Lead Consultant, GCP 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 Consulting Group, Inc. today!
Halloran is looking for a Lead Consultant to join its Quality practice area. As a Lead Consultant, GCP Quality, you will be responsible for providing clinical quality assurance expertise to clients in pharmaceutical, biotech, and medical device industries. This role will require one to utilize their background and expertise in GCP quality management to drive our firm’s strategic quality business and provide consulting expertise to clients.
- Ensure successful engagement scoping, execution, and delivery of client work
- Set and manages client expectations.
- Develop novel methodologies to carry out project objectives; establishes timelines, quality objectives and resource objectives
- Lead, manage, and perform the following consulting:
- 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
- Execute Quality Assurance (QA) tactical plans to meet Quality objectives and goals
- Develop audit agendas, conduct audits and document audit findings
- Conduct complex tasks across multiple QA Systems such as Standard Operating Procedure (SOP) management, non-conformance mitigation, Corrective and Preventative Action (CAPA)
- Serve as an interim Quality Assurance resource for Halloran clients, including gap analysis, quality system maintenance, training, and general quality consulting
- Review client Standard Operating Procedures (SOPs) for gaps and redundancies, designing revision plans to address gaps, streamline content, and improve compliance
- Work with clients to plan GCP and QMS audits, including setting specific objectives, establishing audit criteria, and developing audit agendas
- Conduct a variety of audit activities which may include but not be limited to, GCP and device vendor audits, clinical study specific audits (e.g. investigator site, TMF), QMS, and internal process audits
- Lead client engagement and supervise junior level consultants, including assessing and ensuring client satisfaction as well as current and future needs of the client development team; oversee administrative client management tasks such as invoicing, bookings, etc.
- 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
- Bachelor’s Degree and a minimum of ten years of experience in Quality Assurance at a sponsor company
- Deep experience in GCP
- Post-graduate course work
- Certification or advanced training
- Previous experience with small and growing biotechnology and pharmaceutical companies
- 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
Our company is committed to equal employment opportunity. We will 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 [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.