The Managing Director professionally applies working knowledge and expertise in applicable GxP operations roles (e.g., Clinical, Manufacturing, Laboratory, etc.), quality assurance, and other diverse areas, as assigned by the management team, to effectively manage services and project deliverables to Clients. This leadership role supports the Advarra Consulting Leadership by providing input to strategic design for the organization and services. The Managing Director leads operations and resources and is accountable for people management on the engagements in the assigned service line(s), services delivery management, and sales enablement. The role provides training and oversight and serves as a mentor to departmental staff members and independent sub-contractors. The role is responsible for achieving goals and objectives jointly established with Advarra Leadership. The Managing Director represents Advarra Consulting on Business Development /Sales meetings and must work closely with the other Advarra Consulting Managing Directors and Leadership to collaboratively grow the overall Advarra Consulting business.

Position should maintain a goal of a billable utilization rate of 25%. Position may require extensive travel, up to 50% at times.

Job Duties & Responsibilities

• Responsible for supporting the operational/financial metrics and overall business results of Advarra Consulting Quality COE, and support of other COEs as assigned
• Provide input and support for setting and driving strategic direction and ensuring profitable growth of Advarra Consulting Quality COE
• Collaborate with Advarra Consulting leadership to develop an annual proposed budget that supports the strategic plans, and execute against the strategic plans and budget as approved and in a prudent manner that preserves and maximizes the resources of the organization
• Provide operational leadership to ensure resources are allocated and directed appropriately to accomplish agreed-upon projects and priorities
• Support the development of metrics and dashboards to facilitate assessment of the success of the organization.
• Collaborate with Business Development to actively develop new approaches and opportunities to expand the customer base
• Identifies, leads, or oversees the development of Client solutions and product offerings.
• Responsible for the quality and timeliness of consulting delivery and maintaining customer satisfaction
• Creates and implements operational processes to drive consistency and support achievement of Advarra Consulting’s business strategy
• Interacts with executive levels internally and externally regarding matters that influence strategies and strategic relationships
• Manages and leads through individual contributors who are either Advarra Consulting FTEs or independent consultants, as assigned
• Cultivates cross-functional communications through the creation and maintenance of relationships with other Advarra areas
• Provides training, oversight, and serves as a mentor to departmental staff members and independent sub-contractors, as applicable
• Performs consultancy services for Clients, at times serving in a lead role, establishing, cultivating and maintaining relationships with specific Clients as the primary point of contact for service-related Client communication and cross-project issues
• Participate in Management and Infrastructure Support Meetings
• Build a culture of operational excellence and customer service for all customers of Advarra Consulting
• Maintain awareness of the competitive landscape, opportunities for expansion and new industry developments
• Develop, advise or oversee the generation of departmental Standard Operating Procedures, Guidelines and other tools to support Consulting services
• Grows the independent consultant base who are able to perform work for Advarra Consulting (may be specific to service area)
• Resolves staffing issues for complex engagements
• Actively promotes the Advarra Consulting Service Lines through thought leadership
• Performs other duties as assigned

Location

This role is open to candidates working remotely in the U.S.

Basic Qualifications

• Minimum of twelve (12) years of Quality Assurance and/or GxP operations (e.g., Clinical, Manufacturing, Laboratory, etc.) experience in pharmaceutical, biotech, medical device, and other applicable life science industries
• Strong Quality Assurance management experience and knowledge in Clinical, Laboratory, Manufacturing, and/or Pharmacovigilance experience
• Minimum Five (5) + years of Quality Audit experience
• Minimum Five (5) + years of management experience in a related field

Preferred Qualifications

• Demonstrated working knowledge, and working application, of US Federal regulations - FDA, International Council for Harmonization (ICH) GCP and guidance related to human research [e.g., Office for Human Research Protections (OHRP)], required
• Working knowledge of other regulations and guidance related to research oversight, and compliance (e.g., GDPR, Part 11, etc.) and other international research regulations
• Prior experience in clinical research and/or independent consulting a plus
• Strong skill in interacting with multiple clients simultaneously
• Skill in the use of computers and software programs, preferably in a PC, Windows-based operating environment
• Skill in organizing projects, tasks, and establishing priorities
• Skill in examining, developing, and editing procedures; organizing resources, establishing priorities
• Knowledge of project management principles and practices in order to manage conflicting demands and priorities through research, problem solving and critical thinking
• Knowledge of technological tools to complete assigned work
• Ability to work effectively with a number of internal and external stakeholders
• Ability to work independently and as a team; planning, organizing, scheduling and completing work within deadlines
• Attention to detail with a high level of accuracy
• Ability to develop and maintain systems and procedures related to project and tasks management; high volume of routine tasks and long-term projects
• Ability to develop, plan, and implement short- and long-range goals, gather data, compile information and prepare reports
• Ability to communicate effectively, both orally and in writing; write and edit written materials, explain complex information clearly and concisely
• Ability to apply knowledge to unique fact patters, analyze and solve problems

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary workstation
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Learn and comprehend basic instructions
• Focus and attention to tasks and responsibilities
• Verbal communication; listening and understanding, responding, and speaking

Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.

Pay Transparency Statement

The base salary range for this role is $130,500.00 - $221,900.00. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.