GxP Services Director

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 GxP Services Director has the responsibility, as assigned, for leadership of one of the Consulting Service lines within an increasingly diverse consulting group. The Director serves in a team leadership role and provides industry experienced support and consultancy services as an individual contributor or as part of a larger team for Advarra Consulting Client Projects. The 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 opportunities, services and project deliverables to Clients. The Director supports the Advarra Consulting Leadership by providing input to strategic design for the organization and services. The Director supports operations and resources and is accountable for the assigned service line(s) offering(s), services delivery management, and sales enablement. The Director provides training and oversight and serves as a mentor to departmental staff members and independent sub-contractors. The Director is responsible for achieving goals and objectives jointly established with Advarra Consulting Leadership. The Director represents Advarra Consulting on Business Development /Sales meetings, Marketing support and by working closely with the other Advarra Consulting Directors and Leadership to collaboratively grow the overall Advarra Consulting Group.

Position should maintain a billable utilization rate of approximately 65%.

Position may require extensive travel, up to 50% or greater at times.

Position is eligible to be home based, which requires a self-provided designated workspace that is free from distractions and interruptions, as well as maintains a high-speed internet connection.

Job Duties & Responsibilities

• Responsible for supporting the operational/financial metrics and overall business results of Advarra Consulting.
• Provide input and support for setting and driving strategic direction and ensuring profitable growth of Advarra Consulting.
• Performs consultancy services for Clients, at times serving in a lead role or supporting the Project Manager, by providing Subject Matter Expertise (SME) and oversight of assigned projects programs.
• Establishes, cultivates, and maintains relationships with specific Clients as the primary SME point of contact for service-related Client communications and serves as a point of escalation for the Client and Project Management Office (PMO) for project issues.
• Actively promotes the Advarra Consulting Service Lines through thought leadership.
• Collaborates with Commercial Sales to actively develop new approaches and opportunities to expand the customer base, as well as participate in client meetings and support the scoping of client projects including appropriate solutions, deliverables, timelines, effort for such projects.
• 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.
• Participates in Management and Infrastructure Support Meetings.
• Maintains awareness of the competitive landscape, opportunities for expansion and new industry developments
• Develops, advises and/or oversees the generation of departmental Standard Operating Procedures, Guidelines and other tools to support Consulting services.
• Grows the independent consultant base who can perform work for Advarra Consulting (may be specific to service area).
• Supports resolution of staffing issues for complex engagements.
• Performs other assignments as directed by the Advarra Consulting Management Team.

Location

This role is open to candidates working remotely in the United States.

Basic Qualifications

• Bachelor’s degree, or equivalent, from an accredited college or university required
• Preferred: Degree in Nursing, Science, or related field (or equivalent)
• Minimum of ten (10) 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
• At least four (4) + years of Quality Audit experience
• At least five (5) + years of management experience in a related field

Preferred Qualifications

• Demonstrated working knowledge, and working application, of US Code of Federal Regulations, International Council for Harmonization (ICH) and guidance’s related to human research [e.g., Office for Human Research Protections (OHRP)], required.
• Working proficiency in Microsoft Office (Word, Excel, and PowerPoint).
• Working knowledge of other regulations and guidance related to research oversight, and compliance (e.g., GDPR, 21 CFR 11, etc.) and other international research regulations related to area of expertise.
• Ability to work independently and as a team; planning, organizing, scheduling and completing work within deadlines
• Ability to manage conflicting demands and priorities through research, problem solving and critical thinking
• Attention to detail with a high level of accuracy
• Proficient project management and team building skills
• Excellent organizational and time management skills
• Outstanding interpersonal, communication, diplomacy, and writing skills
• Ability to analyze a variety of data points to solve complex 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 $97,000.00 - $165,200.00. 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.