VP Quality Medical Devices jobs

Description

On behalf of our client, an expanding biopharmaceutical manufacturing leader, we are conducting a search for a Vice President of Analytical Operations & Quality Control.

Our client operates a comprehensive, commercial-scale cGMP biomanufacturing campus dedicated to accelerating advanced therapies from early development through pivotal commercial supply. Partnering with pioneering biotech sponsors, clinical innovators, and academic researchers, their technical team provides end-to-end process development, analytical characterization, and GMP manufacturing solutions.

The organization cultivates an agile, high-accountability scientific environment focused on patient impact, technical precision, and operational excellence. This executive mandate represents an opportunity to shape the quality control infrastructure of an enterprise positioned at the forefront of the advanced therapies sector.

Role Purpose & Mandate

The Vice President will establish, direct, and scale a fully autonomous, commercial-grade GMP Analytical Quality Control division. Serving as the primary technical authority for product testing, batch release, and compliance verification, this executive ensures complete method reliability across clinical and commercial vector programs.

Operating independently from yet in close alignment with Analytical Development, the VP assumes enterprise accountability for all GMP lot release assays, in-process testing, stability oversight, environmental monitoring, raw material clearance, and contract testing laboratories. Additionally, the VP acts as a key executive partner across Operations, Quality Systems, Regulatory Affairs, and Client Program Delivery.

Core Responsibilities

Strategic Leadership & Organizational Scaling

• Department Architecture: Build and mature a world-class QC organization, establishing governance models, standardized workflows, operational rigor, and high-performance norms across all analytical teams.
• Operational Strategy: Drive the end-to-end execution framework for analytical testing, ensuring rapid release cycles, stringent compliance with USP/EP/JP compendia, robust assay qualification, and complete audit readiness.
• Advanced Modality Oversight: Provide overarching scientific leadership across diverse analytical domains, including bioassays (potency, infectivity, replication-competence assays), molecular biology (genomic titers, sequencing, vector integrity), and physicochemical characterization (capsid ratios, purity, aggregate profiling).
• Facility Contamination Control: Direct microbiological quality, bioburden testing, and comprehensive environmental monitoring strategies across sterile manufacturing areas and cleanroom environments.
• Method Lifecycle & Tech Transfer: Partner with upstream development leadership to institutionalize formal analytical transfer protocols, qualifying robust methods prior to GMP implementation.
• Capital & Resource Planning: Oversee departmental budgeting, headcount modeling, instrumentation investments, and laboratory footprint expansion to keep pace with commercial growth.
• Enterprise Risk Governance: Serve as an executive point of escalation for complex quality investigations, regulatory inquiries, and program milestones.

GMP Execution, Laboratory Systems & Compliance

• Technical Redundancy & Continuity: Maintain comprehensive cross-training matrices and redundancy across critical analytical platforms to prevent operational bottlenecks.
• Manufacturing Alignment: Partner closely with production leaders to define clear analytical turnaround times, sample hand-off chains, and immediate escalation workflows for out-of-trend (OOT) or out-of-specification (OOS) data.
• Validation Standards: Ensure comprehensive validation, qualification, and verification of analytical methodologies per ICH Q2 standards, FDA/EMA regulations, and global GMP guidelines.
• Investigation Management: Drive rigorous root-cause analyses, deviation assessments, and effective CAPA implementation across all analytical workflows.
• Regulatory & Audit Representation: Function as the chief technical subject matter expert for QC during regulatory health authority inspections and customer quality audits.
• Digital Systems & Data Integrity: Enforce strict ALCOA+ data integrity standards across all laboratory operations; lead the ongoing deployment and optimization of electronic Laboratory Information Management Systems (LIMS) and Part 11 compliant digital architectures.

Stability Governance & External Partner Management

• Stability Architecture: Direct ICH Q1A/Q1B-compliant stability programs across all stages of development and commercial shelf-life verification, ensuring rigorous statistical trending and reporting.
• Contract Laboratory Management: Oversee external analytical testing vendors, managing quality agreements, statement of work execution, testing turnaround, and data integration.

Cross-Functional Collaboration & Talent Development

• Quality & Regulatory Interface: Partner seamlessly with Quality Assurance on formal change control processes, inspection preparedness, and regulatory filing support.
• External Client Interface: Represent the organization’s analytical testing strategy in key client technical committees and regulatory submission meetings.
• Talent Strategy: Recruit, mentor, and retain top-tier scientific talent; design multi-tiered career pathways and execute shift scheduling models to support continuous multi-shift GMP operations.

Candidate Profile & Required Qualifications

• Educational Background: Advanced degree (Ph.D. or Master’s) in Analytical Chemistry, Biochemistry, Molecular Biology, Virology, or a related scientific field, paired with 15+ years of progressive biopharmaceutical industry experience within regulated cGMP settings (or equivalent blend of education and senior leadership tenure).
• Modality Expertise: In-depth technical mastery of analytical and quality paradigms for complex biologics and genetic therapies (AAV, viral vectors, or cell/gene therapies), including sterile fill/finish and commercial product lifecycles.
• Senior Executive Experience: Demonstrated history of building and leading sizable, high-performing GMP Quality Control or Analytical Operations organizations within advanced therapy or biomanufacturing sectors.
• Analytical Breadth: Deep hands-on and managerial familiarity with viral vector characterization techniques:
• • Molecular assays (e.g., ddPCR, qPCR, NGS, capsid packaging analysis).
  • Cell-based biological assays (e.g., cell viability, viral potency, transduction assays, tcID50).
  • Protein biochemistry and biophysical tools (e.g., UPLC/HPLC, capillary electrophoresis, mass spectrometry, ELISA).
• Regulatory & Inspection Acumen: Proven record leading successful FDA, EMA, or other health authority facility inspections, with deep familiarity with ICH guidelines (Q1, Q2, Q5, Q6), 21 CFR Part 211, and Annex 1.
• Contract Services Exposure: Prior success operating within client-facing, multi-product environments (such as a CDMO, CMO, or complex partner-driven biopharma ecosystem).
• Executive Communication: Exceptional ability to distill nuanced scientific and regulatory data into actionable strategic insights for executive boards, corporate partners, and regulatory bodies.
• Location: Physical presence onsite is required to lead laboratory operations and operational teams.

Preferred Attributes

• Successful track record supporting late-stage commercialization milestones, including BLA/MAA authoring, Process Performance Qualification (PPQ) analytical testing, and commercial launch readiness.
• Direct experience leading Pre-Approval Inspection (PAI) defense for biologics or advanced therapy products.
• Practical background leading Manufacturing Science and Technology (MSAT) or analytical method transfer teams within contract manufacturing networks.
• Demonstrated leadership in LIMS selection, custom workflow build-out, and enterprise laboratory digitization.

Working Conditions

This executive role requires dedicated onsite engagement to maintain visible scientific leadership and operational governance across laboratory suites and administrative offices. The role involves routine walking between laboratory environments, gowning in classified spaces, and occasional lifting of laboratory supplies (up to 25 lbs). Domestic and international travel (up to 25%) may be required to support partner interactions, supplier assessments, and scientific symposiums.

Our client is an equal opportunity employer committed to fostering an inclusive, high-caliber scientific culture without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.