Quality Operations Manager

About PCI Pharma Services

We specialize in bridging biopharma companies and patients by delivering life-changing therapies globally. Our focus is on investing in people who drive progress and innovation toward a better future.

Role Summary

This role demands leadership to drive quality excellence within the business unit. It entails full ownership of quality processes, maintaining documentation standards, ensuring compliance with regulatory requirements, and acting as the main quality liaison for vital customers and initiatives.

Key Responsibilities

• Oversee quality operations including the generation and review of batch manufacturing records and ensuring production-related quality assurance.
• Collaborate with Quality Managers and the Quality Systems Manager to advance QA optimization and lead continuous improvement programs across the company.
• Develop and implement cross-site quality training and capability building to enhance operational resilience and scalability.
• Manage quality documentation governance, standardizing and updating all quality forms and records.
• Supervise deviation management, investigations, and ensure timely resolutions to quality issues while safeguarding customer satisfaction.
• Uphold strict compliance with GMP standards and customer quality agreements, fostering trust as a quality partner.
• Lead a quality operations team of approximately 10 direct reports, setting performance and operational excellence benchmarks.
• Drive accountability through performance management focused on batch completion and quality metrics.
• Promote a quality-centric culture via coaching, mentoring, and professional development initiatives.
• Conduct systematic GEMBA walks to evaluate operational conditions, cleanliness, and GMP adherence.
• Monitor product inspection and quality assessments to maintain compliance with specifications and proactively resolve issues.
• Manage quality oversight of incoming goods and related supply chain processes.
• Engage with customers at senior levels to manage quality discussions, audits, and strengthen relationships.
• Lead process improvements and innovation projects, including the transfer of new product introductions.
• Maintain expert knowledge in packaging and quality processes to support audits and guide cross-functional project leadership.

Essential Qualifications and Experience

• At least 10 years of experience in Quality within a pharmaceutical company compliant with EU GMP standards.
• 2 to 5 years of leadership or team management experience.
• Extensive knowledge of EudraLex Volume 4, including critical chapters and annexes.
• Familiarity with serialization requirements.
• Strong communication skills for senior internal and external stakeholder interaction.
• A collaborative team player who communicates openly and can direct, train, and provide clear instructions to staff, customers, and suppliers.
• Capability in designing and developing new equipment to enhance line effectiveness.
• Ability to influence and collaborate across all organizational levels to meet company goals.
• Professional demeanor representing the company effectively.
• Effective multitasking and prioritization skills, with the ability to work independently and in teams.
• Excellent problem-solving aptitude and dependable integrity.

Desirable Experience

• Familiarity with quality operations supporting batch release in alignment with Qualified Person functions.
• Experience hosting regulatory inspections.
• Detailed understanding of primary and secondary packaging processes.

Additional Information

PCI Pharma Services is dedicated to Equal Employment Opportunity and Affirmative Action. We do not discriminate based on various protected categories and are committed to fostering an inclusive culture where everyone can thrive. Our ongoing efforts include assessing people practices and policies to uphold fairness and respect at all levels.