Senior Consultant, Organizational and Quality Solutions – Data and Technology
Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Organizational and Quality Solutions team as a Senior Consultant, Organizational and Quality Solutions – Data and Technology today!
In this role, you will provide senior-level subject matter expertise and advisement focused in the areas of life science organizational excellence, process optimization, quality management, data solutions and/or technology enablement. You should have an advanced understanding of the core life science functions, continuous improvement, process and performance metrics, quality and change management. You should have exceptional communication skills, and critical thinking skills, and a proven track record in successfully driving and advising the delivery of project-specific deliverables through internal and external stakeholders.
- Lead the assessment of client processes for gaps, inefficiencies and redundancies, leading teams in the analysis of results and the design of strategies and solutions to address these, driving towards more streamlined operational processes and improved efficiency and compliance
- Independently lead teams to drive projects in your area of specific subject matter expertise, stepping into a hands-on role as needs of individual projects require, including:
- Assess/audit client computer systems, data collection, standards and governance, and infrastructure for compliance gaps and inefficiencies; develop and implement remediation plans
- Define and develop client risk-based quality management (RBQM) and other risk-based decision making processes to support ICH E6 R2
- Provide operational recommendations in risk identification and mitigation when implementing GxP regulated software for clients including activities such as system selection, design, configuration, vendor auditing, risk assessment, business requirement mapping, validation planning/oversight, system documentation, software testing, data migration, and training
- Develop and implement policies and procedures defining compliant risk management, including all aspects of RBQM and quality by design (QBD)
- Evaluate current state of clients with respect to technology, specifically around RBQM, risk-based monitoring (RBM) and data visualization, data standards and data governance and develop future state roadmaps defining strategy for implementation and adoption of to meet evolving business objectives, compliance requirements, and efficiency needs
- Facilitate decision making within the Halloran team and client (e.g., brainstorming, strawman, prioritization, polling)
- Plan and facilitate workshops (e.g., process mapping, risk assessment, requirement development) or other brainstorming sessions
- Evaluate organizational maturity pertaining to modalities such as compliance, growth potential, resourcing, or culture and recommend phased solutions based on risk/impact/effort to maximize value opportunities
- Evaluate and communicate the impact of organizational change (corporate, functional, and procedural level) to ensure that recommendations are appropriately scaled
- Partner with organizations to measure and validate the effectiveness of continuous improvement and change initiatives (e.g., piloting, training, hypercare)
- Facilitate decision making within the Halloran team and client (e.g., brainstorming, workshops, process mapping, strawman, prioritization, polling)
- Act as a project lead on multi-faceted, multi-disciplinary, interrelated projects by establishing project plan, budget and methodology, proposing appropriate resource allocation options that ensure team and client happiness and success, guiding team members as needed
- Supervise, analyze and report project status, determining the impact of and mitigating any risks, developing appropriate messaging for regular communication with internal team and client partners
- Identify, mitigate and analyze the impact of any project risks, supporting timely resolution and client-facing response
- Educate existing and potential clients on Halloran services and identify future opportunities. Provide subject matter expertise in during initial client interactions. Provide early input and participate in project scope definition and proposal/statement of work
- Participate in internal activities such a developing new product offerings and consulting services, publishing articles, presenting/moderating workshops, attending conferences when opportunities arise, and contributing to process optimization and other Halloran initiatives
- Coach, mentor and manage Halloran team members (up, down, and across the organization) to achieve company and client goals, either in a direct management, project-based, or matrixed relationship
- Other duties and responsibilities as assigned
- Bachelor’s degree in a life science-related discipline, business or management, or demonstrated equivalent and a minimum of twelve years of industry experience in a life science core product development function (e.g., Clinical Operations, Clinical Affairs, Regulatory, Quality, Medical, Safety, etc.)
- Demonstrated technical understanding of adjacent functional areas
- Demonstrated history of leading risk-based quality management and/or quality by design activities in Clinical Development functions in pharmaceutical and/or biotechnology settings
- Deep familiarity with current regulatory guidance, GxP Guidelines, legislation, and industry trends and best practices
- Ability to balance multiple priorities and sophisticated issues using logical, creative, analytical, and efficient processes with a high level of attention to detail and quality of work
- Exercise good judgment in selection methods, techniques and evaluation criteria for issues that may require in-depth evaluation of variable factors
- Advanced Education and/or Certifications (Audit, Lean Six Sigma, Lean Business Process, PMP, Change Management)
- Prior Consulting experience
- Experience in organizational change (e.g., integration of acquisitions, growth/downsizing, continuous improvement, quality initiatives)
The targeted gross compensation range for this position is between $130,000.00 and $195,000.00 annually. Please note: this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.
Halloran Benefits and Perks:
The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. We offer reimbursements for Health & Wellness Programs and Memberships, opportunities for continued learning through conference and continuing education programs. We also offer a Self-Managed PTO Policy, Commuter FSA Benefits, and many other benefits.
Halloran Consulting Group, Inc. COVID-19 Considerations:
Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering Halloran’s offices, attending Halloran sponsored events (at Halloran offices or otherwise), and traveling to client sites, subject to requests for accommodation. Individuals will be considered fully vaccinated two weeks after a second shot of a two-shot vaccine regimen (i.e., Pfizer or Moderna) or two weeks after a single shot of the Johnson & Johnson vaccine.
Halloran does not sponsor visas for employees.
All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.
We are committed to equal employment opportunities for all applicants and employees. We do not discriminate against employees or applicants for employment based on any protected class including, but not limited to, race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age, veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by an authorized representative of Halloran.