Associate Manager, Quality Compliance (External Partners)

Role Summary

Associate Manager, Quality Compliance will lead a team responsible for providing quality assurance oversight of External Partners to ensure compliance with QMS requirements related to deviation reporting and investigations, CAPA compliance, and day-to-day QA support in regard to documentation review and approval.

Responsibilities

• Manage QA Compliance team operating as a counterpart to External Manufacturing to provide QA support, review and approval of QMS records including deviation, CAPA, and change control.
• Manage QMS system associated with External QA operations.
• Mentor direct reports and functional area counterparts in compliance requirements.
• Facilitate continuous improvement initiatives specific to External QA oversight.
• Ensure appropriate training programs are executed for QMS systems.
• Support regulatory and customer audits.

Qualifications

• Required: Bachelor’s degree (May substitute relevant experience in lieu of education). Minimum experience: Associate Manager: 6+ years; Manager: 7+ years.

Skills

• Knowledge of GMP compliance requirements
• Experience with electronic GMP documentation systems (Veeva a plus)
• Strong organizational skills and attention to detail
• Ability to prioritize multiple assignments and changing priorities

Education

• Bachelor’s degree (required; substitution allowed with relevant experience as described above)