Senior Consultant, Organizational & Quality Solutions (GxP Quality)
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 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, and 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 quality gaps, inefficiencies, and redundancies to lead teams in the analysis of results and the design of strategies and solutions across GxP aspects of quality management. This is including but not limited to: Quality planning, QMS development and execution, Vendor Qualification auditing and oversight of vendors (concentration on CDMOs and/or laboratories), quality organizational planning and hiring, and establishment of Quality Agreements with key partners. May handle product-related activities such as batch review and disposition, stability data review, Test Method, Equipment, and Process validation Quality Oversight.
- 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).
- Independently lead internal teams to drive projects in your area of specific subject matter expertise across GxP assessments, stepping into a hands-on role as needs of individual projects require.
- 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 during initial client interactions. Provide early input and participate in project scope definition and proposal/statement of work.
- Showcase quality subject matter expertise, serving on 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 lead 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 ten to twelve years of industry experience in life sciences product development, with a broad reach and emphasis on quality impact, including GxP Quality, QMS management and development, and/or auditing and inspections.
- Demonstrated history of leading process improvement, quality and change management, or continuous improvement activities in a life science product development function.
- Deep familiarity with current regulatory guidance, GxP Guidelines, legislation, and industry trends and best practices, strong GMP knowledge.
- Ability to make risk-based decisions and 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.
- GLP and Medical Device experience a plus.
- Experience in organizational change (e.g., integration of acquisitions, growth/downsizing, continuous improvement, quality initiatives).
The targeted base compensation range for this position is between $165,000.00 and $200,000.00 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. As of January 2020, Halloran is proud to say we’re partially Employee Owned. Our Employee Stock Ownership Plan (ESOP) allows employees who meet plan entry requirements to own a piece of the company without having to invest their own money to purchase stock. In addition to this, Halloran offers a Self-Managed PTO Policy, opportunities for continued learning through conference and continuing education programs, and many other benefits.
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.
Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws).
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.