Director, Product Quality

Compass Pathways•Dover, NH

10h•Hybrid

About The Position

This role focuses on providing strategic direction for Compass product manufacture and distribution through strategic partnership development internally and with external partners. Ensures that quality strategies for Compass operations and ensures that throughout product lifecycle for all Compass products to align with GMP / GDP requirements. As well as strategic Quality direction for Compass QMS to ensure that processes adapt to changing business needs, company goals and addresses GxP regulatory requirements.

Requirements

Broad based knowledge of the pharmaceutical industry at least 12 years’ experience in the industry of which 7 should be at a managerial level.
Scientific/engineering degree or equivalent combination of education and experience
Postgraduate qualification in Quality Management or equivalent combination of education and experience
A proven understanding of GMP, GCP, Pharmacovigilance and Quality Management requirements as applied in the industry
Excellent understanding of continuous improvement in a pharmaceutical environment
A passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma
Ability to identify appropriate KPI’s, implement and use as control mechanisms and drive change and improvement
Extensive experience of establishing and leading the QMS system and process, in a highly regulated environment across multiple sites, GxPs and locations
Proven ability to present effectively to all levels of an organisation to include project rationale and updates, strategic plans
Ability to build effective relationships (internal and external)
Excellent verbal and written communication skills, including the ability to interact effectively with different audiences
Excellent networker with the ability to collaborate and agree outcomes
Ability to understand quality issues in a complex a highly regulated environment and make data driven recommendation/decisions and take appropriate action
Proven record of leading management and staff to deliver business plans

Responsibilities

Maintain oversight of current and evolving global regulatory requirements, proactively assessing impact to Compass products and developing remediation plans where required
Provide subject matter expertise in GMP and GDP, ensuring consistent application across internal and external operations
Drive enterprise Quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimise performance, and support the Compass business through growth and transformation
Lead, develop, and coach the Product Quality team, building strong Quality capability and enabling effective Quality partnerships across the organisation
Act as the primary Quality point of contact for Compass Supply and Contract Manufacturing Organisations (CMOs)
Provide Quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains
Deputize for VP, Quality when required
Define and implement phase‑appropriate ways of working with external partners, ensuring alignment with Compass strategies and regulatory expectations
Manage all Quality aspects of commercial readiness activities, within Compass and across the extended supply chain
Drive strong, collaborative Quality relationships with CMOs, ensuring alignment with Compass QMS requirements and commercialisation objectives
Build a robust and resilient supply chain while ensuring compliant, cost-effective processes that support profitable growth
Provide strategic Quality direction to support dual supply for clinical (IMP) supply and a fully commercial supply chain