Director, Clinical Quality assurance

Position Summary

The Director, Clinical Quality Assurance will be responsible for a broad range of both strategic and day-to-day Quality-related matters with a significant focus in GCP Quality Assurance while reporting to the Head of Quality.

This is an exciting role for a highly qualified and motivated individual who embodies both critical thinking and relationship building. This Quality Professional will be expected to build impactful relationships, collaborations and alignment both within the Quality organization, across Atea, and with business partners, CROs, and vendors while relying on the breadth, depth and agility of their practical, hands‑on expertise to advance a fit‑for‑purpose, risk‑based approach to building quality into key projects/programs in a fast‑paced environment.

This hands‑on strategic and operational role will focus on delivering to Atea’s fast‑paced clinical program needs for multiple programs in various stages of clinical development, but with a primary focus on later-stage development and inspection readiness.

We are currently utilizing a remote/hybrid work environment. For employees located in the Boston area, we use a hybrid work schedule and we are located at a newly built work site at 225 Franklin Street in Boston. For employees not located in the Boston area work will continue to be performed remotely. Normally, work is performed in a typical office environment with heavy computer duties.

The noise level in the work environment is usually quiet. Infrequent travel may be required after pandemic risk subsides.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

Atea Pharmaceuticals, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Atea Pharmaceuticals, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

• Represent Quality and participate in designated cross‑functional project/program meetings with a focus on later‑stage development programs, including those with CROs – providing critical thinking, guidance and support on quality‑related matters.
• Lead Atea’s Inspection Readiness program for BIMO inspections, ensuring that Atea remains inspection‑ready at all times.
• Review, approve, and/or administer critical GxP documents.
• Lead, participate in, or direct GxP audits and Quality Agreements with business partners, CROs and vendors as needed.
• Effectively assess and prioritize project/program and industry risks to better anticipate outcomes and identify opportunities for improvement.
• Evaluate project/program risks and determine appropriate auditing activities based on risks and known issues.
• Collaborate with key stakeholders to establish metrics, tracking and reporting trends on the company’s state of quality and compliance to current regulations and industry standards as a means to aid in achieving a ready‑state for future inspections and continuous improvements.
• Collaborate with other subject‑matter experts across the organization…