Director, Product Quality

Job overview:

The Director, Product Quality provides strategic direction for Compass product manufacture and distribution through internal and external partnership development.

This role ensures quality strategies across Compass operations and throughout the product lifecycle for all Compass products, maintaining alignment with GMP/GDP requirements. The Director, Product Quality also guides the Compass QMS to ensure processes adapt to changing business needs, company goals, and GxP regulatory requirements.

Location: Hybrid in our New York City office or remote on the East coast, USA. 

Reports to: Vice President, Quality.

Roles and responsibilities 
(Include but are not limited to): 

QA Expertise

• 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

Leadership

• Drive enterprise Quality strategy across Supply Chain, Manufacturing, and QMS to reduce operational risk, optimize 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 organization

• Act as the primary Quality point of contact for Compass Supply and Contract Manufacturing Organizations (CMOs)

• Provide Quality support and oversight for Manufacturing and Supply, spanning both IMP and commercial supply chains

• Deputize for VP, Quality when required

Product Quality Management

• 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 commercialization 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

Candidate Profile:

• 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 organization 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