Senior 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 Senior Consultant leads technical work streams with minimal oversight and carries deep expertise in one or more service areas. The Senior Consultant mentors and reviews junior staff.

Responsibilities

• Lead technical work streams: plan, write, execute and close out qualification and validation packages (IQ, OQ, PQ, temperature mapping and requalification) for cGMP equipment, systems, utilities and facilities.
• Evaluate the equipment, utilities, systems and procedures used in development, production and holding of pharmaceutical products and determine the validation approach.
• Review and approve documented test results and maintain records for later analysis.
• Lead non-conformance handling, investigations and troubleshooting of equipment, utilities and systems.
• Support the validation aspects of facility start-up, redesign, retrofit and expansion, including commissioning, acceptance testing, design and requirements reviews, and traceability to user requirements.
• Coordinate validation activities with the client and meet timelines.
• Mentor junior staff and review their work.
• Travel to client sites and work independently to complete tasks.
• 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: Protocols and reports authored and approved without major rework; right-first-time execution in one or more service areas.
• Regulatory Judgment and Risk Ownership: Deviations and CAPAs on the work streams led are investigated and closed cleanly; risk assessments hold up under cGMP, FDA, EMA and Annex 11.
• Delivery Scope and Complexity: Runs qualifications and technical work streams independently and handles schedule complexity with minimal oversight.
• Client Interaction and Influence: A trusted counterpart for the client on the work streams led.
• Leadership and People Development: Reviews the work of junior staff constructively; people mentored execute independently.
• Commercial Awareness: Understands how the work on each stream connects to delivery quality and 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, 4 to 7 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: $100,000 to $135,000 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.