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. 

Work Environment:

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.

Equal Opportunity Employer Statement:

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.

Responsibilities:

·       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 and externally to conduct cross-functional investigations, risk management, and mitigation plans.

·       Working in alignment with functional representatives, propose, initiate, and prepare SOPs and other governance documents, as needed.

·       Apply the quality system to effectively manage GxP activities – document management, quality issues, deviations, CAPA, investigations, and continuous improvements.

·       Actively participate in the preparation of Quality Management Reviews and Quality Plans.

·       Work with the Quality organization to deliver and maintain a Quality Manual and with functional heads to ensure that the manual reflects the current standards of quality for the organization.

·       In collaboration and alignment with the Quality organizational and functional representatives, provide the critical thinking to facilitate a proactive and ongoing approach to inspection readiness in preparation of future inspections by global Regulatory Health Authorities, of internal Clinical and Pharmacovigilance functions and systems, Partner/CROs, and vendors.

·       Lead Quality investigations, providing critical thinking and approval of plans for resolution Quality issues; provide oversight of appropriate CAPAs associated with deviations and investigations.

·       Stay current with industry developments including forthcoming regulations, guidance, best practices, etc.; provide training and mentoring to staff on global GxP regulations and guidance.

·       Manage personnel/direct reports and coordinate consultant/contractor efforts as needed.

·       Provide input and justification for budgetary and resourcing needs.

Qualifications:

          ·      BA/BS degree in a scientific field is required.

·       Minimum of 15 years of progressive responsibility in pharmaceutical/biotech GCP/GLP/GVP-related Quality environments; experience at the Director level and managing direct reports is a plus.

·       In-depth working knowledge of global GCP/GVP regulations and guidelines including implementation of ICH guidance documents, SOPs and processes.

·       Extensive hands-on experience both in developing and managing quality plans – including CRO and vendor audits, quality reviews, and risk-based assessments; GCP/GVPGLP auditing experience is a plus.

·       Demonstrated know-how at incorporating a fit-for-purpose, risk-based approach to assuring quality and compliance to applicable regulations, patient safety and business needs while developing KPIs and metrics for fast-paced programs.

·       Direct experience in successfully preparing for and managing Health Authority Inspections and multiple projects and responsibilities concurrently.

·       Experience with electronic document/data management systems including Document Management, TMF, and QMS.

·       Track record of delivering in a fast-paced, innovative, dynamic environment.

  ·       Excellent cross-functional relationship building and critical thinking skills to work across an organization and with business partners, CROs, and vendors.

·       Collaborates and communicates transparently, listening and understanding effectively, and inviting response and discussion with key stakeholders to gain alignment.

·       Demonstrates critical, risk-based thinking, and problem solving to anticipate and work with others to resolve issues proactively and collaboratively – resolving conflict and gaining alignment effectively.

·       Comfortable in a fast paced, results-driven, highly accountable environment with lasting impact.

·       Comfortable in sharing responsibilities and ensuring alignment with management and key stakeholders.

·       Proven track record working with CROs, vendors, and relationship management.

·       Sound judgment and commitment to ethical conduct.

·       Excellent leadership skills including an effective written and oral communication skills, including experience preparing and making presentations to executive level management, and interacting effectively with internal and external organizations, collaborators, and customers.

·       Willingness to travel up to approximately 25%.