Lead Consultant, CQV

Job Description

Job Description

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our consultants support the qualification and requalification of equipment, utilities, systems and facilities used to manufacture and test biologics and drug products at client sites and provide GMP quality assurance support to client quality organizations. Consultants work to current US and international regulations, guidance and industry best practice, coordinate activities with the client, and meet timelines. Documents prepared by Quality Agents consultants are approved by the client. Our mission is to provide cost-effective solutions by providing intelligent, driven resources to our clients, with superior quality and integrity.

The Role

The Lead Consultant manages the full project lifecycle and owns the project-level client relationship. The Lead Consultant leads project teams and coaches engineers while still doing hands-on work.

Responsibilities

• Manage the full project lifecycle for qualification and validation projects: write validation master plans, coordinate project meetings related to their execution, and see packages through to closure.
• Write site-specific and multi-site validation procedures.
• Lead commissioning and qualification activities for facility, utility and equipment start-ups, from design and requirements review through acceptance testing, qualification and summary reporting.
• Write, review and execute validation plans, IQ/OQ/PQ protocols and SOPs for equipment, systems and utilities.
• Support implementation of change requests to validated systems and resolution of process deviations through technical knowledge, supporting validation studies, and review and approval of manufacturing documentation.
• Lead investigations and troubleshooting of equipment, utilities and systems.
• Own the project-level client relationship: day-to-day client interface for the project team and ongoing assessment of the client's needs on the project.
• Lead the project team: day-to-day direction, task quality and review of deliverables for everyone staffed on the project.
• Coach engineers on the team while continuing to deliver hands-on technical work.
• Travel to client sites as projects require.
• Comply with all applicable Quality Agents and client policies on health, safety and the environment.

What Success Looks Like

Performance at Quality Agents is reviewed on six dimensions. For this role they look like this:

• Technical Expertise: Right-first-time execution across CQV, QA and validation work; models that standard for the project team.
• Regulatory Judgment and Risk Ownership: Owns project-level risk assessments and deviation and CAPA outcomes that hold up under cGMP, FDA, EMA and Annex 11.
• Delivery Scope and Complexity: Manages full projects independently, including timeline, quality and client satisfaction.
• Client Interaction and Influence: Holds trusted counterpart status with the client, is requested for repeat work, and steadies tense site situations.
• Leadership and People Development: People trained and coached execute independently; others want to work on the Lead Consultant's projects.
• Commercial Awareness: Understands how project delivery quality and client satisfaction sustain the client relationship over time.

Skills

• Ability to problem-solve and troubleshoot.
• Technical writing ability and use of Microsoft Word, Excel, PowerPoint and Project.
• Experience with validation equipment such as the Kaye validator, wireless data loggers or other monitoring devices is strongly desired.
• Experience using statistical tools to analyze data captured during validation studies is a plus.
• Excellent written and verbal communication skills.

Minimum Requirements

• BS in a technical discipline (Engineering, Chemistry, Microbiology, Biology).
• Current driver's license and auto insurance, or other dependable means of transportation.

Typical Experience

Typically, 6 to 10 or more years of experience in at least one of the following areas: equipment and utility qualification, process validation, analytical method validation, or cleaning validation. Experience ranges are a guide, not a requirement. Placement follows the scope of work you can own and demonstrated performance.

Employment

Full-time, W-2. Travel to client sites as projects require.

Every consultant has a career manager who is separate from the project lead and stays with you as you move between projects, with a monthly check-in and a yearly development plan.

Compensation and Benefits

Salary range: $125,000 to $165,000 per year. Placement within the range reflects experience and the scope of work owned.

Full-time employees are eligible for benefits including:

• Health, dental and vision insurance
• Life, AD&D and disability insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid time off
• Paid holidays
• Paid parental leave

Incentive bonuses may be awarded depending on company profitability and individual contribution.

Benefits are subject to plan documents and eligibility requirements.

Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.

Equal Opportunity & Accessibility Statement

Quality Agents, LLC is an equal opportunity employer. We make employment decisions without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law. We are committed to providing reasonable accommodation for individuals with disabilities throughout the application and hiring process. If you require assistance or accommodation, please contact us.