Associate Director Global Quality Operations – Analytical QA

Abivax; United States; Sur place; USD 180 000 - 240 000; Plein temps

Résumé du poste

Abivax, a biotechnology company focused on improving patient lives, seeks an Associate Director, Global Quality Operations – Analytical QA in the United States. You will lead QA operations oversight of external QC testing for clinical and future commercial products, drive compliant specification development, and supervise Q-Ops staff to ensure regulatory alignment and product quality.

Ideal candidates have 10+ years in the field, strong cGMP/ICH/FDA/EMA knowledge, and experience with CMOs and

Qualifications

• Bachelor’s or Master’s degree in life sciences or related field; significant industry experience may substitute.
• Minimum 10+ years of industry experience, ideally from early clinical phases through commercial drug products.
• Strong knowledge of cGMP/ICH/FDA/EMA regulations and ability to defend Quality Operations policies during inspections.

Responsabilités

• Provide QA representation, guidance, leadership, and direction for external QC testing for clinical and commercial product release, Stability, analytical method development/transfer, and establishment of specifications.
• Manage and mentor Q-Ops staff, emphasizing teamwork, planning, follow-up and effective communication.
• Manage disposition processes for clinical/commercial products produced in contract manufacturing operations (CMO).
• Ensure quality system controls for distribution pending regulatory submissions and approvals.
• Lead cross-functional collaboration to implement GMP Quality Systems including disposition, vendor management, deviations, CAPA and change management.
• Review and approve validation protocols/reports, analytical test methods, and stability protocols/reports.

Connaissances

QA Leadership

cGMP/ICH/FDA/EMA

Regulatory Interactions

External QC Testing Oversight

Documentation & Records

Formation

Bachelor’s or Master’s in life sciences

Outils

Veeva

Description du poste

At Abivax, our purpose is simple: to improve patients' lives. As a global clinical-stage biotechnology company with headquarter in Paris and offices in the United States, we are advancing innovative therapies for people living with chronic inflammatory diseases.

We are looking for talented, purpose-driven individuals who want their work to have a meaningful impact. Every day, we challenge ourselves to ask: "How did I make a patient's life better today?" If that question inspires and motivates you, we invite you to join our team.

The Associate Director, Global Quality Operations – Analytical QA

is responsible for:

• providing Quality Operations oversight of external QC testing supporting Abivax clinical and future commercial products.
• leading compliant and efficient Specification development aligned with industry standards and in accordance with the product’s lifecycle.
• coordinating the reviews of Quality Control/Assurance records ensuring compliance to specifications, standards and phase-appropriate GMPs.
• providing Quality Operations oversight of the Stability program, protocols, testing, and reports
• providing strong leadership and GMP consultation critical to ensuring the quality and safety of Abivax’s products.

This position requires strong knowledge of cGMP/ICH/FDA/EU and the ability to defend Quality Operations processes during site inspections.

Responsibilities, Assignments, and Tasks

• Provide QA representation, guidance, leadership, and direction for external QC testing for clinical and commercial product release, Stability, analytical method development/transfer, and establishment of specifications.
• Manage and mentor Q-Ops staff, emphasizing teamwork, planning, follow-up and effective communication.
• Manage the process for the disposition of clinical / commercial products produced in contract manufacturing operations (CMO).
• Ensure appropriate quality system controls to ensure distribution of product given pending regulatory submissions and approvals.
• Foster a quality mind-set within Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
• Support review and closure of Internal and CMO generated deviations, OOS/OOT, CAPAs and change controls ensuring appropriate escalation and notification to leadership as applicable.
• Work cross functionally with other Quality functions to develop and implement GMP Quality Systems including, disposition, vendor management, deviations, OOS/OOT, CAPA and change management.
• Review and approve validation protocols/reports (e.g., process, method, etc.), analytical test methods, and stability protocols/reports.
• Interact professionally with company management, internal departments, third parties and other sites to provide effective QA oversight and guidance.
• Compile testing related metrics and effectively communicate status and recommendations to Senior Management.
• Development of Contract Manufacturing Organizations (CMO) Quality Technical Agreements (QTGs)- ensuring effective Abivax sponsor oversight.
• Support development and adherence to site quality metrics and provide input into site Quality Council.
• Support logistics associated with regulatory body inspections of Abivax and Contract Manufacturing Organizations as well as defend Quality Operations processes and programs.

Qualification Requirements

Initial Education, Training and Certification Requirements:

Bachelor’s and / or Masters’ degree in life sciences or a related field or an equivalent combination of significant, relevant industry experience and demonstrated expertise will be considered in lieu of formal education.

Professional Experience Level

Minimum 10+ years industry experience, ideally with early clinical phases through commercial drug product.

Technical Skills

• Direct experience working with CMOs to meet product disposition timelines.
• Experience in facility startup through pre-approval inspection.
• Experience with small molecule products is preferred.
• Strong knowledge of cGMP/ICH/FDA/EMA regulations particularly ICH Q1a-e, Q2, Q3a-e, Q6a and b, Q7, Q14 and FDA’s guidance on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
• Previous experience in implementation of quality procedures is preferred.
• Previous experience interacting with regulatory agencies with a successful track record of defending Quality Operations policies and procedures.
• Veeva platform, supporting inspection-ready compliance and successful operational go-live

Leadership/Behavioral Skills

• Strong management experience to lead cross functional teams to effectively resolve quality issues.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between stakeholders.
• Excellent organizational skills, ability to navigate and be successful in fast-paced work environment with changing priorities

This job description is intended to describe the general responsibilities and qualifications for this position and is not an exhaustive list of all duties. Responsibilities may change based on business needs, and Abivax reserves the right to modify this job description at any time.

Reasonable accommodation will be provided to qualified individuals with disabilities to enable them to perform the essential functions of the position.

Abivax is an Equal Opportunity Employer and makes all employment decisions without regard to any characteristic protected by applicable federal, state, or local law.