Jobs

Description

Position Summary 

• This role is for a Senior Associate (Contractor Quality & Compliance) supporting oversight of external Contract Manufacturing Organizations (CMOs).
• The individual will ensure product quality, regulatory compliance, and operational alignment between external partners and internal teams.
• The position should be based in the United States, ideally in the Eastern Time Zone, to enable better collaboration with global stakeholders.
• The primary CMO supported is located in Canada, with additional interaction across global teams.

Day-to-Day Responsibilities

• Oversee quality and compliance activities for assigned CMOs
• Review and manage change controls (from CMO to company and vice versa)
• Handle and coordinate product complaints, including:
• Initiating and reviewing investigations
• Assessing feedback and resolution
• Manage and review deviations reported by CMOs

Review and approve:

• Annual Product Quality Reviews (APQR)
• Stability protocols, reports, and data
• Act as a key liaison between Regulatory and CMOs, including:
• Supporting document requests (e.g., Certificates of Analysis, Certificates of Compliance)
• Coordinating with internal regulatory teams and country offices
• Support regulatory submissions and variations in collaboration with internal stakeholders
• Provide ongoing oversight of product quality performance and compliance adherence

Must-Have Qualifications & Skills

• Experience in GxP environment (GMP/GDP preferred)

Strong background in:

• Quality assurance and compliance
• Change control management
• Deviation and complaint handling
• Experience working with CMOs or external manufacturing partners

Knowledge of:

• Product quality reviews (APQR/PQR)
• Stability data and protocols
• Familiarity with regulatory processes and documentation
• Ability to act as a cross-functional liaison (quality, regulatory, external partners)
• Strong communication and stakeholder management skills
• Ability to work independently and in a global environment
• Comfortable working across multiple time zones.