Job Title: Deputy Director of DS Manufacturing Quality Systems

Location: Pearl River, NY

About the job

As Deputy Director, Drug Substance (DS) Manufacturing Quality Systems at our Pearl River site, you'll lead and develop a broad Quality Systems organization - spanning Principal Investigators, Technical Writers, and Quality Systems Support Associates - responsible for the full lifecycle of manufacturing quality records: deviation investigations, CAPAs, effectiveness checks, periodic reviews, and QMS document updates. You'll keep investigations on track, products moving, and patients supplied, all while driving a culture of continuous improvement and operational excellence. You'll be a key voice in audits and regulatory inspections, a coach to your team, and a connector across functions. If you thrive in a fast-paced, regulated environment where your decisions carry real business and patient impact, this role is for you.

Main responsibilities

• Lead and develop an agile Quality Systems team - including Principal Investigators, Technical Writers, and Quality Systems Support Associates - coordinating work assignments to meet fluctuating business needs while sustaining a strong learning and development culture
• Own on-time closure of Drug Substance Manufacturing deviation investigations, CAPAs, effectiveness checks, and periodic reviews of departmental quality documents to meet site performance metrics and product release timelines
• Identify and resolve roadblocks by coordinating with support groups to ensure the Manufacturing Quality System Matrix remains current and comprehensive
• Review deviations, CAPAs, and other quality records for completeness, and conduct management-level review of minor, major, and critical events ahead of Quality Assurance review
• Oversee timely and accurate document updates within the Quality Management System (QMS), ensuring documentation remains current, compliant, and audit-ready
• Coach and develop the Quality Systems team, providing continuous feedback and challenging growth opportunities while reinforcing Sanofi's culture, values, and cGMP compliance standards
• Lead cross-functional engagement with key stakeholders (Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance) to build consensus and drive timely closure of quality records
• Partner closely with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy, audit readiness, and regulatory compliance priorities
• Serve as the site representative during internal and external audits and regulatory inspections, confidently defending investigation write-ups and quality documentation on behalf of the team
• Champion a continuous improvement culture by identifying and driving new tools, process changes, and cost-reduction initiatives that reduce deviations and improve cycle time efficiency across the Quality System
• Communicate progress, updates, and escalations accurately and effectively - in writing and verbally - across multiple levels of the organization and to regulatory agencies
• Ensure all Quality System operations are conducted in full compliance with cGMPs
• Available to work extended and flexible hours, including weekends, as business needs require

Decision-Making Matrix (DAI)

The Deputy Director, DS Manufacturing Quality Systems plays a leadership role in decision-making processes across quality systems, manufacturing operations, and regulatory compliance. Responsibilities are defined as follows:

Deviation, CAPA, and Quality Record Closure

• D (Decider)

Decides on investigation scope, risk classification, and closure readiness for deviations, CAPAs, and effectiveness checks in partnership with QA.

Approves final quality records prior to Quality Assurance review.

Quality Systems Team Development and Work Assignment

• D (Decider)

Assigns work, prioritizes investigations and quality documentation tasks, and determines team development plans and coaching strategies.

Cross-Functional Consensus Building and Escalation

• A (Accountable)

Accountable for facilitating cross-functional alignment with Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance to resolve roadblocks and drive closure.

Escalates unresolved issues to senior leadership and support groups as needed.

Site Quality Strategy, Audit Readiness, and Inspection Defense

• A/I (Accountable/Informed)

Partners with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy.

Accountable for representing the site and defending quality records during audits and inspections.

Informed of broader site quality strategy and regulatory intelligence.

Continuous Improvement Initiatives and Process Changes

• D/A (Decider/Accountable)

Identifies, proposes, and decides on process improvements, new tools, and cost-reduction initiatives within the Quality Systems organization.

Accountable for driving implementation and measuring impact on deviation reduction and cycle time efficiency.

QMS Document Updates and Periodic Reviews

• A (Accountable)

Accountable for ensuring timely and compliant updates to departmental quality documents and periodic reviews within the QMS.

Delegates execution to team members but retains accountability for completeness and compliance.

cGMP Compliance and Regulatory Communication

• A (Accountable)

Accountable for ensuring all Quality Systems operations are conducted in compliance with cGMPs.

Communicates progress, updates, and escalations to regulatory agencies and senior leadership.

About You

Basic Requirements:

• Bachelor's degree in Life Sciences, engineering, Business or any related field.
• 7+ years of experience in a cGMP-regulated pharmaceutical or quality environment, with demonstrated experience leading cross-functional initiatives, projects, or quality systems.
• Strong track record making risk-based decisions independently and managing multiple high-priority, high-visibility deadlines in a dynamic setting
• Demonstrated ability to lead cross-functional consensus-building with stakeholders across Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance
• Excellent written and verbal communication skills, with the ability to engage and influence stakeholders across all levels of the organization and with regulatory agencies.

Nice to Have:

• Prior experience managing direct reports or technical teams in a regulated environment is preferred but not required. Equivalent experience leading quality systems, project teams, or independent contributors will be considered.

The salary range for this position is:
$113.250,00 - $163.583,33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.