Quality Operations Manager

Responsibilities

• Lead the development and execution of quality operations, including batch manufacturing record generation and review.
• Provide direction and leadership to the quality operations team, managing approximately 10 direct reports.
• Oversee deviation management and investigation protocols to ensure swift resolution of quality issues.
• Ensure strict adherence to GMP standards and customer quality agreements.
• Drive QA optimization strategies and continuous improvement initiatives in partnership with peer managers.
• Execute systematic GEMBA leadership walks to assess operational standards and ensure GMP compliance.
• Lead high-level customer engagement and represent the organization during customer audit processes.
• Manage quality operations across incoming goods receipt and related supply chain touchpoints.

Requirements

• Minimum 10 years of pharmaceutical quality experience operating under EU GMP standards.
• 2 to 5 years of experience in a leadership or team management role.
• Deep understanding of EudraLex Vol 4, including key chapters and annexes.
• Strong understanding of serialization requirements.
• Excellent communication skills with the ability to interact with senior internal and external stakeholders.
• Proven ability to multitask, prioritize activities, and solve complex problems.
• Ability to influence and collaborate across all levels of the organization.

Preferred Qualifications

• Experience in a quality operations department with responsibility for batch release in support of a Qualified Person (QP) function.
• Experience hosting regulatory inspections.
• Detailed understanding of both primary and secondary packaging processes.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.