Principal Consultant, 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 and push beyond the status quo? Join Halloran’s Quality team as a Principal Consultant, GxP Quality today!
As a Principal Consultant, GxP Quality, you will provide leadership, strategic vision and support to the development quality consulting business to ensure successful engagement, scoping, execution and delivery of client work. Additional responsibilities include providing creative and strategic quality and compliance approaches to meet the unique needs of each client, acting as head of quality for the development-stage business, and leading and managing quality team members.
- Ensure successful engagement, scoping, execution and delivery of client work
- Provide creative and strategic quality and compliance approaches that meet the unique needs of each client
- Develop novel methodologies in their area of expertise
- Establish timelines, quality objectives and resource objectives for a project
- Defines methodology for practice area within their area of expertise
- Lead and manage quality team members to ensure client, employee, and company goals are achieved, either in a matrixed or direct management relationship
- Provide leadership, oversight, and/or delivery of the following quality consulting services:
- Serve as an interim Head of Quality Assurance for Halloran clients, assuming all leadership aspects of the role within the sponsor/client organization
- Establish and/or revise client Quality Management Systems
- Develop of inspection readiness initiatives, including inspection readiness planning for sponsors, sites and vendors, inspection readiness training and coaching, mock inspections, and inspection response remediation
- Conduct organizational analyses/assessments and recommends/performs remediation efforts across small, growing, and large sponsor/client companies
- Develop and execute Quality Assurance (QA) plans that meet client’s Quality objectives and goals
- Create client Standard Operation Procedures (SOPs); review of SOPs for gaps and redundancies – designing revision plans to address gaps, streamline content, and improve compliance
- Work with clients to plan and conduct GxP audits, including setting specific objectives, establishing audit criteria, developing audit agenda, and documenting audit finding
- Serves as the client Engagement Lead for key Halloran clients
- Publish and speak at industry meetings and participate in professional consortia, working groups, etc. in one or more practice area
- Contribute to business development efforts, including the authoring of proposals for new client engagements, identifying business development opportunities in existing clients and educating clients on Halloran services, and utilizing consulting network to identify new clients, prospects and business opportunities
- Other duties and responsibilities as assigned
- A Bachelor’s degree in life science or similar field and a minimum of sixteen years of both tactical and strategic experience in pharmaceuticals/biopharmaceuticals/biotech and/or related industries with a concentration in one of more of the following functions: Quality, Quality Systems, Regulatory Compliance & Intelligence, Clinical Development, Operational Excellence, Inspection Preparation, Root Cause Analysis and Risk Assessment
- In depth knowledge of global GxP regulations and standards and good regulatory compliance practices, policies, and procedures
- Depth of experience and expertise in Good Clinical Practice (GCP) focused-Quality Assurance
- A strong customer focus and ability to prioritize and adapt to business needs are required
- Demonstrated project management skills; experience leading and participating on cross-functional teams
- Experience communicating/presenting to various levels of senior management and external agencies/partners
- Extensive knowledge of investigation techniques and tools
- Extensive knowledge of risk assessment strategies and tools
- Previous experience with small and growing biotechnology and pharmaceutical companies
- Experience in Good Pharmacovigilance Practices (GVP/PVQA), Medical Affairs
- Post-graduate coursework
The targeted gross compensation range for this position is between $175,000.00 and $210,000.00 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. Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.
Halloran Benefits and Perks:
- Annual, discretionary bonus based on company and individual performance
- Comprehensive Medical, Dental, and Vision Insurance
- 401(k) Plan for all full-time employees
- Reimbursements for Health & Wellness Programs and Memberships
- Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
- Self-Managed PTO Policy
- Commuter FSA Benefits
Halloran is committed to equal employment opportunities for all applicants and employees. Halloran does 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.
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.